Sample records for fda workshop testing
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Read Across Approaches: Chemical Structure and Bioactivity ...
Presentation for FDA-CFSAN and ILSI workshop on Workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments Presentation for FDA-CFSAN and ILSI workshop on Workshop: State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments
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Identify and Translate Learnings from On-Going Assay ...
Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments
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20170228 - Identify and Translate Learnings from On-Going ...
Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments Presentation for FDA-CFSAN ILSI workshop on State of the Science on Alternatives to Animal Testing and Integration of Testing Strategies for Food Safety Assessments
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Agenda: EDRN FDA Education Workshop — EDRN Public Portal
The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-19
... for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``FDA... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...
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77 FR 12313 - Food Labeling Workshop; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Dallas...
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75 FR 29775 - Food Labeling Workshop; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2010-N-0001] Food and Drug Administration Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest...
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75 FR 74736 - Food Labeling Workshop; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest...
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77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device development--namely, business planning and...
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75 FR 21007 - Food Labeling; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food Labeling; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Dallas...
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77 FR 59404 - Food Defense; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food Defense; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest...
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An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings. In making this workshop unique, a case study approach was used to discuss issues related to
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Warehouse Sanitation Workshop Handbook.
ERIC Educational Resources Information Center
Food and Drug Administration (DHHS/PHS), Washington, DC.
This workshop handbook contains information and reference materials on proper food warehouse sanitation. The materials have been used at Food and Drug Administration (FDA) food warehouse sanitation workshops, and are selected by the FDA for use by food warehouse operators and for training warehouse sanitation employees. The handbook is divided…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-06
... for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following public... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...
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Vostal, Jaroslav G; Buehler, Paul W; Gelderman, Monique P; Alayash, Abdu I; Doctor, Alan; Zimring, James C; Glynn, Simone A; Hess, John R; Klein, Harvey; Acker, Jason P; Spinella, Philip C; D'Alessandro, Angelo; Palsson, Bernhard; Raife, Thomas J; Busch, Michael P; McMahon, Timothy J; Intaglietta, Marcos; Swartz, Harold M; Dubick, Michael A; Cardin, Sylvain; Patel, Rakesh P; Natanson, Charles; Weisel, John W; Muszynski, Jennifer A; Norris, Philip J; Ness, Paul M
2018-01-01
The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products. A full record of the proceedings is available on the FDA website (http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm). The contents of the summary are the authors' opinions and do not represent agency policy. © 2017 AABB.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-18
...] Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop... Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled ``Ethical and... provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for...
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76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-02
... workshop will be held in the Great Room at the FDA White Oak Conference Center, Bldg. 31, Rm. 1503, 10903... requests to make oral presentations, as well as presentation materials, must be sent to the contact person... sterilization process, potentially resulting in HAIs or other adverse patient outcomes. FDA receives reports of...
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76 FR 60505 - Food Defense Workshop; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-29
... space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at... businesses, with firsthand working knowledge of FDA's regulations and compliance policies. This workshop is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...
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Biomarkers of Tobacco Exposure: Summary of an FDA-sponsored Public Workshop
Chang, Cindy M.; Edwards, Selvin H.; Arab, Aarthi; Del Valle-Pinero, Arseima Y.; Yang, Ling; Hatsukami, Dorothy K.
2016-01-01
Since 2009, the United States (U.S.) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards. On August 3–4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: 1) approaches to evaluating and selecting biomarkers; 2) biomarkers of exposure and relationship to disease risk; 3) currently-used biomarkers of exposure and biomarkers in development; and 4) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems (ENDS). This paper synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation. PMID:28151705
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77 FR 14813 - Public Workshop on Minimal Residual Disease; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-13
... the American Society of Clinical Oncology and will be the first in a series of workshops intended to.... This workshop is part of a series in which FDA's Office of Hematology and Oncology Products will...
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Workshop Report: Crystal City VI-Bioanalytical Method Validation for Biomarkers.
Arnold, Mark E; Booth, Brian; King, Lindsay; Ray, Chad
2016-11-01
With the growing focus on translational research and the use of biomarkers to drive drug development and approvals, biomarkers have become a significant area of research within the pharmaceutical industry. However, until the US Food and Drug Administration's (FDA) 2013 draft guidance on bioanalytical method validation included consideration of biomarker assays using LC-MS and LBA, those assays were created, validated, and used without standards of performance. This lack of expectations resulted in the FDA receiving data from assays of varying quality in support of efficacy and safety claims. The AAPS Crystal City VI (CC VI) Workshop in 2015 was held as the first forum for industry-FDA discussion around the general issues of biomarker measurements (e.g., endogenous levels) and specific technology strengths and weaknesses. The 2-day workshop served to develop a common understanding among the industrial scientific community of the issues around biomarkers, informed the FDA of the current state of the science, and will serve as a basis for further dialogue as experience with biomarkers expands with both groups.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-05
...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for.... The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Battery... create awareness of the challenges related to battery-powered medical devices and collaboratively develop...
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75 FR 76018 - Third Annual Sentinel Initiative Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-07
...] Third Annual Sentinel Initiative Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION... workshop: Third Annual Sentinel Initiative Public Workshop. Hosted by the Engelberg Center for Health Care..., including an update on Mini-Sentinel and related activities, near-term plans for FDA's Sentinel Initiative...
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77 FR 14814 - Tobacco Product Analysis; Scientific Workshop; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-13
... work to develop tobacco reference products that are not currently available for laboratory use. Discuss... methods used to analyze tobacco products. FDA will invite speakers to address scientific and technical matters relating to the testing of tobacco reference products and the analytical methods used to measure...
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75 FR 57804 - Safe Use Initiative; Public Workshop; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-22
...] Safe Use Initiative; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS...) is announcing a public workshop entitled ``Safe Use Initiative.'' This public workshop, organized and hosted by FDA's Safe Use Initiative Team, will communicate the status of ongoing activities and the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2015-08-03
...] Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments AGENCY: Food... workshop entitled ``FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data.'' The... to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-21
...] Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the... Administration (FDA) is announcing the following public workshop entitled ``Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle.'' The topics...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-13
...] Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and... entitled ``FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of... research. The purpose of this public workshop is to provide a forum for discussing the validity...
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76 FR 55068 - Mobile Medical Applications Draft Guidance; Public Workshop; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Mobile Medical Applications Draft Guidance; Public Workshop; Correction AGENCY: Food and Drug... announced a public workshop entitled ``Mobile [[Page 55069
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Workshop for Open Source Universal Picture Archiving and Communication Systems (PACS)
2006-12-01
Gap! Michael J. Ackerman, PhD NLM/NIH 2:00pm Triple Helix Model Conrad Clyburn TATRC 2:30pm Perspectives from FDA Alford Taylor CDRH ...Medical Robotics, BRSS, STAT- Care and Retinal Imaging) 57 An FDA Perspective Alford Taylor, Jr., CDRH /FDA Issues • CDRH mission is to protect
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...
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78 FR 67168 - Sixth Annual Sentinel Initiative; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-08
...] Sixth Annual Sentinel Initiative; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION... workshop entitled ``Sixth Annual Sentinel Initiative.'' Convened by the Engelberg Center for Health Care... product surveillance. Topics will include an overview of the status of FDA's Sentinel Initiative and...
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Nagaraja, Srinidhi; Di Prima, Matthew; Saylor, David; Takai, Erica
2017-08-01
In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In addition to the above topics, best practices for these various tests were discussed, and knowledge gaps were identified. Prior to the workshop, discussants had the option to provide feedback and information on issues relating to each of the topics via a voluntary preworkshop assignment. During the workshop, the pooled responses were presented and a panel of experts discussed the results. This article summarizes the proceedings of this workshop and background information provided by workshop participants. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. J Biomed Mater Res Part B: Appl Biomater, 105B: 1330-1341, 2017. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
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Kleitman, Naomi; Rao, Mahendra S; Owens, David F
2013-07-01
Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts.
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Kleitman, Naomi; Owens, David F.
2013-01-01
Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts. PMID:23757505
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205..., 2013. ADDRESSES: You may submit comments, identified by Docket No. FDA-2012- N-1205, by any of the... Docket No. FDA-2012-N-1205. All comments received may be posted [[Page 17935
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002...: The Food and Drug Administration (FDA) is announcing a public workshop regarding the design of... information (including name, title, firm name, address, telephone, and fax number) to [email protected]fda.hhs...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001..., HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing... name, address, telephone, and fax number) to [email protected]fda.hhs.gov . Persons without access to the...
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76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-30
...] Medical Device Epidemiology Network 2011: Second Annual Public Workshop AGENCY: Food and Drug... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second Annual Public... and solicit feedback on the establishment of a network that works with FDA experts to determine the...
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75 FR 34463 - Oversight of Laboratory Developed Tests; Public Meeting; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-17
.../default.htm . Online registration is available until 5 p.m. on July 12, 2010. Persons without Internet access may call Katherine Serrano at 301-796-6652 by July 12, 2010, to register for the meeting. Early... be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences...
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76 FR 42715 - Quarantine Release Errors in Blood Establishments; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-19
... Committee on Blood Safety and Availability (the Committee) met to discuss the current FDA blood donor...] Quarantine Release Errors in Blood Establishments; Public Workshop AGENCY: Food and Drug Administration, HHS... entitled: ``Quarantine Release Errors in Blood Establishments.'' The purpose of this public workshop is to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT); Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration...
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76 FR 45271 - Review and Qualification of Clinical Outcome Assessments; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-28
... announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for... appropriate drug development program. Because the qualification process is separate from the drug marketing... other DDTs. This workshop will focus on FDA review principles specific to all type of COAs, i.e., PRO...
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78 FR 18611 - Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-27
...] Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for Comments AGENCY: Food and...: The Food and Drug Administration (FDA) and cosponsor International Color Consortium (ICC) are announcing the following public workshop entitled ``Summit on Color in Medical Imaging: An International...
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Behrsing, Holger; Hill, Erin; Raabe, Hans; Tice, Raymond; Fitzpatrick, Suzanne; Devlin, Robert; Pinkerton, Kent; Oberdörster, Günter; Wright, Chris; Wieczorek, Roman; Aufderheide, Michaela; Steiner, Sandro; Krebs, Tobias; Asgharian, Bahman; Corley, Richard; Oldham, Michael; Adamson, Jason; Li, Xiang; Rahman, Irfan; Grego, Sonia; Chu, Pei-Hsuan; McCullough, Shaun; Curren, Rodger
2017-07-01
In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. Specific topics were covered to assess the status of current in vitro smoke and aerosol/vapour exposure systems, as well as the various approaches and challenges to quantifying the complex exposures in in vitro pulmonary models developed for evaluating adverse pulmonary events resulting from tobacco product exposures. The four core topics covered were: a) Tobacco Smoke and E-Cigarette Aerosols; b) Air-Liquid Interface-In Vitro Exposure Systems; c) Dosimetry Approaches for Particles and Vapours/In Vitro Dosimetry Determinations; and d) Exposure Microenvironment/Physiology of Cells. The 2.5-day workshop included presentations from 20 expert speakers, poster sessions, networking discussions, and breakout sessions which identified key findings and provided recommendations to advance these technologies. Here, we will report on the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapour exposures. With the recent FDA publication of the final deeming rule for the governance of tobacco products, there is an unprecedented necessity to evaluate a very large number of tobacco-based products and ingredients. The questionable relevance, high cost, and ethical considerations for the use of in vivo testing methods highlight the necessity of robust in vitro approaches to elucidate tobacco-based exposures and how they may lead to pulmonary diseases that contribute to lung exposure-induced mortality worldwide. 2017 FRAME.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-06
... scientific workshop. In addition, FDA is aware that dengue viruses are endemic in Quintana Roo and Jalisco. FDA is currently evaluating the risk of dengue virus infections in U.S. blood donors that are acquired...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-23
...] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility... experience or expertise with nanotechnology. There will be a limited number of round-table participants. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The...
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Food and Drug Administration workshop on indirect mechanisms of carcinogenesis.
Poirier, L A
1996-01-01
A workshop sponsored by the Food and Drug Administration (FDA) was held on March 4-5, 1996, at the Lister Hill Auditorium of the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop considered both the scientific aspects and the regulatory implications of indirect-acting carcinogens. A wide variety of agents and of prospective mechanisms was discussed. The organizing committee for the workshop consisted of Drs. James Farrelly and Joseph DeGeorge of the Center for Drug Evaluation and Research (CDER), Ronald J. Lorentzen and Sidney Green of the Center for Food Safety and Applied Nutrition (CFSAN), Martin D. Green of the Center for Biologics, Evaluation and Research (CBER), C. Darnell Jackson and Lionel A. Poirier of the National Center for Toxicological Research (NCTR). Rosalie K. Elespuru of the Center for Devices and Radiological Health (CDRH), and David G. Longfellow of the National Cancer Institute (NCI). Following an introduction by Dr. Poirier, who provided a description of indirect carcinogens, the major talks were grouped into three formal sessions: indirect-acting compounds and agents of FDA interest, biological and biochemical endpoints commonly seen with indirect agents, and specific problems associated with the indirect-acting compounds. A panel discussion followed and the concluding remarks were made by Dr. Bernard A. Schwetz, Associate Commissioner for Science, FDA.
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Duan, J; Kesisoglou, F; Novakovic, J; Amidon, GL; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R
2017-01-01
On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.”1 The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole‐body framework.2 PMID:28571121
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... Internet access, please contact Jay Crowley (see Contact Person) to register. Registration requests should... lodging, and other relevant information on the Internet at http://www.fda.gov/UDI . Comments: Regardless... Sentinel Initiative, on the Internet at http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm...
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Medical Device Plug-and-Play Interoperability Standards and Technology Leadership
2014-10-01
downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDRH /CDRHReports/UCM391521.pdf. Dr. Goldman spoke in multiple panels at this workshop...downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTo bacco/ CDRH /CDRHReports/UCM391521.pdf Arney D, Plourde J, Schrenker R, Mattegunta P
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Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection
Tummers, Willemieke S.; Warram, Jason M.; Tipirneni, Kiranya E.; Fengler, John; Jacobs, Paula; Shankar, Lalitha; Henderson, Lori; Ballard, Betsy; Pogue, Brian W.; Weichert, Jamey P.; Bouvet, Michael; Sorger, Jonathan; Contag, Christopher H.; Frangioni, John V.; Tweedle, Michael F.; Basilion, James P.; Gambhir, Sanjiv S.; Rosenthal, Eben L.
2017-01-01
Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process. This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. PMID:28428283
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Abel, Dorothy B; Beebe, Hugh G; Dedashtian, Mark M; Morton, Michael C; Moynahan, Megan; Smith, Loius J; Weinberg, Steven L
2002-05-01
Since their introduction into clinical trials in the United States, endovascular aortic grafts have shown various types of problems. Although details of design and construction vary between different endovascular grafts and failure modes have had a variety of causes and clinical effects, the inability of preclinical testing to predict these failures remains common to all endovascular grafts. The need to improve preclinical testing in an attempt to reduce clinical device failures resulted in a Food and Drug Administration-sponsored workshop on endovascular graft preclinical testing held in Rockville, Md, from July 31 to August 1, 2001. FORMAT: The workshop was not designed as a consensus conference. Instead, it provided a forum for bringing stakeholders together to define problems and identify areas of agreement and disagreement. The workshop had 34 invited participants who represented device manufacturers, the medical community, the Food and Drug Administration, and testing facilities, and international attendance was more than 120 people. Discussion centered on: 1, defining the physiologic, anatomic, and morphologic characteristics of abdominal aortic aneurysms before and after endovascular graft treatment; 2, identifying the types of failures that have been observed clinically; and 3, determining which characteristics should be considered during preclinical modeling to better predict clinical performance. Attendees agreed to the need to better define and address anatomic characteristics and changes in the aneurysm after endograft treatment to optimize preclinical testing. Much discussion and little agreement occurred on the importance of flow-related forces on graft performance or the need or ability to define and model physiologic compliance during durability testing. The discussion and conclusions are summarized in this paper and are provided in detail at: http://www.fda.gov/cdrh/meetings/073101workshop.html. The workshop raised awareness of significant performance issues and the challenges of modeling the extremely variable and relatively undefined environment of abdominal aortic aneurysms. Through the interactive format of the workshop, participants identified areas of preclinical testing, device design, and aspects of the simulated environment that need further consideration.
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Bower, Joseph; Fast, Douglas; Garofolo, Fabio; Gouty, Dominique; Hayes, Roger; Lowes, Steve; Nicholson, Robert; LeLacheur, Richard; Bravo, Jennifer; Shoup, Ronald; Dumont, Isabelle; Carbone, Mary; Zimmer, Jennifer; Ortuno, Jordi; Caturla, Maria Cruz; Datin, Jim; Lansing, Tim; Fatmi, Saadya; Struwe, Petra; Sheldon, Curtis; Islam, Rafiqul; Yu, Mathilde; Hulse, Jim; Kamerud, John; Lin, John; Doughty, John; Kurylak, Kai; Tang, Daniel; Buonarati, Mike; Blanchette, Alexandre; Levesque, Ann; Gagnon-Carignan, Sofi; Lin, Jenny; Ray, Gene; Liu, Yanseng; Khan, Masood; Xu, Allan; El-Sulayman, Gibran; DiMarco, Chantal; Bouhajib, Mohammed; Tacey, Dick; Jenkins, Rand; der Strate, Barry van; Briscoe, Chad; Karnik, Shane; Rhyne, Paul; Garofolo, Wei; Schultz, Gary; Roberts, Andrew; Redrup, Mike; DuBey, Ira; Conliffe, Phyllis; Pekol, Teri; Hantash, Jamil; Cojocaru, Laura; Allen, Mike; Reuschel, Scott; Watson, Andrea; Farrell, Colin; Groeber, Elizabeth; Malone, Michele; Nowatzke, William; Fang, Xinping
2014-01-01
The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.
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76 FR 20690 - International Consortium of Orthopedic Registries; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
... orthopedic implant information and create a research network to advance the methodology and conduct of research related to orthopedic device performance. Date and Time: The public workshop will be held on May 9... discussion among FDA and international orthopedic registries and develop a research consortium (ICOR) that...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0547] Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments AGENCY: Food and... clinically meaningful (e.g., subjective and objective assessments of memory, recall, anxiety, agitation, or...
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77 FR 43604 - National Institute of Allergy and Infectious Diseases (NIAID); Notice of Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-25
... Infectious Diseases (NIAID), a component of the National Institutes of Health; the Food and Drug Administration (FDA); the Transformational Medical Technologies (TMT); and Biomedical Advanced Research and... for drugs; 21 CFR 601.90 for biological products). The goals of this workshop are to highlight the...
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Ginsberg, Barry H.; Klonoff, David C.; Crabtree, Vincent P.
2017-01-01
On July 6 and 7, 2016 the Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies was held on the National Institutes of Health (NIH) Campus at the Lister Hill Auditorium. The meeting was sponsored by a group of governmental organizations and NGOs, listed in Appendix A. This was a very timely meeting as the artificial pancreas appears to be growing from academic studies to commercial projects. The first artificial pancreas may be marketed within 12 months and a few may be approved within 24 months. The NIH, the FDA, the JDRF, Helmsley Trust, Diabetes Technology Society, and other agencies, funders, and organizations have been strongly supportive of advancing artificial pancreas technology and usability, and thus the proceedings from this conference should be of exceptional interest to the diabetes technology community. PMID:28349709
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Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection.
Tummers, Willemieke S; Warram, Jason M; Tipirneni, Kiranya E; Fengler, John; Jacobs, Paula; Shankar, Lalitha; Henderson, Lori; Ballard, Betsy; Pogue, Brian W; Weichert, Jamey P; Bouvet, Michael; Sorger, Jonathan; Contag, Christopher H; Frangioni, John V; Tweedle, Michael F; Basilion, James P; Gambhir, Sanjiv S; Rosenthal, Eben L
2017-05-01
Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process. This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. Cancer Res; 77(9); 2197-206. ©2017 AACR . ©2017 American Association for Cancer Research.
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Zhang, X; Duan, J; Kesisoglou, F; Novakovic, J; Amidon, G L; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R
2017-08-01
On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
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Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA
Gallas, Brandon D.; Chan, Heang-Ping; D’Orsi, Carl J.; Dodd, Lori E.; Giger, Maryellen L.; Gur, David; Krupinski, Elizabeth A.; Metz, Charles E.; Myers, Kyle J.; Obuchowski, Nancy A.; Sahiner, Berkman; Toledano, Alicia Y.; Zuley, Margarita L.
2017-01-01
This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance. PMID:22306064
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0690] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-08
... investigators, regulators, manufacturers, patients, caregivers, and advocacy groups. Where gaps in our knowledge... with CNCP. FDA will be considering the following questions during the workshop: 1. What is currently... pharmaceuticals chronically for the treatment of pain? 3. What is known regarding use of pain biomarkers (e.g...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-24
... in the diagnosis of leukemia and lymphoma and more recently in the detection of minimal residual... chronic lymphocytic leukemia (CLL); (3) Third-party flow cytometry data analysis software; and (4... held February 27, 2013 (77 FR 76051, December 26, 2012). An FDA workshop for acute lymphocytic leukemia...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1073] Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-03
... Drug Evaluation and Research,Food and Drug Administration, Office of Antimicrobial Products, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food...
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Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D
2007-01-01
Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-24
... enhancements to extend the model predictions from red blood cell units to other blood components, such as...] Use of Computer Simulation of the United States Blood Supply in Support of Planning for Emergency...: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-20
... telephone number. Those without Internet access should contact Maureen Dreher or Erica Takai to register... participants will be sent technical system requirements after registration and will be sent connection access... approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-14
...; Change of Meeting Location AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing a change in location for the upcoming public workshop... notice a new location. II. New Location for the Public Workshop The new location will be the Holiday Inn...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-24
... health industry that submits new animal drug applications to CVM's Office of New Animal Drug Evaluation... agreed to in the Animal Drug User Fee Amendments (ADUFA II) of 2008 ( http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm044941.htm ). The ONADE will be soliciting feedback on both the e...
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Brain-computer interface devices for patients with paralysis and amputation: a meeting report
NASA Astrophysics Data System (ADS)
Bowsher, K.; Civillico, E. F.; Coburn, J.; Collinger, J.; Contreras-Vidal, J. L.; Denison, T.; Donoghue, J.; French, J.; Getzoff, N.; Hochberg, L. R.; Hoffmann, M.; Judy, J.; Kleitman, N.; Knaack, G.; Krauthamer, V.; Ludwig, K.; Moynahan, M.; Pancrazio, J. J.; Peckham, P. H.; Pena, C.; Pinto, V.; Ryan, T.; Saha, D.; Scharen, H.; Shermer, S.; Skodacek, K.; Takmakov, P.; Tyler, D.; Vasudevan, S.; Wachrathit, K.; Weber, D.; Welle, C. G.; Ye, M.
2016-04-01
Objective. The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. For innovative devices involving brain-computer interfaces, this is particularly important. Approach. Towards this goal, on 21 November, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of brain-computer interface (BCI) devices, defined for the purposes of this workshop as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. Main results. This paper summarizes the presentations and discussions from that workshop. Significance. CDRH plans to use this information to develop regulatory considerations that will promote innovation while maintaining appropriate patient protections. FDA plans to build on advances in regulatory science and input provided in this workshop to develop guidance that provides recommendations for premarket submissions for BCI devices. These proceedings will be a resource for the BCI community during the development of medical devices for consumers.
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Brain-computer interface devices for patients with paralysis and amputation: a meeting report.
Bowsher, K; Civillico, E F; Coburn, J; Collinger, J; Contreras-Vidal, J L; Denison, T; Donoghue, J; French, J; Getzoff, N; Hochberg, L R; Hoffmann, M; Judy, J; Kleitman, N; Knaack, G; Krauthamer, V; Ludwig, K; Moynahan, M; Pancrazio, J J; Peckham, P H; Pena, C; Pinto, V; Ryan, T; Saha, D; Scharen, H; Shermer, S; Skodacek, K; Takmakov, P; Tyler, D; Vasudevan, S; Wachrathit, K; Weber, D; Welle, C G; Ye, M
2016-04-01
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. For innovative devices involving brain-computer interfaces, this is particularly important. Towards this goal, on 21 November, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of brain-computer interface (BCI) devices, defined for the purposes of this workshop as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. This paper summarizes the presentations and discussions from that workshop. CDRH plans to use this information to develop regulatory considerations that will promote innovation while maintaining appropriate patient protections. FDA plans to build on advances in regulatory science and input provided in this workshop to develop guidance that provides recommendations for premarket submissions for BCI devices. These proceedings will be a resource for the BCI community during the development of medical devices for consumers.
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Lesko, Lawrence J; Salerno, Ronald A; Spear, Brian B; Anderson, Donald C; Anderson, Timothy; Brazell, Celia; Collins, Jerry; Dorner, Andrew; Essayan, David; Gomez-Mancilla, Baltazar; Hackett, Joseph; Huang, Shiew-Mei; Ide, Susan; Killinger, Joanne; Leighton, John; Mansfield, Elizabeth; Meyer, Robert; Ryan, Stephen G; Schmith, Virginia; Shaw, Peter; Sistare, Frank; Watson, Mark; Worobec, Alexandra
2003-04-01
The use of pharmacogenetics and pharmacogenomics in the drug development process, and in the assessment of such data submitted to regulatory agencies by industry, has generated significant enthusiasm as well as important reservations within the scientific and medical communities. This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory "safe harbor" for exploratory genome-based data, and to provide a forum for industry-regulatory agency dialogue on these important issues.
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A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves.
Yoganathan, Ajit P; Fogel, Mark; Gamble, Susan; Morton, Michael; Schmidt, Paul; Secunda, Jeff; Vidmar, Sara; Del Nido, Pedro
2013-10-01
Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication. In stark contrast to the various designs of adult-sized replacement valves available in the market, there are no Food and Drug Administration (FDA)-approved prosthetic heart valves available for use in the pediatric population. There is a pressing need for FDA-approved pediatric valve devices in the United States. The pediatric patient population has been typically excluded from replacement heart valve trials for several reasons. In January 2010, heart valve manufacturers and pediatric clinicians collaborated with academicians and FDA staff in a workshop to suggest ways to successfully evaluate pediatric prosthetic valves and conduct pediatric clinical trials to provide acceptable heart valve replacement options for this patient population. Recommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing. The article specifically addresses in vitro and premarket and postmarket approval clinical studies that should be considered by a heart valve manufacturer for obtaining regulatory approval of pediatric sizes of prosthetic heart valve designs that are already approved for adult clinical use. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
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Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G
2015-06-01
Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.
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76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-12
... p.m. on September 9, 2011. For those without Internet access, please call the contact person to... will be posted, as it becomes available, on the Internet at http://www.fda.gov/MedicalDevices/News...
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Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
Wang, J; Johnson, T; Sahin, L; Tassinari, MS; Anderson, PO; Baker, TE; Bucci-Rechtweg, C; Burckart, GJ; Chambers, CD; Hale, TW; Johnson-Lyles, D; Nelson, RM; Nguyen, C; Pica-Branco, D; Ren, Z; Sachs, H; Sauberan, J; Zajicek, A; Ito, S; Yao, LP
2017-01-01
This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants. PMID:28510297
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NASA Astrophysics Data System (ADS)
Baleanu, Dumitru; Tenreiro Machado, J. A.
2009-10-01
The international workshop, Fractional Differentiation and its Applications (FDA08), held at Cankaya University, Ankara, Turkey on 5-7 November 2008, was the third in an ongoing series of conferences dedicated to exploring applications of fractional calculus in science, engineering, economics and finance. Fractional calculus, which deals with derivatives and integrals of any order, is now recognized as playing an important role in modeling multi-scale problems that span a wide range of time or length scales. Fractional calculus provides a natural link to the intermediate-order dynamics that often reflects the complexity of micro- and nanostructures through fractional-order differential equations. Unlike the more established techniques of mathematical physics, the methods of fractional differentiation are still under development; while it is true that the ideas of fractional calculus are as old as the classical integer-order differential operators, modern work is proceeding by both expanding the capabilities of this mathematical tool and by widening its range of applications. Hence, the interested reader will find papers here that focus on the underlying mathematics of fractional calculus, that extend fractional-order operators into new domains, and that apply well established methods to experimental and theoretical problems. The organizing committee invited presentations from experts representing the international community of scholars in fractional calculus and welcomed contributions from the growing number of researchers who are applying fractional differentiation to complex technical problems. The selection of papers in this topical issue of Physica Scripta reflects the success of the FDA08 workshop, with the emergence of a variety of novel areas of application. With these ideas in mind, the guest editors would like to honor the many distinguished scientists that have promoted the development of fractional calculus and, in particular, Professor George M Zaslavsky who supported this special issue but passed away recently. The organizing committee wishes to thank the sponsors and supporters of FDA08, namely Cankaya University represented by the President of the Board of Trustees Sitki Alp and Rector Professor Ziya B Güvenc, The Scientfic and Technological Research Council of Turkey (TUBITAK) and the IFAC for providing the resources needed to hold the workshop, the invited speakers for sharing their expertise and knowledge of fractional calculus, and the participants for their enthusiastic contributions to the discussions and debates.
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Summary of breakout session f: facility and equipment decontamination strategies.
Norwood, Laurie P; Suvarna, Kalavati
2011-01-01
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-07
...] Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals; Public...), in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum on Medical Device Reporting, Complaint Files, and Recalls...
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King, Kathryn; Wiebe, Michael
2011-01-01
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).
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77 FR 52746 - Medical Countermeasures for a Burn Mass Casualty Incident
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-30
... telephone number. Those without Internet access should contact Suzanne Schwartz to register (see Contact... will be sent technical system requirements after registration and will be sent connection access... Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm . (Select this...
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Behrsing, Holger; Raabe, Hans; Manuppello, Joseph; Bombick, Betsy; Curren, Rodger; Sullivan, Kristie; Sethi, Sanjay; Phipps, Richard; Tesfaigzi, Yohannes; Yan, Sherwin; D'Ruiz, Carl; Tarran, Robert; Constant, Samuel; Phillips, Gary; Gaça, Marianna; Hayden, Patrick; Cao, Xuefei; Mathis, Carole; Hoeng, Julia; Braun, Armin; Hill, Erin
2016-05-01
The Family Smoking Prevention and Tobacco Control Act of 2009 established the Food and Drug Administration Center for Tobacco Products (FDA-CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current in vitro technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular, the progression of chronic obstructive pulmonary disease (COPD). The four topics covered were: a) Inflammation and Oxidative Stress; b) Ciliary Dysfunction and Ion Transport; c) Goblet Cell Hyperplasia and Mucus Production; and d) Parenchymal/Bronchial Tissue Destruction and Remodelling. The 2.5 day workshop included 18 expert speakers, plus poster sessions, networking and breakout sessions, which identified key findings and provided recommendations to advance the in vitro technologies and assays used to evaluate tobacco-induced disease etiologies. The workshop summary was reported at the 2015 Society of Toxicology Annual Meeting, and the recommendations led to an IIVS-organised technical workshop in June 2015, entitled Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays, to assess these assays and to conduct a proof-of-principle multi-laboratory exercise to determine their suitability for standardisation. Here, we report on the proceedings, recommendations and outcomes of the December 2014 workshop, including paths forward to continue the development of non-animal methods to evaluate tissue responses that model the disease processes that may lead to COPD, a major cause of mortality worldwide. 2016 FRAME.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-03
... determine endpoints; questionnaire design and analyses; and presentation of survey results. To date, FDA has..., the workshop will invest considerable time in identifying best methodological practices for conducting... sample, sample size, question design, process, and endpoints. Panel 2 will focus on alternatives to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD... patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
... gaps in existing knowledge regarding equianalgesic opioid conversion in clinical practice, to develop a... organization as well as the total number of participants based on space limitations. Registrants will receive... be based on space availability. If registration reaches maximum capacity, FDA will post a notice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-11
... and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing a public..., patient advocates, patients, and clinicians on how to identify sound, quantitative outcome measures that.... Contact Persons: Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...
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78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-11
...: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration...
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SYNOPSIS: The question of how tissues and organs are shaped during development is crucial for understanding human birth defects. Data from high-throughput screening assays on human stem cells may be utilized predict developmental toxicity with reasonable accuracy. Other types of ...
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Frame, James N.; Jacobson, Joseph O.; Vogel, Wendy H.; Griffith, Niesha; Wariabharaj, Darshan; Garg, Rekha; Zon, Robin; Stephens, Cyntha L.; Bialecki, Alison M.; Bruinooge, Suanna S.; Allen, Steven L.
2013-01-01
To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder presentations and topical panel discussions addressed REMS program development, implementation processes, and practice experiences, as well as oncology drug safety processes. A draft REMS decision tool prepared by the ASCO REMS Steering Committee was presented for group discussion with facilitated, goal-oriented feedback. The workshop identified several unintended consequences resulting from current oncology REMS: (1) the release of personal health information to drug sponsors as a condition for gaining access to a needed drug; (2) risk information that is not tailored—and therefore not accessible—to all literacy levels; (3) exclusive focus on drug risk, thereby affecting patient-provider treatment discussion; (4) REMS elements that do not consider existing, widely practiced oncology safety standards, professional training, and experience; and (5) administrative burdens that divert the health care team from direct patient care activities and, in some cases, could limit patient access to important therapies. Increased provider and professional society participation should form the basis of ongoing and future REMS standardization discussions with the FDA to work toward overall improvement of risk communication. PMID:23814522
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-15
... Accountability Office, Food and Drug Administration: Response to Heparin Contamination Helped Protect Public... obtain approval from the Food & Drug Administration (``FDA'') pursuant to an abbreviated regulatory pathway established by the Hatch-Waxman Act.\\1\\ \\1\\ See The Federal Food, Drug, and Cosmetic Act, 21 U.S.C...
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Report from the National Institute of Allergy and Infectious Disease Workshop on Drug Allergy
Wheatley, Lisa M; Plaut, Marshall; Schwaninger, Julie M; Banerji, Aleena; Castells, Mariana; Finkelman, Fred D.; Gleich, Gerald J.; Guttman-Yassky, Emma; Mallal, Simon A.K.; Naisbitt, Dean J.; Ostrov, David A.; Phillips, Elizabeth J.; Pichler, Werner J.; Platts-Mills, Thomas A. E.; Roujeau, Jean-Claude; Schwartz, Lawrence B.; Trepanier, Lauren A.
2015-01-01
Allergic reactions to drugs are a serious public health concern. In 2013, the National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology and Transplantation, sponsored a workshop on drug allergy. International experts in the field of drug allergy with backgrounds in allergy, immunology, infectious diseases, dermatology, clinical pharmacology and pharmacogenomics discussed the current state of drug allergy research. These experts were joined by representatives from several NIH Institutes and the U.S. Food and Drug Administration (FDA). The participants identified important advances that make new research directions feasible and made suggestions for research priorities and for development of infrastructure to advance our knowledge of the mechanisms, diagnosis, management, and prevention of drug allergy. The workshop summary and recommendations are presented herein. PMID:26254053
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-21
...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...
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In 2009, the passing of The Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP) and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed “...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-30
... Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...
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21 CFR 1270.21 - Determination of donor suitability for human tissue intended for transplantation.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 2 (e.g., FDA licensed screening test for anti-HIV-2); (3) Hepatitis B (e.g., FDA licensed screening test for HBsAg); and (4) Hepatitis C (e.g., FDA licensed screening test for anti-HCV). (b) In the case... been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and...
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21 CFR 1270.21 - Determination of donor suitability for human tissue intended for transplantation.
Code of Federal Regulations, 2012 CFR
2012-04-01
... virus, Type 1 (e.g., FDA licensed screening test for anti-HIV-1); (2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed screening test for anti-HIV-2); (3) Hepatitis B (e.g., FDA licensed screening... been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and...
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21 CFR 1270.21 - Determination of donor suitability for human tissue intended for transplantation.
Code of Federal Regulations, 2014 CFR
2014-04-01
... virus, Type 1 (e.g., FDA licensed screening test for anti-HIV-1); (2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed screening test for anti-HIV-2); (3) Hepatitis B (e.g., FDA licensed screening... been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and...
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21 CFR 1270.21 - Determination of donor suitability for human tissue intended for transplantation.
Code of Federal Regulations, 2011 CFR
2011-04-01
... virus, Type 1 (e.g., FDA licensed screening test for anti-HIV-1); (2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed screening test for anti-HIV-2); (3) Hepatitis B (e.g., FDA licensed screening... been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and...
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21 CFR 1270.21 - Determination of donor suitability for human tissue intended for transplantation.
Code of Federal Regulations, 2013 CFR
2013-04-01
... virus, Type 1 (e.g., FDA licensed screening test for anti-HIV-1); (2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed screening test for anti-HIV-2); (3) Hepatitis B (e.g., FDA licensed screening... been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and...
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Komlos, D
2015-07-01
Nearly 400 professionals attended the 2-day Generic Pharmaceutical Association (GPhA) workshop dedicated to fostering discussions on the FDA's chemistry, manufacturing and controls (CMC) expectations for abbreviated new drug applications (ANDAs), enhanced regulatory filing requirements, and other topics, as CMC takes root in the Office of Pharmaceutical Quality (OPQ). Following the keynote address by Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research (CDER) and Acting Director of OPQ, and an update from the Office of Generic Drugs (OGD) by Ted Sherwood, Acting Director of the OGD's Office of Regulatory Operations, plenary sessions took place covering OPQ updates, management plans, Generic Drug User Fee Amendments of 2012 (GDUFA) backlog, year 1 and 2 cohorts, drug substance, defining starting materials, quality related refuse-to-receive standards, risk and team-based integrated quality assessment, deficiencies and information requests - CMC submissions, emerging technologies, compliance and inspection, lifecycle management of drug products, quality metrics, pharmaceutically relevant dissolution specifications, and communication and project management. This report will provide a summary of conference highlights. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.
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Pazdur, Richard; Abrams, Jeffrey S.; Socinski, Mark A.; Sause, William T.; Harpole, David H.; Welch, John J.; Korn, Edward L.; Ullmann, Claudio Dansky; Hirsch, Fred R.
2014-01-01
On February 2, 2012, the National Cancer Institute (NCI) sponsored a 2-day workshop with the NCI Thoracic Malignancies Steering Committee and the Food and Drug Administration to bring together leading academicians, clinicians, industry and government representatives to identify challenges and potential solutions in the clinical development of novel targeted therapies for lung cancer. Measures of success are rapidly evolving from a scientific and regulatory perspective and the objectives of this workshop were to achieve initial consensus on a high priority biomarker-driven clinical trial designed to rapidly assess the activity of targeted agents in molecularly defined lung cancer subsets and to facilitate generation of data leading to approval of these new therapies. Additionally, the meeting focused on identification of the barriers to conduct such a trial and the development of strategies to overcome those barriers. The “Lung Master Protocols” recently launched by NCI were the direct outcome of this workshop. PMID:25521397
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Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.
Yim, Seon-Hee; Chung, Yeun-Jun
2014-12-01
In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.
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In Vitro Exposure Systems and Dosimetry Assessment Tools ...
In 2009, the passing of The Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP) and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed “modified risk”. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference titled “In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products” to bring together stakeholders representing regulatory agencies, academia, and industry to address the research priorities articulated by the FDA CTP. Specific topics were covered to assess the status of current in vitro smoke and aerosol/vapor exposure systems, as well as the various approaches and challenges to quantifying the complex exposures, in in vitro pulmonary models developed for evaluating adverse pulmonary events resulting from tobacco product exposures. The four core topics covered were, 1) Tobacco Smoke And E-Cigarette Aerosols, 2) Air-Liquid Interface-In Vitro Exposure Systems, 3) Dosimetry Approaches For Particles And Vapors; In Vitro Dosimetry Determinations and 4) Exposure Microenvironment/Physiology Of Cells. The two and a half day workshop included presentations from 20 expert speakers, poster sessions, networking discussions, and breakout sessions which identified key findings and provided recommendations to advance these technologies. Here, we will re
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-31
... Safety Testing of Sunlamp Products'' Form FDA 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' Form FDA 3633''General Variance Request'' Form FDA 3634 ``Television Products Annual Report'' Form FDA 3635 ``Laser Light Show Notification'' Form FDA 3636 ``Guide for Preparing...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-12
... Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products'' FDA Form 3637...
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Theory and practice of conventional adventitious virus testing.
Gregersen, Jens-Peter
2011-01-01
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) For decades conventional tests in cell cultures and in laboratory animals have served as standard methods for broad-spectrum screening for adventitious viruses. New virus detection methods based on molecular biology have broadened and improved our knowledge about potential contaminating viruses and about the suitability of the conventional test methods. This paper summarizes and discusses practical aspects of conventional test schemes, such as detectability of various viruses, questionable or false-positive results, animal numbers needed, time and cost of testing, and applicability for rapidly changing starting materials. Strategies to improve the virus safety of biological medicinal products are proposed. The strategies should be based upon a flexible application of existing and new methods along with a scientifically based risk assessment. However, testing alone does not guarantee the absence of adventitious agents and must be accompanied by virus removing or virus inactivating process steps for critical starting materials, raw materials, and for the drug product.
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Challenges and opportunities in RSV vaccine development: Meeting report from FDA/NIH workshop.
Roberts, Jeffrey N; Graham, Barney S; Karron, Ruth A; Munoz, Flor M; Falsey, Ann R; Anderson, Larry J; Marshall, V; Kim, Sonnie; Beeler, Judy A
2016-09-22
Respiratory syncytial virus (RSV) is the most common cause of serious acute lower respiratory illness in infants and young children and a significant cause of disease burden in the elderly and immunocompromised. There are no licensed RSV vaccines to address this significant public health need. While advances in vaccine technologies have led to a recent resurgence in RSV vaccine development, the immune correlates of protection against RSV and the immunology of vaccine-associated enhanced respiratory disease (ERD) remain poorly understood. FDA's Center for Biologics Evaluation and Research (CBER) and NIH's National Institute of Allergy and Infectious Diseases (NIAID) organized and co-sponsored an RSV Vaccines Workshop in Bethesda, Maryland on June 1 and 2, 2015. The goal of the conference was to convene scientists, regulators, and industry stakeholders to discuss approaches to RSV vaccine development within the context of three target populations - infants and children, pregnant women, and individuals >60years of age. The agenda included topics related to RSV vaccine development in general, as well as considerations specific to each target population, such as clinical and serological endpoints. The meeting focused on vaccine development for high income countries (HIC), because issues relevant to vaccine development for low and middle income countries (LMIC) have been discussed in other forums. This manuscript summarizes the discussion of clinical, scientific, and regulatory perspectives, research gaps, and lessons learned. Copyright © 2016.
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Urogynecologic Surgical Mesh Implants
... FDA collected samples during the inspections, and reviewed mechanical performance testing and sterility testing of the final ... characterization of the polypropylene resin, and biocompatibility and mechanical performance testing on the final product. The FDA ...
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NASA Astrophysics Data System (ADS)
Park, Sangwook; Lee, Young-Ran; Hwang, Yoola; Javier Santiago Noguero Galilea
2009-12-01
This paper describes the Flight Dynamics Automation (FDA) system for COMS Flight Dynamics System (FDS) and its test result in terms of the performance of the automation jobs. FDA controls the flight dynamics functions such as orbit determination, orbit prediction, event prediction, and fuel accounting. The designed FDA is independent from the specific characteristics which are defined by spacecraft manufacturer or specific satellite missions. Therefore, FDA could easily links its autonomous job control functions to any satellite mission control system with some interface modification. By adding autonomous system along with flight dynamics system, it decreases the operator’s tedious and repeated jobs but increase the usability and reliability of the system. Therefore, FDA is used to improve the completeness of whole mission control system’s quality. The FDA is applied to the real flight dynamics system of a geostationary satellite, COMS and the experimental test is performed. The experimental result shows the stability and reliability of the mission control operations through the automatic job control.
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Price, performance, and the FDA approval process: the example of home HIV testing.
Paltiel, A David; Pollack, Harold A
2010-01-01
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.
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HIV Testing in the United States
... health facilities ;” May 2007. ← Return to text FDA Consumer Information, “Fourth Generation HIV Diagnostic Test Approved, permitting ... HIV): Screening; ” April 2013. ← Return to text FDA Consumer Information, “First rapid diagnostic test to detect both ...
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Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
Caliendo, Angela M; Hanson, Kimberly E
2016-04-01
Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.
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Tahara, Hideaki; Sato, Marimo; Thurin, Magdalena; Wang, Ena; Butterfield, Lisa H; Disis, Mary L; Fox, Bernard A; Lee, Peter P; Khleif, Samir N; Wigginton, Jon M; Ambs, Stefan; Akutsu, Yasunori; Chaussabel, Damien; Doki, Yuichiro; Eremin, Oleg; Fridman, Wolf Hervé; Hirohashi, Yoshihiko; Imai, Kohzoh; Jacobson, James; Jinushi, Masahisa; Kanamoto, Akira; Kashani-Sabet, Mohammed; Kato, Kazunori; Kawakami, Yutaka; Kirkwood, John M; Kleen, Thomas O; Lehmann, Paul V; Liotta, Lance; Lotze, Michael T; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Matsubara, Hisahiro; Mayrand-Chung, Shawmarie; Nakamura, Kiminori; Nishikawa, Hiroyoshi; Palucka, A Karolina; Petricoin, Emanuel F; Pos, Zoltan; Ribas, Antoni; Rivoltini, Licia; Sato, Noriyuki; Shiku, Hiroshi; Slingluff, Craig L; Streicher, Howard; Stroncek, David F; Takeuchi, Hiroya; Toyota, Minoru; Wada, Hisashi; Wu, Xifeng; Wulfkuhle, Julia; Yaguchi, Tomonori; Zeskind, Benjamin; Zhao, Yingdong; Zocca, Mai-Britt; Marincola, Francesco M
2009-01-01
Supported by the Office of International Affairs, National Cancer Institute (NCI), the "US-Japan Workshop on Immunological Biomarkers in Oncology" was held in March 2009. The workshop was related to a task force launched by the International Society for the Biological Therapy of Cancer (iSBTc) and the United States Food and Drug Administration (FDA) to identify strategies for biomarker discovery and validation in the field of biotherapy. The effort will culminate on October 28th 2009 in the "iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer", which will be held in Washington DC in association with the Annual Meeting. The purposes of the US-Japan workshop were a) to discuss novel approaches to enhance the discovery of predictive and/or prognostic markers in cancer immunotherapy; b) to define the state of the science in biomarker discovery and validation. The participation of Japanese and US scientists provided the opportunity to identify shared or discordant themes across the distinct immune genetic background and the diverse prevalence of disease between the two Nations. Converging concepts were identified: enhanced knowledge of interferon-related pathways was found to be central to the understanding of immune-mediated tissue-specific destruction (TSD) of which tumor rejection is a representative facet. Although the expression of interferon-stimulated genes (ISGs) likely mediates the inflammatory process leading to tumor rejection, it is insufficient by itself and the associated mechanisms need to be identified. It is likely that adaptive immune responses play a broader role in tumor rejection than those strictly related to their antigen-specificity; likely, their primary role is to trigger an acute and tissue-specific inflammatory response at the tumor site that leads to rejection upon recruitment of additional innate and adaptive immune mechanisms. Other candidate systemic and/or tissue-specific biomarkers were recognized that might be added to the list of known entities applicable in immunotherapy trials. The need for a systematic approach to biomarker discovery that takes advantage of powerful high-throughput technologies was recognized; it was clear from the current state of the science that immunotherapy is still in a discovery phase and only a few of the current biomarkers warrant extensive validation. It was, finally, clear that, while current technologies have almost limitless potential, inadequate study design, limited standardization and cross-validation among laboratories and suboptimal comparability of data remain major road blocks. The institution of an interactive consortium for high throughput molecular monitoring of clinical trials with voluntary participation might provide cost-effective solutions. PMID:19534815
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Standards for Lithotripter Performance
NASA Astrophysics Data System (ADS)
Schultheiss, Reiner; Doerffel, Michael
2008-09-01
Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.
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Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony
The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-30
...] Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and... Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... their complexity, the FDA is considering standardizing stability testing policies by adopting...
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Zeukeng, Minette-Joëlle; Seoane-Vazquez, Enrique; Bonnabry, Pascal
2018-06-01
This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x 2 -tests were performed for the analysis. From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant. The indications approved by the FDA, the EMA, and SMC for the same drugs were similar in content for 23.1% drugs and different in 76.9% of the drugs. Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC. There were differences in the characteristics of new drugs approved by the EMA, the FDA, and SMC in the period 2007-2016. Overall, two thirds of the new drugs were first approved by the FDA. Differences in indications were found in three out of four new drugs approved by the three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new drugs approved by different agencies persist.
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1995-02-01
The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.
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FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.
Wilson, Carolyn A; Simonyan, Vahan
2014-01-01
Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and bioinformatics tools to be able to store and analyze large amounts of data. To address this need, we have developed the High-performance Integrated Virtual Environment, or HIVE. HIVE uses a combination of distributed cloud storage and distributed cloud computations to provide a platform that is both rapid and responsive to support the growing and increasingly diverse scientific and regulatory needs of FDA scientists in their evaluation of NGS in research and ultimately for evaluation of NGS data in regulatory submissions. © PDA, Inc. 2014.
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2005 Donor Eligibility Requirements: Unintended Consequences for Stem Cell Development.
Couture, Larry A; Carpenter, Melissa K
2015-10-01
Several human embryonic stem cell (hESC)-derived cell therapeutics have entered clinical testing and more are in various stages of preclinical development. The U.S. Food and Drug Administration (FDA) regulates these products under existing regulations and has stated that these products do not constitute a new class of biologic. However, as human tissue, hESCs are subject to regulations that were developed before hESCs were first described. The regulations have not been revised since 2005, well before the first hESC-derived product entered clinical studies. The current regulations require donors of hESCs to be tested in the same manner as donors of tissues intended for transplantation. However, because hESC-derived cell products are more than minimally manipulated, they are also subject to the same end-of-production release testing as most other biologic agents. In effect, this makes hESC products subject to redundant testing. No other biologic is subject to a similar testing requirement. Furthermore, the regulations that require donor testing are specifically applicable to hESC cells harvested from donors after a date in 2005. It is unclear which regulations cover hESCs harvested before 2005. Ambiguity in the guidelines and redundant testing requirements have unintentionally created a burdensome regulatory paradigm for these products and reluctance on the part of developers to invest in these promising therapeutics. We propose a simple solution that would address FDA safety concerns, eliminate regulatory uncertainty and risk, and provide flexibility for the FDA in the regulation of hESC-derived cell therapies. Regulatory ambiguity concerning donor eligibility screening and testing requirements for human embryonic stem cell lines, in particular those lines created before 2005, are causing significant concern for drug developers. Technically, most of these lines fail to meet eligibility under U.S. Food and Drug Administration (FDA) rules for product licensure, and many developers are unaware that FDA approval to begin trials under an exemption is not an assurance that the FDA will grant licensure of the product. This Perspective outlines the ambiguity and the problem it has caused and proposes a workable solution. The intent is to generate stakeholder and FDA discussion on this issue. ©AlphaMed Press.
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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2015-05-22
The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.
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Fault detection and accommodation testing on an F100 engine in an F-15 airplane
NASA Technical Reports Server (NTRS)
Myers, L. P.; Baer-Riedhart, J. L.; Maxwell, M. D.
1985-01-01
The fault detection and accommodation (FDA) methodology for digital engine-control systems may range from simple comparisons of redundant parameters to the more complex and sophisticated observer models of the entire engine system. Evaluations of the various FDA schemes are done using analytical methods, simulation, and limited-altitude-facility testing. Flight testing of the FDA logic has been minimal because of the difficulty of inducing realistic faults in flight. A flight program was conducted to evaluate the fault detection and accommodation capability of a digital electronic engine control in an F-15 aircraft. The objective of the flight program was to induce selected faults and evaluate the resulting actions of the digital engine controller. Comparisons were made between the flight results and predictions. Several anomalies were found in flight and during the ground test. Simulation results showed that the inducement of dual pressure failures was not feasible since the FDA logic was not designed to accommodate these types of failures.
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Practicing safe cell culture: applied process designs for minimizing virus contamination risk.
Kiss, Robert D
2011-01-01
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Genentech responded to a virus contamination in its biologics manufacturing facility by developing and implementing a series of barriers specifically designed to prevent recurrence of this significant and impactful event. The barriers included steps to inactivate or remove potential virus particles from the many raw materials used in cell culture processing. Additionally, analytical testing barriers provided protection of the downstream processing areas should a culture contamination occur, and robust virus clearance capability provided further assurance of virus safety should a low level contamination go undetected. This conference proceeding will review Genentech's approach, and lessons learned, in minimizing virus contamination risk in cell culture processes through multiple layers of targeted barriers designed to deliver biologics products with high success rates.
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An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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Schlaberg, Robert; Mitchell, Michael J; Taggart, Edward W; She, Rosemary C
2012-01-01
US Food and Drug Administration (FDA)-approved diagnostic tests based on molecular genetic technologies are becoming available for an increasing number of microbial pathogens. Advances in technology and lower costs have moved molecular diagnostic tests formerly performed for research purposes only into much wider use in clinical microbiology laboratories. To provide an example of laboratory studies performed to verify the performance of an FDA-approved assay for the detection of Clostridium difficile cytotoxin B compared with the manufacturer's performance standards. We describe the process and protocols used by a laboratory for verification of an FDA-approved assay, assess data from the verification studies, and implement the assay after verification. Performance data from the verification studies conducted by the laboratory were consistent with the manufacturer's performance standards and the assay was implemented into the laboratory's test menu. Verification studies are required for FDA-approved diagnostic assays prior to use in patient care. Laboratories should develop a standardized approach to verification studies that can be adapted and applied to different types of assays. We describe the verification of an FDA-approved real-time polymerase chain reaction assay for the detection of a toxin gene in a bacterial pathogen.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0259... meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing the following.... 4321, Silver Spring, MD 20903, 301-796- 5661, e-mail: [email protected]fda.hhs.gov ; or Zivana Tezak, Food...
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Investigation of the interfacial reaction between metal and fluorine-contained polyimides
NASA Astrophysics Data System (ADS)
Yang, Ching-Yu; Chen, J. S.; Hsu, S. L. C.
2005-07-01
In this work, thin metal films (Cr and Ta) were deposited on fluorine-contained polyimides, 6FDA-BisAAF, and 6FDA-PPD. The chemical states of the metal/polyimide samples were characterized by using x-ray photoelectron spectroscopy (XPS). XPS analysis reveals that metal-C, C-O, and metal-O bondings are present in metallized 6FDA-BisAAF and 6FDA-PPD. C-F bonds are observed in bare 6FDA-BisAAF and 6FDA-PPD however, they are not seen in the metallized samples. Disappearance of the C-F bonding is attributed to the disruption of CF3 side groups from the main chains of 6FDA-BisAAF and 6FDA-PPD when the chains are exposed to the plasma during the metal deposition. Nevertheless, the disruption of CF3 side groups also creates sites for the formation of metal-C or C-O bondings, which provide a positive adhesion strength at the metal/polyimide interface, as revealed by the tape test.
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The Use of Test Results from ASA Workshops to Evaluate Workshop Effectiveness
ERIC Educational Resources Information Center
Donegan, Judith H.; And Others
1976-01-01
Results of test given to participants in six American Society of Anesthesiologists workshops were analyzed to determine whether attendance increased scores on sequential tests (before, immediately after, and three months later). Both workshop and control groups of anesthesiologists increased their scores with each successive test. (Editor/JT)
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... and HIV Diagnostic Assays HIV (Human Immunodeficiency Virus) Consumer Information for Patients & Patient Advocates Contact FDA (800) ... 4709 (240) 402-8010 ocod@fda.hhs.gov Consumer Affairs Branch (CBER) Division of Communication and Consumer ...
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Integrating pharmacogenomics into pharmacy practice via medication therapy management.
Reiss, Susan M
2011-01-01
To explore the application and integration of pharmacogenomics in pharmacy clinical practice via medication therapy management (MTM) to improve patient care. Department of Health & Human Services (HHS) Personalized Health Care Initiative, Food and Drug Administration (FDA) pharmacogenomics activity, and findings from the Utilizing E-Prescribing Technologies to Integrate Pharmacogenomics into Prescribing and Dispensing Practices Stakeholder Workshop, convened by the American Pharmacists Association (APhA) on March 5, 2009. Participants at the Stakeholder Workshop included diverse representatives from pharmacy, medicine, pathology, health information technology (HIT), standards, science, academia, government, and others with a key interest in the clinical application of pharmacogenomics. In 2006, HHS initiated the Personalized Health Care Initiative with the goal of building the foundation for the delivery of gene-based care, which may prove to be more effective for large patient subpopulations. In the years since the initiative was launched, drug manufacturers and FDA have begun to incorporate pharmacogenomic data and applications of this information into the drug development, labeling, and approval processes. New applications and processes for using this emerging pharmacogenomics data are needed to effectively integrate this information into clinical practice. Building from the findings of a stakeholder workshop convened by APhA and the advancement of the pharmacist's collaborative role in patient care through MTM, emerging roles for pharmacists using pharmacogenomic information to improve patient care are taking hold. Realizing the potential role of the pharmacist in pharmacogenomics through MTM will require connectivity of pharmacists into the electronic health record infrastructure to permit the exchange of pertinent health information among all members of a patient's health care team. Addressing current barriers, concerns, and system limitations and developing an effective infrastructure will be necessary for pharmacogenomics to achieve its true potential. To achieve integration of pharmacogenomics into clinical practice via MTM, the pharmacy profession must define a process for the application of pharmacogenomic data into pharmacy clinical practice that is aligned with MTM service delivery, develop a viable business model for these practices, and encourage and direct the development of HIT solutions that support the pharmacist's role in this emerging field.
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Kahl, Brad S; Gordon, Leo I; Dreyling, Martin; Gascoyne, Randy D; Sotomayor, Eduardo M
2015-01-01
Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma characterized by the t(11;14) chromosomal translocation and cyclin D1 over-expression. A biologically and clinically heterogeneous lymphoma, MCL, remains clinically challenging, with no proven curative therapy and no established standard of care. However, there have been considerable advances in the last several years in the treatment and understanding of MCL with the FDA approval of lenalidomide and ibrutinib, the development of other potentially active novel agents and the identification of recurrent mutations through new genomic sequencing approaches that may contribute to the biology of MCL and to therapeutic resistance. At the Lymphoma Research Foundation's 11th MCL Workshop, researchers gathered to discuss recent studies and current issues related to the biology of MCL, novel therapeutic targets and new treatment strategies. The presentations are summarized in this manuscript, which is intended to highlight areas of active investigation and identify topics for future research.
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Alqahtani, Saad; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Eguale, Tewodros
2015-07-01
The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed. Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies. Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products. Copyright © 2015 John Wiley & Sons, Ltd.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... Products, Questions and Answers.'' Because of increases in the number and complexity of ANDAs and FDA's...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances....'' Because of increases in the number and complexity of ANDAs and FDA's desire to standardize generic drug...
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Caliendo, Angela M; Couturier, Marc R; Ginocchio, Christine C; Hanson, Kimberly E; Miller, Melissa B; Walker, Kimberly E; Frank, Gregory M
2016-07-15
In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.
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2000-04-07
The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.
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NASA Astrophysics Data System (ADS)
Wagner, Robert F.; Beiden, Sergey V.; Campbell, Gregory; Metz, Charles E.; Sacks, William M.
2003-05-01
The dialog among investigators in academia, industry, NIH, and the FDA has grown in recent years on topics of historic interest to attendees of these SPIE sub-conferences on Image Perception, Observer Performance, and Technology Assessment. Several of the most visible issues in this regard have been the emergence of digital mammography and modalities for computer-assisted detection and diagnosis in breast and lung imaging. These issues appear to be only the "tip of the iceberg" foreshadowing a number of emerging advances in imaging technology. So it is timely to make some general remarks looking back and looking ahead at the landscape (or seascape). The advances have been facilitated and documented in several forums. The major role of the SPIE Medical Imaging Conferences i well-known to all of us. Many of us were also present at the Medical Image Perception Society and co-sponsored by CDRH and NCI in September of 2001 at Airlie House, VA. The workshops and discussions held at that conference addressed some critical contemporary issues related to how society - and in particular industry and FDA - approach the general assessment problem. A great deal of inspiration for these discussions was also drawn from several workshops in recent years sponsored by the Biomedical Imaging Program of the National Cancer Institute on these issues, in particular the problem of "The Moving Target" of imaging technology. Another critical phenomenon deserving our attention is the fact that the Fourth National Forum on Biomedical Imaging in Oncology was recently held in Bethesda, MD., February 6-7, 2003. These forums are presented by the National Cancer Institute (NCI), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the National Electrical Manufacturers Association (NEMA). They are sponsored by the National Institutes of Health/Foundation for Advanced Education in the Sciences (NIH/FAES). These forums led to the development of the NCI"s Interagency Council on Biomedical Imaging in Oncology (ICBIO) about two and a half years ago. The purpose of the ICBIO is to assist developers of new imaging technologies for cancer screening and diagnosis to find a coherent way to interface with government agencies with responsibilities in these areas. A recent product of these activities was an overview paper written by the present authors and published this year in the Journal Academic Radiology (2). The paper includes a summary of some of the major developments in assessment methodology in recent years and includes several case studies from the public forum of the FDA"s Center for Devices & Radiological Health (CDRH). We will include a brief sketch of some of the key issues of that paper in this review.
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The teratology testing of food additives.
Barrow, Paul C; Spézia, François
2013-01-01
The developmental and reproductive toxicity testing (including teratogenicity) of new foods and food additives is performed worldwide according to the guidelines given in the FDA Redbook. These studies are not required for substances that are generally recognized as safe, according to the FDA inventory. The anticipated cumulated human exposure level above which developmental or reproduction studies are required depends on the structure-alert category. For food additives of concern, both developmental (prenatal) and reproduction (multigeneration) studies are required. The developmental studies are performed in two species, usually the rat and the rabbit. The reproduction study is generally performed in the rat. The two rat studies are preferably combined into a single experimental design, if possible. The test methods described in the FDA Redbook are similar to those specified by the OECD for the reproductive toxicity testing of chemicals.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-19
... will provide a better understanding of target audiences that FDA will need in order to design effective... evaluative research, it will allow FDA to ascertain the effectiveness of the messages and the distribution...
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Senior, John R
2014-11-01
Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began to show serious and sometimes fatal liver toxicity, we began at the Food and Drug Administration (FDA) a series of annual conferences in 1999 to consider issues of drug-induced liver injury (DILI). First inviting reviewers of new drug applications we opened the audiences in 2001 to pharmaceutical industry and academic consultants to industry and FDA, and slides shown at the meetings were posted on the internet to be available at the website of the American Association for the Study of Liver Diseases (AASLD)-go to ( http://www.aasld.org/dili/Pages/default.aspx ). Observations by Dr. Hyman J. Zimmerman that "drug-induced hepatocellular jaundice is a serious lesion" with possible mortality formed a basis for developing a computer program to plot peak serum values for alanine aminotransferase (ALT) and total bilirubin (TBL) in an x-y log-log graph for all subjects enrolled in clinical trials. This program had the capability to show the time course of all liver tests for individuals who had both hepatocellular injury and reduced whole liver function, plus clinical narratives to diagnose the severity and most likely cause of the abnormalities. We called the program eDISH (for evaluation of Drug-Induced Serious Hepatotoxicity), and began in 2004 to use it to assess DILI in clinical trial subjects. From 2008, comments made by the presenters at the conferences about their slides and ensuing discussions have been added to the website. All this has raised awareness of the problem, and since 1997, the FDA has not had to withdraw a single drug because of post-marketing hepatotoxicity. Many issues still remain to be resolved; among the most controversial is the best method to estimate likelihood that a given liver injury was actually caused by the drug in question. On November 9, 2012, a workshop was convened to discuss the best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.
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Lerner, Seth P.; Bajorin, Dean F.; Dinney, Colin P.; Efstathiou, Jason A.; Groshen, Susan; Hahn, Noah M.; Hansel, Donna; Kwiatkowski, David; O’Donnell, Michael; Rosenberg, Jonathan; Svatek, Robert; Abrams, Jeffrey S.; Al-Ahmadie, Hikmat; Apolo, Andrea B.; Bellmunt, Joaquim; Callahan, Margaret; Cha, Eugene K.; Drake, Charles; Jarow, Jonathan; Kamat, Ashish; Kim, William; Knowles, Margaret; Mann, Bhupinder; Marchionni, Luigi; McConkey, David; McShane, Lisa; Ramirez, Nilsa; Sharabi, Andrew; Sharpe, Arlene H.; Solit, David; Tangen, Catherine M.; Amiri, Abdul Tawab; Van Allen, Eliezer; West, Pamela J.; Witjes, J. A.; Quale, Diane Zipursky
2016-01-01
The NCI Bladder Cancer Task Force convened a Clinical Trials Planning Meeting (CTPM) Workshop focused on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer (NMIBC). Meeting attendees included a broad and multi-disciplinary group of clinical and research stakeholders and included leaders from NCI, FDA, National Clinical Trials Network (NCTN), advocacy and the pharmaceutical and biotech industry. The meeting goals and objectives were to: 1) create a collaborative environment in which the greater bladder research community can pursue future optimally designed novel clinical trials focused on the theme of molecular targeted and immune-based therapies in NMIBC; 2) frame the clinical and translational questions that are of highest priority; and 3) develop two clinical trial designs focusing on immunotherapy and molecular targeted therapy. Despite successful development and implementation of large Phase II and Phase III trials in bladder and upper urinary tract cancers, there are no active and accruing trials in the NMIBC space within the NCTN. Disappointingly, there has been only one new FDA approved drug (Valrubicin) in any bladder cancer disease state since 1998. Although genomic-based data for bladder cancer are increasingly available, translating these discoveries into practice changing treatment is still to come. Recently, major efforts in defining the genomic characteristics of NMIBC have been achieved. Aligned with these data is the growing number of targeted therapy agents approved and/or in development in other organ site cancers and the multiple similarities of bladder cancer with molecular subtypes in these other cancers. Additionally, although bladder cancer is one of the more immunogenic tumors, some tumors have the ability to attenuate or eliminate host immune responses. Two trial concepts emerged from the meeting including a window of opportunity trial (Phase 0) testing an FGFR3 inhibitor and a second multi-arm multi-stage trial testing combinations of BCG or radiotherapy and immunomodulatory agents in patients who recur after induction BCG (BCG failure). PMID:27376138
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NASA Astrophysics Data System (ADS)
2004-06-01
JULY 2004 2nd World Congress of the Game Theory Society, Faculty of Luminy, Marseille, France 5-9 July 2004 Europa Organisation (europa@europa-organisation.com), +33 5 34 45 26 45, www.gts2004.org Budapest Workshop on Behavioral Economics, Central European University, Budapest, Hungary 5-10 July 2004 Eva Dotzi (behavecon@ceu.hu), www.iza.org/en/calls_conferences/CallCEU_04.pdf FDA'04. 1st IFAC Workshop on Fractional Differentiation and its Applications, Bordeaux, France 19-20 July 2004 IFAC secretariat (fda04@lap.u-bordeaux1.fr), www.lap.u-bordeaux.fr/fda04/ Bachelier Finance Society Third World Congress, InterContinental Hotel, Chicago, IL, USA 21-24 July 2004 bfs2004@uic.edu, www.uic.edu/orgs/bachelier/ BS/IMS 2004. 6th World Congress of the Bernoulli Society for Mathematical Statistics and Probability, Barcelona, Spain 26-31 July 2004 wc2004@pacifico-meetings.com, +34 93 402 13 85, www.imub.ub.es/events/wc2004 AUGUST 2004 Summer School in Econometrics. The Cointegrated VAR Model: Econometric Methodology and Macroeconomic Applications, Institute of Economics, University of Copenhagen, Denmark 2-22 August 2004 Summerschool@econ.ku.dk, www.econ.ku.dk/summerschool SEPTEMBER 2004 First Bonzenfreies Colloquium on Market Dynamics and Quantitative Economics, Alessandria, Palazzo Borsalino, Italy 9-10 September 2004 colloquium@unipmn.it, www.mfn.unipmn.it/~colloqui/ Risk Analysis 2004. 4th International Conference on Computer Simulation in Risk Analysis and Hazard Mitigation, Aldemar Paradise Royal Mare Hotel, Rhodes, Greece 27-29 September 2004 enquiries@wessex.ac.uk, +44 (0)238 029 3223, www.wessex.ac.uk/conferences/2004/risk04/ OCTOBER 2004 IRC Hedge 2004, InterContinental Hotel, London, UK 10, 11 October 2004 enquiries@irc-conferences.com, www.irc-conferences.com/show_conference.php?id=10 NOVEMBER 2004 IRC DICE 2004, InterContinental Hotel, London, UK 22, 23 November 2004 enquiries@irc-conferences.com, www.irc-conferences.com/show_conference.php?id=13 DECEMBER 2004 Quantitative Methods in Finance 2004, Sydney, Australia 15-18 December 2004 Andrea Schnaufer (qmf@uts.edu.au), +61 2 9514 7737, www.business.uts.edu.au/finance/resources/qmf2004/ JANUARY 2005 Developments in Quantitative Finance, Isaac Newton Institute for Mathematical Sciences, Cambridge, UK 24 January-22 July 2005 www.newton.cam.ac.uk/programmes/DQF/index.html
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The effect of short-term workshop on improving clinical reasoning skill of medical students
Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader
2016-01-01
Background: Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. Methods: This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. Results: The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Conclusion: Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students. PMID:27579286
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The effect of short-term workshop on improving clinical reasoning skill of medical students.
Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader
2016-01-01
Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students.
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Alternative methods to determine headwater benefits
DOE Office of Scientific and Technical Information (OSTI.GOV)
Bao, Y.S.; Perlack, R.D.; Sale, M.J.
1997-11-10
In 1992, the Federal Energy Regulatory Commission (FERC) began using a Flow Duration Analysis (FDA) methodology to assess headwater benefits in river basins where use of the Headwater Benefits Energy Gains (HWBEG) model may not result in significant improvements in modeling accuracy. The purpose of this study is to validate the accuracy and appropriateness of the FDA method for determining energy gains in less complex basins. This report presents the results of Oak Ridge National Laboratory`s (ORNL`s) validation of the FDA method. The validation is based on a comparison of energy gains using the FDA method with energy gains calculatedmore » using the MWBEG model. Comparisons of energy gains are made on a daily and monthly basis for a complex river basin (the Alabama River Basin) and a basin that is considered relatively simple hydrologically (the Stanislaus River Basin). In addition to validating the FDA method, ORNL was asked to suggest refinements and improvements to the FDA method. Refinements and improvements to the FDA method were carried out using the James River Basin as a test case.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-17
... quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. The CPG... practices regulation (21 CFR 10.115). The CPG represents FDA's current thinking on the criteria for direct...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-20
... is issued: (1) All cows from which import milk or cream is produced must be physically examined and found healthy; (2) if the milk or cream is imported raw, all such cows must pass a tuberculin test; (3... farms. 1210.12 FDA 1995/Physical 1 1 1 0.5 0.5 examination of cows. 1210.13 FDA 1994/Tuberculin test...
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Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection
Chollet, John L.; Jozwiakowski, Michael J.
2012-01-01
The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865
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DOT National Transportation Integrated Search
2016-10-14
Milestones Since Last Workshop - Finalized GPS/GNSS receiver test plan and test procedures - Coordinated government and manufacturer participation and executed Non-Disclosure Agreements (NDAs) - Developed/validated radiated RF test environment - Carr...
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Self-assessed efficacy of a clinical musculoskeletal anatomy workshop: A preliminary survey.
Saavedra, Miguel Ángel; Navarro-Zarza, José E; Alvarez-Nemegyei, José; Canoso, Juan J; Kalish, Robert A; Villaseñor-Ovies, Pablo; Hernández-Díaz, Cristina
2015-01-01
To survey the efficacy of a practical workshop on clinical musculoskeletal anatomy held in five American countries. A self-assessment competence questionnaire sent to participants 1-3 months after the workshop. Results were compared to the results of a practical, instructor-assessed, pre-workshop test. The response rate of participants was 76.4%. The overall, self-assessed competence score for anatomical items that had been included in the pre-test was 76.9 (scale 0-100) as compared to an overall score of 48.1 in the practical, pre-workshop test (p<0.001). For items that were addressed in the workshop, but not included in the pre-test, self-assessed competence was rated at 62.9. Differences in anatomical knowledge between individuals from different countries and professional groups noted in the practical pre-test were no longer present in the post-test self-assessment. From this preliminary data and supporting evidence from the literature we believe that our anatomy workshop provides an effective didactic tool for increasing competence in musculoskeletal anatomy. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
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High Fidelity Drug Repurposing, Molecular Profiling, and Cell Reprogramming
2016-09-01
network pharmacology and CRCs) to discover and test repurposed drugs that target PCa on an individual patient basis. Objective 1: We will enrich the FDA...repurposing”, for all FDA-approved and experimental drugs. We have recently integrated our proprietary TMFS with network pharmacology , which will help to...samples. In this proposal we integrate two paradigm-shifting Georgetown-Lombardi technologies (TMFS/network pharmacology and CRCs) to discover and test
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-27
... valid import milk permit (21 U.S.C. 141). Before such permit is issued: (1) All cows from which import... imported raw, all such cows must pass a tuberculin test; (3) the dairy farm and each plant in which the... examination of cows. 1210.13....... FDA 1994/ 1 1 1 0.5 0.5 Tuberculin test. 1210.14....... FDA 1997/ 2 1 2 2...
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"The Google of Healthcare": enabling the privatization of genetic bio/databanking.
Spector-Bagdady, Kayte
2016-07-01
23andMe is back on the market as the first direct-to-consumer genetic testing company that "includes reports that meet Food and Drug Administration (FDA) standards…." But, whereas its front-end product is selling individual genetic tests online, its back-end business model is amassing one of the largest privately owned genetic databases in the world. What is the effect, however, of the private control of bio/databases on genetic epidemiology and public health research? The recent federal government notices of proposed rulemaking for: (1) revisions to regulations governing human subjects research and (2) whether certain direct-to-consumer genetic tests should require premarket FDA review, were reviewed and related to the 23andMe product, business model, and consumer agreements. FDA regulatory action so far has focused on the return of consumer test reports but it should also consider the broader misuse of data and information not otherwise protected by human subjects research regulations. As the federal government revises its decades-old human subjects research structure, the Executive Office of the President (EOP) should consider a cohesive approach to regulating private genetic bio/databanks. This strategy should allow the FDA and other agencies to play a role in expanding current regulatory coverage. Copyright © 2016 Elsevier Inc. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-13
... audiences that FDA needs to design effective communication strategies, messages, and labels. These... group settings. Third, as evaluative research, it will allow FDA to ascertain the effectiveness of the... include contractor expenses for designing and conducting information collection activities, specifically...
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Shrivastava, Manisha; Shah, Nehal; Navaid, Seema
2018-01-01
In an era of evidence based medicine research is an essential part of medical profession whether clinical or academic. A research methodology workshop intends to help participants, those who are newer to research field or those who are already doing empirical research. The present study was conducted to assess the changes in knowledge of the participants of a research methodology workshop through a structured questionnaire. With administrative and ethical approval, a four day research methodology workshop was planned. The participants were subjected to a structured questionnaire (pre-test) containing 20 multiple choice questions (Q1-Q 20) related to the topics to be covered in research methodology workshop before the commencement of the workshop and then subjected to similar posttest questionnaire after the completion of workshop. The mean values of pre and post-test scores were calculated and the results were analyzed and compared. Out of the total 153 delegates, 45(29 %) were males and 108 were (71 %) females. 92 (60%) participants consented to fill the pre-test questionnaire and 68 (44%) filled the post-test questionnaire. The mean Pre-test and post-test scores at 95% Confidence Interval were 07.62 (SD ±3.220) and 09.66 (SD ±2.477) respectively. The differences were found to be significant using Paired Sample T test ( P <0.003). There was increase in knowledge of the delegates after attending research methodology workshops. Participatory research methodology workshops are good methods of imparting knowledge, also the long term effects needs to be evaluated.
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A United States regulator's perspective on the ongoing chlorofluorocarbon transition.
Meyer, R J
1999-12-01
The Food and Drug Administration (FDA) put in place a general ban on the use of chlorofluorocarbons for the products it regulates (medical devices, drugs, and foods) in 1978, exempting those products where chlorofluorocarbon use was determined to be essential for the public health. In the intervening years, as the international commitment to a full transition away from all chlorofluorocarbon use took shape under the Montreal Protocol, the FDA has worked with industry to facilitate the development and testing of alternative technologies and products for inhalation drug products. As these alternative products begin to move from testing through the approval process and into marketing, the FDA is working collaboratively with the Environmental Protection Agency, other governmental agencies, and nongovernmental stakeholders to develop a transition policy for the United States. The transition policy for metered dose inhalers must be one that achieves the dual aims of first protecting the patients who rely on these vital medical products, while also achieving the public health need of protecting the ozone layer. As a part of developing such a transition strategy, the FDA published an advance notice of proposed rulemaking (ANPRM) in March 1997. The ANPRM proposed mechanisms by which the FDA could determine when chlorofluorocarbon use in a drug product could no longer be considered essential. The ANPRM resulted in a large amount of valuable public debate and input. The FDA is now working to incorporate the knowledge gained from these public comments as it continues the rule-making process.
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33 CFR 157.12f - Workshop functional test requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12f Workshop functional test requirements... the specific design of equipment. A completed workshop certificate including the delivery test... several ppm values on all measurement scales when operated on an oil appropriate for the application of...
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33 CFR 157.12f - Workshop functional test requirements.
Code of Federal Regulations, 2011 CFR
2011-07-01
... CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12f Workshop functional test requirements... the specific design of equipment. A completed workshop certificate including the delivery test... several ppm values on all measurement scales when operated on an oil appropriate for the application of...
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Digital electronic engine control fault detection and accommodation flight evaluation
NASA Technical Reports Server (NTRS)
Baer-Ruedhart, J. L.
1984-01-01
The capabilities and performance of various fault detection and accommodation (FDA) schemes in existing and projected engine control systems were investigated. Flight tests of the digital electronic engine control (DEEC) in an F-15 aircraft show discrepancies between flight results and predictions based on simulation and altitude testing. The FDA methodology and logic in the DEEC system, and the results of the flight failures which occurred to date are described.
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Evaluation of efficacy of heartworm preventive products at the FDA.
Hampshire, Victoria A
2005-10-24
The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian or pet-owner's call to them. Under the present regulations, canine heartworm preventatives are approved for 100% efficacy after testing in laboratory and field conditions. The report of lack of efficacy against heartworm larvae is a serious adverse drug event because the resulting condition or the treatment of the condition is life threatening. Information on lack of effect that are deemed possibly, probably, or definitely drug-related available for review under generic product on the FDA/CVM website Surveillance of these reports indicates there are some failures for virtually all heartworm prevention product categories. Most failures have been reported in heartworm-endemic states. At this time, it is unclear whether these are representative of the rare occurrences of failure that have been in existence for a long time, but not reported regularly or promptly, or whether there is a true increase in complaints of ineffectiveness and real variability between products. This paper discusses methods, personnel, and procedures in place in the Division of Surveillance that will aid the FDA to better assess heartworm preventive treatment failures. It discusses scoring paradigms presently utilized by FDA/CVM to assess severity of complaints of lack of efficacy against heartworms, and welcomes audience input as to how to improve existing processes. Results suggest that more comprehensive reporting will provide FDA/CVM more accurate surveillance information regarding efficacy problems. Such practices will permit FDA/CVM to better interpret both incidence and severity of in-effect and possible patterns of emerging resistance and to convey this in any necessary updated labeling. It also indicates that as part of that process, practitioners should return to a more conservative testing schedule.
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2007-06-25
The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.
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High-Speed Research: 1994 Sonic Boom Workshop. Configuration, Design, Analysis and Testing
NASA Technical Reports Server (NTRS)
McCurdy, David A. (Editor)
1999-01-01
The third High-Speed Research Sonic Boom Workshop was held at NASA Langley Research Center on June 1-3, 1994. The purpose of this workshop was to provide a forum for Government, industry, and university participants to present and discuss progress in their research. The workshop was organized into sessions dealing with atmospheric propagation; acceptability studies; and configuration design, and testing. Attendance at the workshop was by invitation only. The workshop proceedings include papers on design, analysis, and testing of low-boom high-speed civil transport configurations and experimental techniques for measuring sonic booms. Significant progress is noted in these areas in the time since the previous workshop a year earlier. The papers include preliminary results of sonic boom wind tunnel tests conducted during 1993 and 1994 on several low-boom designs. Results of a mission performance analysis of all low-boom designs are also included. Two experimental methods for measuring near-field signatures of airplanes in flight are reported.
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NASA Technical Reports Server (NTRS)
Myers, L. P.; Baer-Riedhart, J. L.; Maxwell, M. D.
1985-01-01
The fault detection and accommodation (FDA) methods that can be used for digital engine control systems are presently subjected to a flight test program in the case of the F-15 fighter's F100 engine electronic controls, inducing selected faults and then evaluating the resulting digital engine control responses. In general, flight test results were found to compare well with both ground tests and predictions. It is noted that the inducement of dual-pressure failures was not feasible, since FDA logic was not designed to accommodate them.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-29
...] Advancing the Development of Diagnostic Tests and Biomarkers for Tuberculosis; Public Workshop; Request for... workshop entitled ``Advancing the Development of Diagnostic Tests and Biomarkers for Tuberculosis (TB... Tuberculosis in the United States, Committee on the Elimination of Tuberculosis in the United States, Division...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0333... Requirements for Microbiological Testing and Corrective Measures for Bottled Water AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity...
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FDA's perspectives on cardiovascular devices.
Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G
2009-06-01
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.
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Pelletier, David L
2005-05-01
The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.
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Moore, Thomas J; Furberg, Curt D
2014-01-01
The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.
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Stanger-Hall, Kathrin F.; Shockley, Floyd W.; Wilson, Rachel E.
2011-01-01
We implemented a “how to study” workshop for small groups of students (6–12) for N = 93 consenting students, randomly assigned from a large introductory biology class. The goal of this workshop was to teach students self-regulating techniques with visualization-based exercises as a foundation for learning and critical thinking in two areas: information processing and self-testing. During the workshop, students worked individually or in groups and received immediate feedback on their progress. Here, we describe two individual workshop exercises, report their immediate results, describe students’ reactions (based on the workshop instructors’ experience and student feedback), and report student performance on workshop-related questions on the final exam. Students rated the workshop activities highly and performed significantly better on workshop-related final exam questions than the control groups. This was the case for both lower- and higher-order thinking questions. Student achievement (i.e., grade point average) was significantly correlated with overall final exam performance but not with workshop outcomes. This long-term (10 wk) retention of a self-testing effect across question levels and student achievement is a promising endorsement for future large-scale implementation and further evaluation of this “how to study” workshop as a study support for introductory biology (and other science) students. PMID:21633067
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The nightmare of FDA clearance/approval to market: perception or reality?
Tylenda, C A
1996-09-01
Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.
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Zisblatt, Lara; Hayes, Sean M; Lazure, Patrice; Hardesty, Ilana; White, Julie L; Alford, Daniel P
2017-01-01
Due to the high prevalence of prescription opioid misuse, the US Food and Drug Administration (FDA) mandated a Risk Evaluation and Mitigation Strategy (REMS) requiring manufacturers of extended-release/long-acting (ER/LA) opioids to fund continuing education based on an FDA curricular Blueprint. This paper describes the Safe and Competent Opioid Prescribing Education (SCOPE of Pain) train-the-trainer program and its impact on (1) disseminating the SCOPE of Pain curriculum and (2) knowledge, confidence, attitudes, and performance of the participants of trainer-led compared with expert-led meetings. SCOPE of Pain is a 3-hour ER/LA opioid REMS education. In addition to expert-led live statewide meetings, a 2-hour train-the-trainer (TTT) workshop was developed to increase dissemination nationally. The trainers were expected to conduct SCOPE of Pain meetings at their institutions. Participants of both the trainer-led and expert-led SCOPE of Pain programs were surveyed immediately post and 2 months post meetings to assess improvements in knowledge, confidence, attitudes, and self-reported safe opioid prescribing practices. During 9 months (May 2013 to February 2014), 89 trainers were trained during 9 TTT workshops in 9 states. Over 24 months (May 2013 to April 2015), 33% of the trainers conducted at least 1 SCOPE of Pain training, with a total of 79 meetings that educated 1419 participants. The average number of meetings of those who conducted at least 1 meeting was 2.8 (range: 1-19). The participants of the trainer-led programs were significantly more likely to be practicing in rural settings than those who participated in the expert-led meetings (39% vs. 26%, P < .001). At 2 months post training, there were no significant differences in improvements in participant knowledge, confidence, attitudes, and performance between expert-led and trainer-led meetings. The SCOPE of Pain TTT program holds promise as an effective dissemination strategy to increase guideline-based safe opioid prescribing knowledge, confidence, attitudes, and self-reported practices.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-08
... that accumulate in water column filter- feeding shellfish. Shellfish contaminated with the toxin, if... to collect water and shellfish samples from Federal waters off of southern New England. The FDA, in... ocean quahogs for human consumption. The FDA indicated that testing of clams from the portion of the GB...
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21 CFR 118.8 - Testing methodology for Salmonella Enteritidis (SE).
Code of Federal Regulations, 2010 CFR
2010-04-01
... Salmonella Web site is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm... you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint... Edition, is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalytical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0598... Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...
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O'Brien, Travis J; LeLacheur, Susan; Ward, Caitlin; Lee, Norman H; Callier, Shawneequa; Harralson, Arthur F
2016-03-01
We assessed the impact of personal CYP2D6 testing on physician assistant student competency in, and attitudes toward, pharmacogenetics (PGx). Buccal samples were genotyped for CYP2D6 polymorphisms. Results were discussed during a 3-h PGx workshop. PGx knowledge was assessed by pre- and post-tests. Focus groups assessed the impact of the workshop on attitudes toward the clinical utility of PGx. Both student knowledge of PGx, and its perceived clinical utility, increased immediately following the workshop. However, exposure to PGx on clinical rotations following the workshop seemed to influence student attitudes toward PGx utility. Personal CYP2D6 testing improves both knowledge and comfort with PGx. Continued exposure to PGx concepts is important for transfer of learning.
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Hoffman, Keith B; Dimbil, Mo; Tatonetti, Nicholas P; Kyle, Robert F
2016-06-01
Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug-AE pairs to analyze, the issue of focus is daunting. Our objective was to develop a signaling platform that focuses on AEs with historically demonstrated regulatory interest and to analyze such AEs with a disproportional reporting method that offers broad signal detection and acceptable false-positive rates. We analyzed over 1500 US FDA regulatory actions (safety communications and drug label changes) from 2008 to 2015 to construct a list of eligible signal AEs. The FDA Adverse Event Reporting System (FAERS) was used to evaluate disproportional reporting rates, constrained by minimum case counts and confidence interval limits, of these selected AEs for 109 training drugs. This step led to 45 AEs that appeared to have a low likelihood of being added to a label by FDA, so they were removed from the signal eligible list. We measured disproportional reporting for the final group of eligible AEs on a test group of 29 drugs that were not used in either the eligible list construction or the training steps. In a group of 29 test drugs, our model reduced the number of potential drug-AE signals from 41,834 to 97 and predicted 73 % of individual drug label changes. The model also predicted at least one AE-drug pair label change in 66 % of all the label changes for the test drugs. By concentrating on AE types with already demonstrated interest to FDA, we constructed a signaling system that provided focus regarding drug-AE pairs and suitable accuracy with regard to the issuance of FDA labeling changes. We suggest that focus on historical regulatory actions may increase the utility of pharmacovigilance signaling systems.
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Lead Paint Test Kits Workshop: Summary Report
The U.S. Environmental Protection Agency's (EPA) Office of Research and Development (ORD) designed and conducted the Lead Paint Test Kits Workshop on October 19 and 20, 2006, at the Environmental Protection Agency's Research Triangle Park, NC campus. The workshop was conducted as...
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2011-10-01
Phoenix, and Vitek 2 systems). Discordant results were categorized as very major errors (VME), major errors (ME), and minor errors (mE). DNA sequences...01 OCT 2011 2 . REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE Carbapenem Susceptibility Testing Errors Using Three Automated...FDA standards required for device approval (11). The Vitek 2 method was the only automated susceptibility method in our study that satisfied FDA
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Built-In-Test Equipment Requirements Workshop. Workshop Presentation
1981-08-01
quantitatively evaluated in test. (2) It is necessary to develop the statistical methods that should be used for predicting and confirming of diagnostic...of different performance levels of BIT peacetime and wartime applications, and the corresponding manpower and other support requirements should be...reports. The scope of the workshop involves the areas of require- ments for built-in-test and diagnostics, and the methods of testing to ensure that the
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de Leon, Jose; Spina, Edoardo
2016-01-01
This editorial considers two questions in psychopharmacotherapy: 1) What is needed to market pharmacogenetic tests in the US, since the US appears to lead other countries? and 2) What is needed for US-marketed pharmacogenetic tests to be incorporated by prescribers into long-term practice? US marketing of pharmacogenetic tests requires 1) understanding the pharmacological complexity of drug response, 2) modifying the oversight of non-FDA regulatory agencies, 3) clarifying the FDA's role and 4) promoting innovative marketing. The incorporation of pharmacogenetic tests into long-term practice requires 1) not jeopardizing pharmacogenetic testing by short-sighted marketing of non-validated tests, 2) educating prescribers about benefits, 3) educating patients about limitations and 4) considering the differences between isolated testing and generalized testing incorporating big data.
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Morgan, Simon; Morgan, Andy; Kerr, Rohan; Tapley, Amanda; Magin, Parker
2016-01-01
Abstract Objective To assess the effectiveness of an educational intervention on test-ordering attitudes and intended practice of GP trainees, and any associations between changes in test ordering and trainee characteristics. Design Preworkshop and postworkshop survey of attitudes to test ordering, intended test-ordering practices for 3 clinical scenarios (fatigue, screening, and shoulder pain), and tolerance for uncertainty. Setting Three Australian regional general practice training providers. Participants General practice trainees (N = 167). Intervention A 2-hour workshop session and an online module. Main outcome measures Proportion of trainees who agreed with attitudinal statements before and after the workshop; proportion of trainees who would order tests, mean number of tests ordered, and number of appropriate and inappropriate tests ordered for each scenario before and after the workshop. Results Of 167 trainees, 132 (79.0%) completed both the preworkshop and postworkshop questionnaires. A total of 122 trainees attended the workshop. At baseline, 88.6% thought that tests can harm patients, 84.8% believed overtesting was a problem, 72.0% felt pressured by patients, 52.3% believed that tests would reassure patients, and 50.8% thought that they were less likely to be sued if they ordered tests. There were desirable changes in all attitudes after the workshop. Before the workshop, the mean number of tests that trainees would have ordered was 4.4, 4.8, and 1.5 for the fatigue, screening, and shoulder pain scenarios, respectively. After the workshop there were decreases in the mean number of both appropriate tests (decrease of 0.94) and inappropriate tests (decrease of 0.24) in the fatigue scenario; there was no change in the mean number of appropriate tests and a decrease in inappropriate tests (decrease of 0.76) in the screening scenario; and there was an increase in the proportion of trainees who would appropriately not order tests in the shoulder pain scenario. There were no significant associations between changes in test ordering and trainee demographic characteristics or tolerance for uncertainty subscale scores. Conclusion General practice trainees have conflicting attitudes to test ordering and demonstrate nonrational test ordering in 3 common scenarios. A workshop on rational test ordering led to desirable changes in attitudes and more rational intended test ordering. Our findings inform the development of appropriate educational interventions that address nonrational testing in family medicine. PMID:27629671
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Morgan, Simon; Morgan, Andy; Kerr, Rohan; Tapley, Amanda; Magin, Parker
2016-09-01
To assess the effectiveness of an educational intervention on test-ordering attitudes and intended practice of GP trainees, and any associations between changes in test ordering and trainee characteristics. Preworkshop and postworkshop survey of attitudes to test ordering, intended test-ordering practices for 3 clinical scenarios (fatigue, screening, and shoulder pain), and tolerance for uncertainty. Three Australian regional general practice training providers. General practice trainees (N = 167). A 2-hour workshop session and an online module. Proportion of trainees who agreed with attitudinal statements before and after the workshop; proportion of trainees who would order tests, mean number of tests ordered, and number of appropriate and inappropriate tests ordered for each scenario before and after the workshop. Of 167 trainees, 132 (79.0%) completed both the preworkshop and postworkshop questionnaires. A total of 122 trainees attended the workshop. At baseline, 88.6% thought that tests can harm patients, 84.8% believed overtesting was a problem, 72.0% felt pressured by patients, 52.3% believed that tests would reassure patients, and 50.8% thought that they were less likely to be sued if they ordered tests. There were desirable changes in all attitudes after the workshop. Before the workshop, the mean number of tests that trainees would have ordered was 4.4, 4.8, and 1.5 for the fatigue, screening, and shoulder pain scenarios, respectively. After the workshop there were decreases in the mean number of both appropriate tests (decrease of 0.94) and inappropriate tests (decrease of 0.24) in the fatigue scenario; there was no change in the mean number of appropriate tests and a decrease in inappropriate tests (decrease of 0.76) in the screening scenario; and there was an increase in the proportion of trainees who would appropriately not order tests in the shoulder pain scenario. There were no significant associations between changes in test ordering and trainee demographic characteristics or tolerance for uncertainty subscale scores. General practice trainees have conflicting attitudes to test ordering and demonstrate nonrational test ordering in 3 common scenarios. A workshop on rational test ordering led to desirable changes in attitudes and more rational intended test ordering. Our findings inform the development of appropriate educational interventions that address nonrational testing in family medicine. Copyright© the College of Family Physicians of Canada.
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Bache, Christina; Hoonakker, Marieke; Hendriksen, Coenraad; Buchheit, Karl-Heinz; Spreitzer, Ingo; Montag, Thomas
2012-07-01
The Paul-Ehrlich-Institut (PEI), the Nederlands Vaccin Instituut (NVI) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised the international scientific workshop "Animal free Detection of Pertussis Toxin in Vaccines--Alternatives to the Histamine Sensitisation Test" at the PEI in Langen (Germany) on 09-10 June 2011. Twenty-seven experts (regulators, representatives from national control laboratories, vaccine manufacturers and academia) from 7 countries participated in this workshop. The meeting was triggered by the lack of satisfaction with the current safety testing for acellular pertussis vaccines, the "Histamine Sensitisation Test" (HIST) in mice, and the growing attention for the alternatives under development. The workshop objectives were: a) to review the current status of available alternative methods, b) to discuss the sensitivity that an alternative test needs, c) to plan experiments that allow for comparison of the alternative tests. The results of the workshop are summarised in this meeting report. Copyright © 2012. Published by Elsevier Ltd.. All rights reserved.
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76 FR 12975 - Determination of Regulatory Review Period for Purposes of Patent Extension; CERVARIX
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-09
... in situ; and cervical intraepithelial neoplasia grade 1. Subsequent to this approval, the Patent and... testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for...) from MedImmune, LLC., and the Patent and Trademark Office requested FDA's assistance in determining...
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NASA Astrophysics Data System (ADS)
2004-04-01
MAY 2004 GARP's 3rd Credit & Counterparty Risk Summit, London, UK 21-23 May 2004 Andreas Simou (andreas.simou@garp.com), +44 (0)20 7626 9301, www.garp.com/events/3rdcred IMA Workshop 9: Financial Data Analysis and Applications, University of Minnesota, MN, USA 24-28 May 2004 www.ima.umn.edu/complex/spring/c9.html Global Derivatives & Risk Management 2004, NH Eurobuilding, Madrid, Spain 25-28 May 2004 Aden Watkins, ICBI (awatkins@iirltd.co.uk), +44 (0)20 7915 5198, www.icbi-uk.com/globalderivatives/ WEHIA'04 9th Workshop on Economics and Heterogeneous Interacting Agents, Kyodai-Kaikan, Kyoto, Japan 27-29 May 2004 www.nda.ac.jp/cs/AI/wehia04/ JUNE 2004 Semimartingale Theory and Practice in Finance, Pacific Institute for the Mathematical Sciences, Vancouver, BC, Canada 5-10 June 2004 www.pims.math.ca/birs/workshops/2004/04w5032/ MC2QMC 2004 International Conference on Monte Carlo and Quasi-Monte Carlo Methods, Juan-les-Pins, Côte d'Azur, France 7-10 June 2004 Monique Simonetti (Monique.Simonetti@sophia.inria.fr), +33 4 92 38 78 64, www-sop.inria.fr/omega/MC2QMC2004/ GAIM'04 10th Annual Global Alternative Investment Management Forum, The Beaulieu Centre, Lausanne, Switzerland 8-11 June 2004 +44 (0)20 7915 5103, www.icbi-uk.com/gaim/ 3rd Annual Conference Ri$k Management 2004, Fairmont Hotel, Dubai, United Arab Emirates 12-15 June 2004 www.iirme.com/risk/ 10th Annual Risk USA Congress, Boston, MA, USA 21-24 June 2004 Aristotle Liu (aliu@riskwaters.com), +44 (0)207 484 9700, www.riskusa.com Mannheim Empirical Research Summer School, Mannheim University, Germany 22 June-2 July 2004 oliver@kirchkamp.de, www.sfb504.uni-mannheim.de/merss 9th Annual Conference on Econometric Modelling for Africa, Cape Town, South Africa 30 June-2 July 2004 aesinfo@commerce.uct.ac.za, www.commerce.uct.ac.za/economics/AES2004Conference/ 4th Congress of Nonlinear Analysts. Special Session on Mathematical Methods in Theoretical Finance, Hyatt Grand Cypress Resort, Orlando, FL, USA 30 June-7 July 2004 dkermani@fit.edu, +1 321 674 7412, http://kermani.math.fit.edu/ JULY 2004 2nd World Congress of the Game Theory Society, Faculty of Luminy, Marseille, France 5-9 July 2004 Europa Organisation (europa@europa-organisation.com), +33 5 34 45 26 45, www.gts2004.org Budapest Workshop on Behavioral Economics, Central European University, Budapest, Hungary 5-10 July 2004 Eva Dotzi (behavecon@ceu.hu), www.iza.org/en/calls_conferences/CallCEU_04.pdf FDA'04 1st IFAC Workshop on Fractional Differentiation and its Applications, Bordeaux, France 19-20 July 2004 IFAC secretariat (fda04@lap.u-bordeaux1.fr), www.lap.u-bordeaux.fr/fda04/ Bachelier Finance Society Third World Congress, InterContinental Hotel, Chicago, IL, USA 21-24 July 2004 bfs2004@uic.edu, www.uic.edu/orgs/bachelier/ BS/IMS 2004 6th World Congress of the Bernoulli Society for Mathematical Statistics and Probability, Barcelona, Spain 26-31 July 2004 wc2004@pacifico-meetings.com, +34 93 402 13 85, www.imub.ub.es/events/wc2004 AUGUST 2004 Summer School in Econometrics. The Cointegrated VAR Model: Econometric Methodology and Macroeconomic Applications, Institute of Economics, University of Copenhagen, Denmark 2-22 August 2004 Summerschool@econ.ku.dk, www.econ.ku.dk/summerschool SEPTEMBER 2004 First Bonzenfreies Colloquium on Market Dynamics and Quantitative Economics, Alessandria, Palazzo Borsalino, Italy 9-10 September 2004 colloquium@unipmn.it, www.mfn.unipmn.it/~colloqui/ Risk Analysis 2004. 4th International Conference on Computer Simulation in Risk Analysis and Hazard Mitigation, Aldemar Paradise Royal Mare Hotel, Rhodes, Greece 27-29 September 2004 enquiries@wessex.ac.uk, +44 (0)238 029 3223, www.wessex.ac.uk/conferences/2004/risk04/ OCTOBER 2004 IRC Hedge 2004, InterContinental Hotel, London, UK 10, 11 October 2004 enquiries@irc-conferences.com, www.irc-conferences.com/show_conference.php?id=10 NOVEMBER 2004 IRC DICE 2004, InterContinental Hotel, London, UK 22, 23 November 2004 enquiries@irc-conferences.com, www.irc-conferences.com/show_conference.php?id=13 DECEMBER 2004 Quantitative Methods in Finance 2004, Sydney, Australia 15-18 December 2004 Andrea Schnaufer (qmf@uts.edu.au), +61 2 9514 7737, www.business.uts.edu.au/finance/resources/qmf2004/
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VLBI Digital-Backend Intercomparison Test Report
NASA Technical Reports Server (NTRS)
Whitney, Alan; Beaudoin, Christopher; Cappallo, Roger; Niell, Arthur; Petrachenko, Bill; Ruszczyk, Chester A.; Titus, Mike
2013-01-01
Issues related to digital-backend (DBE) systems can be difficult to evaluate in either local tests or actual VLBI experiments. The 2nd DBE intercomparison workshop at Haystack Observatory on 25-26 October 2012 provided a forum to explicitly address validation and interoperability issues among independent global developers of DBE equipment. This special report discusses the workshop. It identifies DBE systems that were tested at the workshop, describes the test objectives and procedures, and reports and discusses the results of the testing.
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Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar
2017-01-01
Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer-Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that disintegration can be used as performance test of rapidly disintegrating tablets beyond the FDA criteria. The scientific criteria and justification is that dissolution has to be DPP dependent, originated from active pharmaceutical ingredient characteristics and formulations factors have to be negligible.
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Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar
2017-01-01
Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer–Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that disintegration can be used as performance test of rapidly disintegrating tablets beyond the FDA criteria. The scientific criteria and justification is that dissolution has to be DPP dependent, originated from active pharmaceutical ingredient characteristics and formulations factors have to be negligible. PMID:28442890
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Liver enzyme monitoring in patients treated with troglitazone.
Graham, D J; Drinkard, C R; Shatin, D; Tsong, Y; Burgess, M J
2001-08-15
Soon after initial marketing in March 1997, troglitazone, the first thiazolidinedione antidiabetic agent, was found to cause life-threatening acute liver failure. The drug was removed from the market in March 2000. To evaluate the effect of US Food and Drug Administration (FDA) risk management efforts, including repeated labeling changes and "Dear Healthcare Professional" letters, on periodic liver enzyme monitoring of patients taking troglitazone. Claims data from a large, multistate managed care organization were used to establish 4 cohorts of patients (N = 7603) with at least 90 days of health plan enrollment before first troglitazone prescription during 4 consecutive periods spanning April 1997 to September 1999 and representing 4 progressively stringent liver monitoring recommendations. Percentage of eligible troglitazone users in each cohort with baseline, monthly (for up to 6 months of continuous use), and complete (baseline and monthly) enzyme monitoring, based on computerized records of laboratory claims. Baseline testing increased from 15% before any FDA monitoring recommendations (cohort 1) to 44.6% following 4 separate FDA interventions (cohort 4; P<.001). In cohort 4, 33.4% of users had follow-up testing after 1 month of therapy, falling to 13% after 5 months of continuous use. In all cohorts, less than 5% received all recommended liver enzyme tests by the third month of continuous use. The FDA risk management efforts did not achieve meaningful or sustained improvement in liver enzyme testing. Evaluation of the impact of regulatory actions is needed before such actions can be regarded as effective or sufficient.
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Pediatric post-marketing safety systems in North America: assessment of the current status.
McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne
2015-08-01
It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-05
...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.
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Beverages: bottled water. Final rule.
2009-05-29
The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determine whether any of the coliform organisms are E. coli. FDA also is amending the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli will be considered adulterated, and source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from use in the production of bottled water. FDA is also amending its bottled water regulations to require that, before a bottler can use source water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or eliminate the cause of E. coli contamination of that source, and that the bottler must keep records of such actions. Existing regulatory provisions require bottled water manufacturers to keep records of new testing required by this rule. This final rule will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.
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NEUROTOXICITY TESTING IN HUMAN POPULATIONS: WORKSHOP OVERVIEW
A workshop was held in October 1983 at Rougemont, NC to review strategies and methods for neurotoxicity testing in human populations. Behavioral and electrophysiological testing methods were discussed with a major focus on computerized test batteries. Brief reviews of test method...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1990-02-01
This report presents the findings of a research needs workshop on the development of leach tests for contaminated dredged material, held 23-24 June 1988 in Baton Rouge, LA. The workshop was hosted by the Louisiana Water Resources Research Institute and the US Army Engineer Waterways Experiment Station (WES). The workshop participants reviewed results of research on test procedures developed by the WES and provided eight recommendations for directing future research in this area. Workshop panelists were of the opinion that research conducted to date was good and generally validated the basic technical approaches suggested by the 1984 Corps leachate qualitymore » working group. However, the consensus was that much research remains to be done before a leach test (s) will be available for routine use.« less
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Dealing with nuclear-related emotions: an investigation of the despair and empowerment process
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lilly-Weber, J.M.
1986-01-01
The main goal of this study was to determine the short-term and follow-up effectiveness of despair and empowerment workshops. Such workshops are designed to encourage the expression of feelings related to the nuclear threat (as well as other planetary issues), and to generate a greater sense of personal powerfulness. Results were as follows. At pretest, experimental workshop participants reported a significantly lower level of nuclear-related denial, and were found to be significantly more politically active than control participants. When controlling for these pretest differences, no significant differences were found across conditions at post-test or follow-up. In addition, experimental workshop participantsmore » were found to report significantly more powerfulness than nonworkshop control participants at post-test, but no significant post-test differences were found between the two workshop conditions. Open ended evaluation questions, asked only of experimental workshop participants, suggested that most participants responded favorably to the despair and empowerment workshops - particularly in reference to being given the opportunity to express their nuclear-related concerns and to feel supported by others. In summary, this study provides some evidence, despite mixed results, of the effectiveness of despair and empowerment workshops.« less
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The 1977 Goddard Space Flight Center Battery Workshop
NASA Technical Reports Server (NTRS)
1977-01-01
The papers presented were derived from transcripts taken at the Tenth Annual Battery Workshop held at the Goddard Space Flight Center, November 15-17, 1977. The Workshop was attended by manufacturers, users, and government representatives interested in the latest results of testing, analysis, and development of the sealed nickel cadmium cell system. The purpose of the Workshop was to share flight and test experience, stimulate discussion on problem areas, and to review the latest technology improvements.
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Workshops Increase Students' Proficiency at Identifying General and APA-Style Writing Errors
ERIC Educational Resources Information Center
Jorgensen, Terrence D.; Marek, Pam
2013-01-01
To determine the effectiveness of 20- to 30-min workshops on recognition of errors in American Psychological Association-style writing, 58 introductory psychology students attended one of the three workshops (on grammar, mechanics, or references) and completed error recognition tests (pretest, initial posttest, and three follow-up tests). As a…
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Third International Workshop on Grid Simulator Testing of Wind Turbine
Drivetrains | Grid Modernization | NRELA> Third International Workshop on Grid Simulator Testing agenda. For technical questions about the workshop, contact Vahan Gevorgian. A photo of a large group of people standing facing the camera for a group photo Attendees and speakers for the Third International
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Chiowchanwisawakit, Praveena; Ratanarat, Ranistha; Srinonprasert, Varalak
2015-09-01
A knee arthrocentesis (KA) workshop using synthetic knee model was arranged for all sixth-year medical students (MS) in our institute to ensure equity in receiving training. We evaluated confidence level and knowledge of KA and synovial fluid analysis testing pre- and post-workshop for MS. The workshop was divided into two parts. The first part was to provide knowledge in arthrocentesis and synovial fluid interpretation and the second was a practice session on the synthetic model under supervision. This is a report of pre-and post-workshop self-evaluation about the confidence in performing KA (0-10 scales), improvement of knowledge in KA, and synovial fluid analysis earned from attending the workshop. Pearson χ(2) test or Fisher's exact test was used to compare categorical variables, where appropriate. There were 247 MS attended and 228 (92.3%) evaluated the workshops. Ninety-six (42.1%) MS had experience in KA prior to this workshop. The mean (SD) levels of confidence in performing the procedure before and after the workshop were 3.6 (2.5) and 7.5 (1.7), respectively, P < 0.001. Improvement was shown regardless of previous exposure to KA. Knowledge of appropriate testing for synovial fluid was significantly improved in all items explored after the workshop and extended to the better scores earned from a competency examination. A hands-on structured workshop using a synthetic knee model for KA is a successful model for improving medical students' confidence in performing the procedure with evidence of sustaining knowledge in short-term follow-up. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.
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Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.
Sawant, Satin G; Fielden, Mark R; Black, Kurt A
2014-10-01
Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested. Copyright © 2014 Elsevier Inc. All rights reserved.
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NASA Astrophysics Data System (ADS)
Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua
2008-02-01
For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.
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Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo
2018-02-01
This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.
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Achieving Equity in Education Programs for Disabled Women and Girls. A Model Workshop Manual.
ERIC Educational Resources Information Center
Kratovil, Jane; And Others
The model workshop manual is intended for use with state and local special education and sex equity staff. The manual contains a model workshop format, information on problems faced by disabled students, and suggested workshop activities. A sample workshop agenda, accompanying materials and resources developed, compiled, and field-tested at two…
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Variation in tumor response to fluosol-DA (20%)
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sasai, K.; Ono, K.; Nishidai, T.
1989-05-01
The effects of Fluosol-DA 20% (FDA) and carbogen (95% O2/5% CO/sub 2/) on radiosensitivity of the three experimental tumors, SCC VII tumor, RIF-I tumor, and transplanted mammary tumor of C/sub 3/H/He mouse, subcutaneously inoculated in the leg were examined. The effect of FDA plus carbogen, and carbogen alone on radiosensitivity of SCC VII and RIF-I tumors was tested using the in vivo-in vitro assay. The growth curves were obtained for both SCC VII tumor and transplanted mammary tumor. The effect of the combination of FDA and carbogen was only observed in the transplanted mammary tumor. In the other two tumors,more » only the effect of inspiring carbogen was observed. We concluded that the effect of FDA on the radiosensitivity of experimental tumors varies with the kind of tumor systems.« less
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Some Non-FDA Approved Uses for Neuromodulation: A Review of the Evidence.
Lee, Samuel; Abd-Elsayed, Alaa
2016-09-01
Neuromodulation, including spinal cord stimulation and peripheral nerve field stimulation, has been used with success in treating several painful conditions. The FDA approved the use of neuromodulation for a few indications. We review evidence for neuromodulation in treating some important painful conditions that are not currently FDA approved. This review included an online web search for only clinical trials testing the efficacy of neuromodulation in treating coronary artery disease, peripheral vascular disease (PVD), headache, and peripheral field stimulation. Our systematic literature search found 10, 6, and 3 controlled studies relating to coronary artery disease, PVD, and headache, respectively. Our review also included 5 noncontrolled studies relating to peripheral field stimulation, as no controlled studies had been completed. This review article shows compelling evidence based on clinical trials that neuromodulation can be of benefit for patients with serious painful conditions that are not currently approved by the FDA. © 2015 World Institute of Pain.
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DOT National Transportation Integrated Search
2016-10-14
Overview: -Tests executed week of 25 July with 14 GNSS receivers ; -Representative set of equipment from chamber testing from each receiver category (except space) ; -Receivers tested were USG provided ; -Same test instrumentation for wired as with r...
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Coffey, Christopher S; Levin, Bruce; Clark, Christina; Timmerman, Cate; Wittes, Janet; Gilbert, Peter; Harris, Sara
2012-12-01
The clinical trials community has a never-ending search for dependable and reliable ways to improve clinical research. This exploration has led to considerable interest in adaptive clinical trial designs, which provide the flexibility to adjust trial characteristics on the basis of data reviewed at interim stages. Statisticians and clinical investigators have proposed or implemented a wide variety of adaptations in clinical trials, but specific approaches have met with differing levels of support. Within industry, investigators are actively exploring the benefits and pitfalls associated with adaptive designs (ADs). For example, a Drug Information Association (DIA) working group on ADs has engaged regulatory agencies in discussions. Many researchers working on publicly funded clinical trials, however, are not yet fully engaged in this discussion. We organized the Scientific Advances in Adaptive Clinical Trial Designs Workshop to begin a conversation about using ADs in publicly funded research. Held in November of 2009, the 1½-day workshop brought together representatives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the pharmaceutical industry, nonprofit foundations, the patient advocacy community, and academia. The workshop offered a forum for participants to address issues of ADs that arise at the planning, designing, and execution stages of clinical trials, and to hear the perspectives of influential members of the clinical trials community. The participants also set forth recommendations for guiding action to promote the appropriate use of ADs. These recommendations have since been presented, discussed, and vetted in a number of venues including the University of Pennsylvania Conference on Statistical Issues in Clinical Trials and the Society for Clinical Trials annual meeting. To provide a brief overview of ADs, describe the rationale behind conducting the workshop, and summarize the main recommendations that were produced as a result of this workshop. There is a growing interest in the use of adaptive clinical trial designs. However, a number of logistical barriers need to be addressed in order to obtain the potential advantages of an AD. Currently, the pharmaceutical industry is well ahead of academic trialists with respect to addressing these barriers. Academic trialists will need to address important issues such as education, infrastructure, modifications to existing funding models, and the impact on Data and Safety Monitoring Boards (DSMB) in order to achieve the possible benefits of adaptive clinical trial designs.
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USDA FSIS, FDA BAM, and ISO culture methods BD BBL CHROMagar O157 media.
Ritter, Vicki; Kircher, Susan; Dick, Nancy
2009-01-01
BBL CHROMagar O157 media (CO) was evaluated for detection of Escherichia coli O157:H7 in raw ground beef and unpasteurized apple cider. The recovery of E. coli O157:H7 on CO was compared to the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM), U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), and International Organization for Standardization (ISO) reference-plated media using the recommended enrichment broths. Of the 180 food samples tested, 45 were tested using BAM, 45 using the USDA method, and 90 using the ISO method. CO produced comparable results with the reference methods on all matrixes with a sensitivity of 100% and a specificity of 100%. No false negatives were found in testing the food matrixes. There was no statistical difference in recovery based on Chi-square analysis. Method agreement for raw ground beef was 85% for the USDAFSIS method and 95% for the ISO method. Method agreement for unpasteurized apple cider was 100% for the ISO and FDA BAM methods. In all cases where method agreement was <100%, CO detected more positives than the reference method media. Evaluation of known isolates on CO in inclusivity and exclusivity testing had a sensitivity and specificity of 100%. The results of this study demonstrate that CO is an effective medium for the recovery and detection of E. coli O157:H7 in raw ground beef and unpasteurized apple cider using FDA BAM, USDA FSIS, and ISO methods.
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Kinde, Hailu; Goodluck, Helen A; Pitesky, Maurice; Friend, Tom D; Campbell, James A; Hill, Ashley E
2015-12-01
Single swabs (cultured individually) are currently used in the Food and Drug Administration (FDA) official method for sampling the environment of commercial laying hens for the detection of Salmonella enterica ssp. serovar Enteritidis (Salmonella Enteritidis). The FDA has also granted provisional acceptance of the National Poultry Improvement Plan's (NPIP) Salmonella isolation and identification methodology for samples taken from table-egg layer flock environments. The NPIP method, as with the FDA method, requires single-swab culturing for the environmental sampling of laying houses for Salmonella Enteritidis. The FDA culture protocol requires a multistep culture enrichment broth, and it is more labor intensive than the NPIP culture protocol, which requires a single enrichment broth. The main objective of this study was to compare the FDA single-swab culturing protocol with that of the NPIP culturing protocol but using a four-swab pool scheme. Single and multi-laboratory testing of replicate manure drag swab sets (n = 525 and 672, respectively) collected from a Salmonella Enteritidis-free commercial poultry flock was performed by artificially contaminating swabs with either Salmonella Enteritidis phage type 4, 8, or 13a at one of two inoculation levels: low, x¯ = 2.5 CFU (range 2.5-2.7), or medium, x¯ = 10.0 CFU (range 7.5-12). For each replicate, a single swab (inoculated), sets of two swabs (one inoculated and one uninoculated), and sets of four swabs (one inoculated and three uninoculated), testing was conducted using the FDA or NPIP culture method. For swabs inoculated with phage type 8, the NPIP method was more efficient (P < 0.05) for all swab sets at both inoculation levels than the reference method. The single swabs in the NPIP method were significantly (P < 0.05) better than four-pool swabs in detecting Salmonella Enteritidis at the lower inoculation level. In the collaborative study (n = 13 labs) using Salmonella Enteritidis phage type 13a inoculated swabs, there was no significant difference (P > 0.05) between the FDA method (single swabs) and the pooled NPIP method (four-pool swabs). The study concludes that the pooled NPIP method is not significantly different from the FDA method for the detection of Salmonella Enteritidis in drag swabs in commercial poultry laying houses. Consequently based on the FDA's Salmonella Enteritidis rule for equivalency of different methods, the pooled NPIP method should be considered equivalent. Furthermore, the pooled NPIP method was more efficient and cost effective.
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76 FR 1136 - Electroshock Weapons Test and Measurement Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-07
... DEPARTMENT OF COMMERCE National Institute of Standards and Technology Electroshock Weapons Test and Measurement Workshop AGENCY: National Institute of Standards and Technology (NIST), United States..., law enforcement, corrections, academia, military, test instrument manufacturers, etc.) of electroshock...
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Hutt, Charles R.; Nigbor, Robert L.; Evans, John R.
2009-01-01
Testing and specification of seismic and earthquake-engineering sensors and recorders has been marked by significant variations in procedures and selected parameters. These variations cause difficulty in comparing such specifications and test results. In July 1989, and again in May 2005, the U.S. Geological Survey hosted international public/private workshops with the goal of defining widely accepted guidelines for the testing of seismological inertial sensors, seismometers, and accelerometers. This document reports the Proceedings of the 2005 workshop and includes as Appendix 6 the report of the 1989 workshop. In a future document, we will attempt to collate and rationalize a single set of formal guidelines for testing and specifying seismic sensors, supplementing Advanced National Seismic System (ANSS) guidelines on instrumentation likely used by ANSS as its standard for verification, acceptance, and intermittent testing, as well as for responses to ANSS instrument requisitions.
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Lucey, C
2006-11-01
This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.
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NASA Astrophysics Data System (ADS)
Sechler, Phares Lochiel Coleman
State departments of public instruction require that teachers periodically update their licenses throughout their teaching careers. Various professional development events such as in-service workshops, university offerings, and special innovative programs provide opportunities for novice and experienced teachers to grow professionally. The "Team Science" workshop was designed from models supported by research that described guidelines for successful workshop strategies. In evaluating the workshop, the question was asked "Why did not all teachers implement the ideas from the workshop in their science classrooms?" This study investigates the possible relationship between teacher personality characteristics and implementation of technology innovations. Team Science was an extensive workshop program planned to develop science teachers' expertise in using computer and video technology to teach in physical science, chemistry, and physics classrooms in rural school in North Carolina. Upon evaluating the four-year effort, it was found that the 23 participants implemented the technological strategies at various levels. At the higher end of the range of technology use, some teachers exhibited complete integration of the computers and interfacing devices into both the laboratory work and the classroom inquiry. At the lower end of the range, some teachers used the technology very little. The resulting question emerged from the data collected: Do specific teacher personality characteristics (independent variables) correlate with the degree of implementation (dependent variable) of the innovative ideas and tools used in the teacher's science classroom after the in-service workshop? To determine if there were any significant personality traits, each teacher was given five personality tests. The tests were Hunt's Conceptual Development Test, the Paragraph Completion Test; James Rest's Defining Issues Test; Simmons Personal Survey, an emotional tendency test; the Myers-Briggs Type Indicator; and Riggs and Enochs Self-Efficacy Test. The data were analyzed using descriptive statistics, multiple regression, and factor analysis to see what variables were predictors of implementation. The regression analysis revealed that subtests from Myers-Briggs Type Indicator, Simmons Personal Survey, Hunt's Paragraph Completion Test, and Rest's Defining Issues Test could be used to predict implementation. Factor analysis indicated teachers who implemented the technology were "risk takers" and "flexible planners."
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Marketing approval for the lithotripter.
Nightingale, S L; Young, F E
1986-01-01
In December 1984, the Food and Drug Administration (FDA) granted Dornier Systems (FRG) approval to market the external shock wave lithotripter (ESWL) in the USA. The Medical Device Amendments of the Food, Drug, and Cosmetic Act require that the FDA evaluate the safety and effectiveness of medical devices intended for commercial distribution in the U.S. Such evaluation includes basic scientific studies, animal testing, and investigational studies in human subjects, culminating in a judgment concerning acceptable risks in terms of anticipated benefits, and whether the device is effective for its intended use. Prior to human studies in West Germany, Dornier had evaluated the destruction of stones of varying composition, measured the rate and energy of stone destruction, and tested blood samples and lymphocyte cultures exposed to shock waves. In addition, studies in both rats and dogs had demonstrated the feasibility of the technique and evidence of safety. Such data are provided by manufacturers when applying for an investigational device exemption (IDE) from the FDA, which permits clinical studies in humans; such studies also require the approval of an Institutional Review Board. The FDA approved Dornier's IDE, allowing human investigational use of the ESWL in facilities in the U.S., conducted concurrently with similar studies in West Germany. Upon completion of clinical trials, data acquired in vitro, in laboratory animals, and in human investigations are submitted to the FDA for a premarked approval application (PMAA). The Agency was given 6 months to make a decision, taking into consideration the recommendation of an advisory panel of experts from outside the Agency who had reviewed the same data. In its evaluation of the ESWL for safety and effectiveness, the FDA considered the question of alternative practices and procedures to treat nephrolithiasis, including percutaneous nephrolithotomy and open surgical procedures, and the adverse effects of such procedures. Clinical data available at the time of review for approval included reports of treatment of 667 patients in West German centers, and 327 patients treated in three U.S. facilities. Dornier and the FDA initiated discussions concerning the labeling of the device and a postmarketing surveillance plan. These were completed and marketing approval for the ESWL was granted.
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Price analysis of multiple sclerosis disease-modifying therapies marketed in the United States.
Bin Sawad, Aseel; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Turkistani, Fatema
2016-11-01
This study assessed trends in the average wholesale price (AWP) at the market entry of disease-modifying therapies (DMTs) approved by Food and Drug Administration (FDA) in the period 1987-2014. DMT regulatory information was derived from the FDA website. The AWPs per unit at market entry data were derived from the Red Book (Truven Health Analytics Inc.). The AWP history for each DMT was collected from its date of approval to 31 December 2014. The FDA approved label defined daily dose (DDD) for adult patients was obtained from FDA approved labels. The AWP per DDD and the AWP/DDD per year of therapy were computed. Descriptive statistics, Wilcoxon tests, t-test, and multiple linear regression were performed. The statistical significance level was set at 0.05. The FDA approved 12 multiple sclerosis (MS) DMTs, including five new drug applications (NDAs) and seven biologic license applications (BLAs) as of 31 December 2014. The FDA granted orphan designation to five DMTs. There was one DMT approved by the FDA in the 1980s, three in the 1990s, three in 2000s, and five in the period 2010-2014. The market entry inflation-adjusted AWP per DDD was $10.23 for the first DMT (mitoxantrone hydrochloride) that was approved in the 1980s. The median market entry inflation-adjusted AWP per DDD was $12.41 (interquartile range [IQR] = 4.51) for DMTs approved in the 1990s, $71.26 (IQR = 58.35) in the 2000s, and $172.56 (IQR = 84.97) in the period 2010-2014. The median AWP per DDD was statistically significantly different (p = 0.011) for orphan (median = $41.82, IQR = 56.077) compared to non-orphan drugs (median = $171.32, IQR = 199.29). Year of market entry was positively associated with DMT prices at US market entry (p = 0.01). The AWP per DDD for DMTs at market entry increased substantially over time. The increase in DMTs prices exceeded the general consumer price index.
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Advanced Solar Cell Testing and Characterization
NASA Technical Reports Server (NTRS)
Bailey, Sheila; Curtis, Henry; Piszczor, Michael
2005-01-01
The topic for this workshop stems from an ongoing effort by the photovoltaic community and U.S. government to address issues and recent problems associated with solar cells and arrays experienced by a number of different space systems. In April 2003, a workshop session was held at the Aerospace Space Power Workshop to discuss an effort by the Air Force to update and standardize solar cell and array qualification test procedures in an effort to ameliorate some of these problems. The organizers of that workshop session thought it was important to continue these discussions and present this information to the entire photovoltaic community. Thus, it was decided to include this topic as a workshop at the following SPRAT conference.
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Photovoltaic Performance and Reliability Workshop summary
NASA Astrophysics Data System (ADS)
Kroposki, Benjamin
1997-02-01
The objective of the Photovoltaic Performance and Reliability Workshop was to provide a forum where the entire photovoltaic (PV) community (manufacturers, researchers, system designers, and customers) could get together and discuss technical issues relating to PV. The workshop included presentations from twenty-five speakers and had more than one hundred attendees. This workshop also included several open sessions in which the audience and speakers could discuss technical subjects in depth. Several major topics were discussed including: PV characterization and measurements, service lifetimes for PV devices, degradation and failure mechanisms for PV devices, standardization of testing procedures, AC module performance and reliability testing, inverter performance and reliability testing, standardization of utility interconnect requirements, experience from field deployed systems, and system certification.
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The 1988 Goddard Space Flight Center Battery Workshop
NASA Technical Reports Server (NTRS)
Yi, Thomas Y. (Editor)
1993-01-01
This document contains the proceedings of the 21st annual Battery Workshop held at Goddard Space Flight Center, Greenbelt, Maryland on November 1-3, 1988. The Workshop attendees included manufacturers, users, and government representatives interested in the latest developments in battery technology as they relate to high reliability operations and aerospace use. The subjects covered included battery testing methodologies and criteria, life testing of nickel-cadmium cells, testing and operation of nickel-hydrogen batteries in low earth orbit, and nickel-hydrogen technology issues and concerns.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-12
... available space. Abstracts for scientific posters for display at the workshop are also invited (see... submission of poster abstracts is September 16, 2011. ADDRESSES: The workshop will be held at the Center for... scientific posters to be displayed during this workshop. Posters should address current research, development...
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Hamm, Jon; Sullivan, Kristie; Clippinger, Amy J; Strickland, Judy; Bell, Shannon; Bhhatarai, Barun; Blaauboer, Bas; Casey, Warren; Dorman, David; Forsby, Anna; Garcia-Reyero, Natàlia; Gehen, Sean; Graepel, Rabea; Hotchkiss, Jon; Lowit, Anna; Matheson, Joanna; Reaves, Elissa; Scarano, Louis; Sprankle, Catherine; Tunkel, Jay; Wilson, Dan; Xia, Menghang; Zhu, Hao; Allen, David
2017-06-01
Acute systemic toxicity testing provides the basis for hazard labeling and risk management of chemicals. A number of international efforts have been directed at identifying non-animal alternatives for in vivo acute systemic toxicity tests. A September 2015 workshop, Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing, reviewed the state-of-the-science of non-animal alternatives for this testing and explored ways to facilitate implementation of alternatives. Workshop attendees included representatives from international regulatory agencies, academia, nongovernmental organizations, and industry. Resources identified as necessary for meaningful progress in implementing alternatives included compiling and making available high-quality reference data, training on use and interpretation of in vitro and in silico approaches, and global harmonization of testing requirements. Attendees particularly noted the need to characterize variability in reference data to evaluate new approaches. They also noted the importance of understanding the mechanisms of acute toxicity, which could be facilitated by the development of adverse outcome pathways. Workshop breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy to accomplish near-term progress. The workshop steering committee has organized efforts to implement the recommendations of the workshop participants. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Hamm, Jon; Sullivan, Kristie; Clippinger, Amy J.; Strickland, Judy; Bell, Shannon; Bhhatarai, Barun; Blaauboer, Bas; Casey, Warren; Dorman, David; Forsby, Anna; Garcia-Reyero, Natàlia; Gehen, Sean; Graepel, Rabea; Hotchkiss, Jon; Lowit, Anna; Matheson, Joanna; Reaves, Elissa; Scarano, Louis; Sprankle, Catherine; Tunkel, Jay; Wilson, Dan; Xia, Menghang; Zhu, Hao; Allen, David
2017-01-01
Acute systemic toxicity testing provides the basis for hazard labeling and risk management of chemicals. A number of international efforts have been directed at identifying non-animal alternatives for in vivo acute systemic toxicity tests. A September 2015 workshop, Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing, reviewed the state-of-the-science of non-animal alternatives for this testing and explored ways to facilitate implementation of alternatives. Workshop attendees included representatives from international regulatory agencies, academia, nongovernmental organizations, and industry. Resources identified as necessary for meaningful progress in implementing alternatives included compiling and making available high-quality reference data, training on use and interpretation of in vitro and in silico approaches, and global harmonization of testing requirements. Attendees particularly noted the need to characterize variability in reference data to evaluate new approaches. They also noted the importance of understanding the mechanisms of acute toxicity, which could be facilitated by the development of adverse outcome pathways. Workshop breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy to accomplish near-term progress. The workshop steering committee has organized efforts to implement the recommendations of the workshop participants. PMID:28069485
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Ajuwon, Ademola J; Kass, Nancy
2008-01-24
In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants. Three in-depth interviews and one focus group discussion were conducted to assess the training needs of participants. A research ethics training workshop was then conducted with College of Medicine faculty. A 23-item questionnaire that assessed knowledge of research ethics, application of principles of ethics, operations of the Institutional Review Board (IRB) and ethics reasoning was developed to be a pre-post test evaluation of the training workshop. Ninety-seven workshop participants completed the questionnaire before and after the workshop; 59 of them completed a second post-test questionnaire one month after the workshop. The trainees came from a multi-disciplinary background including medicine, nursing, pharmacy, social science and laboratory science. The mean scores for knowledge of the principles of research ethics rose from 0.67 out of 3 points at pre-test to 2.25 at post-test (p < 0.05). Also, 42% correctly mentioned one international guideline or regulation at pretest, with most of those knowing of the Declaration of Helsinki. Trainees' knowledge of the operations of an IRB increased from 6.05 at pre-test to 6.29 at post test out of 7 points. Overall, participants retained much of the knowledge acquired from the workshop one month after its completion. The training improved participants' knowledge of principles of research ethics, international guidelines and regulations and operations of IRBs. It thus provided an opportunity for research ethics capacity development among academic staff in a developing country institution.
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Mars Sample Handling Protocol Workshop Series: Workshop 4
NASA Technical Reports Server (NTRS)
Race Margaret S. (Editor); DeVincenzi, Donald L. (Editor); Rummel, John D. (Editor); Acevedo, Sara E. (Editor)
2001-01-01
In preparation for missions to Mars that will involve the return of samples to Earth, it will be necessary to prepare for the receiving, handling, testing, distributing, and archiving of martian materials here on Earth. Previous groups and committees have studied selected aspects of sample return activities, but specific detailed protocols for the handling and testing of returned samples must still be developed. To further refine the requirements for sample hazard testing and to develop the criteria for subsequent release of sample materials from quarantine, the NASA Planetary Protection Officer convened a series of workshops in 2000-2001. The overall objective of the Workshop Series was to produce a Draft Protocol by which returned martian sample materials can be assessed for biological hazards and examined for evidence of life (extant or extinct) while safeguarding the purity of the samples from possible terrestrial contamination. This report also provides a record of the proceedings of Workshop 4, the final Workshop of the Series, which was held in Arlington, Virginia, June 5-7, 2001. During Workshop 4, the sub-groups were provided with a draft of the protocol compiled in May 2001 from the work done at prior Workshops in the Series. Then eight sub-groups were formed to discuss the following assigned topics: Review and Assess the Draft Protocol for Physical/Chemical Testing Review and Assess the Draft Protocol for Life Detection Testing Review and Assess the Draft Protocol for Biohazard Testing Environmental and Health/Monitoring and Safety Issues Requirements of the Draft Protocol for Facilities and Equipment Contingency Planning for Different Outcomes of the Draft Protocol Personnel Management Considerations in Implementation of the Draft Protocol Draft Protocol Implementation Process and Update Concepts This report provides the first complete presentation of the Draft Protocol for Mars Sample Handling to meet planetary protection needs. This Draft Protocol, which was compiled from deliberations and recommendations from earlier Workshops in the Series, represents a consensus that emerged from the discussions of all the sub-groups assembled over the course of the five Workshops of the Series. These discussions converged on a conceptual approach to sample handling, as well as on specific analytical requirements. Discussions also identified important issues requiring attention, as well as research and development needed for protocol implementation.
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Nasr, Justine A; Falatko, John; Halalau, Alexandra
2018-01-01
To assess the impact of four evidence based medicine (EBM) critical appraisal education workshops in improving residents' EBM knowledge and skills. The eligible participants in the workshops were 88 residents-in-training, postgraduate years one through four, rotating through the outpatient internal medicine clinic. Four EBM workshops, consisting of 3 days each (30 minutes daily), were taught by our faculty. Topics covered included critical appraisal of randomized controlled trials, case-control and cohort studies, diagnosis studies, and systematic reviews. As a program evaluation, anonymous pre-workshop and post-workshop tests were administered. Each of the four sets of tests showed improvement in scores: therapy from 58% to 77% (42% response rate), harm from 65% to 73% (38% response rate), diagnosis from 49% to 68% (49% response rate), and systematic review from 57% to 72% (30% response rate). We found that teaching EBM in four short workshops improved EBM knowledge and critical appraisal skills related to the four topics.
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Laboratory investigation of a fluid-dynamic actuator designed for CubeSats
NASA Astrophysics Data System (ADS)
Noack, Daniel; Brieß, Klaus
2014-03-01
In general, the attitude control systems (ACS) for precise spacecraft operations rely on reaction wheel technology for angular momentum exchange. In this paper, an alternative ACS concept using fluid rings for this task is presented. This novel actuator—based on Lorentz body force—uses a direct-current conduction pump to accelerate liquid metal within a circular channel structure. As working fluid for the fluid-dynamic actuator (FDA) serves the eutectic alloy Galinstan. Along with a microcontroller that runs the FDA, a MEMS gyroscope is implemented on the device for closed loop operation. Several models of FDAs for small satellites were tested successfully for various attitude control maneuvers on an air bearing platform. Thus advantageous performance has been achieved in terms of torque and power consumption in comparison to similarly dimensioned reaction wheels. Further considerable advantages are wear-free operations and higher reliability as well as expected passive damping properties. A next generation FDA prototype for nano-satellites is currently in development for in-orbit testing.
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Özenci, Volkan; Patel, Robin; Ullberg, Måns; Strålin, Kristoffer
2018-01-18
Although there are several US Food and Drug Administration (FDA)-approved/cleared molecular microbiology diagnostics for direct analysis of patient samples, all are single target or panel-based tests. There is no FDA-approved/cleared diagnostic for broad microbial detection. Polymerase chain reaction (PCR)/electrospray ionization-mass spectrometry (PCR/ESI-MS), commercialized as the IRIDICA system (Abbott) and formerly PLEX-ID, had been under development for over a decade and had become CE-marked and commercially available in Europe in 2014. Capable of detecting a large number of microorganisms, it was under review at the FDA when, in April 2017, Abbott discontinued it. This turn of events represents not only the loss of a potential diagnostic tool for infectious diseases but may be a harbinger of similar situations with other emerging and expensive microbial diagnostics, especially genomic tests. © The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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... the drugs usually used to treat them. Some examples include staphylococci ("staph") and Pseudomonas aeruginosa . Sometimes there ... susceptibility testing techniques is an active area of research. As the FDA approves more of these rapid ...
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Hill, Jessica A; Lee, Su Yeon; Njambi, Lucy; Corson, Timothy W; Dimaras, Helen
2015-01-01
Clinical genetic testing is becoming an integral part of medical care for inherited disorders. While genetic testing and counseling are readily available in high-income countries, in low- and middle-income countries like Kenya genetic testing is limited and genetic counseling is virtually non-existent. Genetic testing is likely to become widespread in Kenya within the next decade, yet there has not been a concomitant increase in genetic counseling resources. To address this gap, we designed an interactive workshop for clinicians in Kenya focused on the genetics of the childhood eye cancer retinoblastoma. The objectives were to increase retinoblastoma genetics knowledge, build genetic counseling skills and increase confidence in those skills. The workshop was conducted at the 2013 Kenyan National Retinoblastoma Strategy meeting. It included a retinoblastoma genetics presentation, small group discussion of case studies and genetic counseling role-play. Knowledge was assessed by standardized test, and genetic counseling skills and confidence by questionnaire. Knowledge increased significantly post-workshop, driven by increased knowledge of retinoblastoma causative genetics. One-year post-workshop, participant knowledge had returned to baseline, indicating that knowledge retention requires more frequent reinforcement. Participants reported feeling more confident discussing genetics with patients, and had integrated more genetic counseling into patient interactions. A comprehensive retinoblastoma genetics workshop can increase the knowledge and skills necessary for effective retinoblastoma genetic counseling.
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An Overview of the Annual NASA Tire/Runway Friction Workshop and Lessons Learned
NASA Technical Reports Server (NTRS)
Yager, Thomas J.
2005-01-01
This paper summarizes the organization efforts, objectives, scope, agenda, test procedures and results from eleven years of conducting the NASA Tire/Runway Friction Workshop. The paper will also summarize the lessons learned between 1994 and 2004. A description of the various friction, texture and roughness equipment used during these workshops at NASA Wallops Flight Facility on the eastern shore of Virginia will be provided together with the range of test surfaces available for evaluation. The need for friction measuring equipment calibration centers is discussed and plans for future workshops are identified.
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Animal models for acute radiation syndrome drug discovery.
Singh, Vijay K; Newman, Victoria L; Berg, Allison N; MacVittie, Thomas J
2015-05-01
Although significant scientific advances have been made over the past six decades in developing safe, nontoxic and effective radiation/medical countermeasures (MCMs) for acute radiation syndrome (ARS), no drug has been approved by the US FDA. The availability of adequate animal models is a prime requisite under the criteria established by the FDA 'animal rule' for the development of novel MCMs for ARS and the discovery of biomarkers for radiation exposure. This article reviews the developments of MCMs to combat ARS, with particular reference to the various animal models (rodents: mouse and rat; canine: beagle; minipigs and nonhuman primates [NHPs]) utilized for the in-depth evaluation. The objective, pathways and challenges of the FDA Animal Efficacy Rule are also discussed. There are a number of well-defined animal models, the mouse, canine and NHP, that are being used for the development of MCMs. Additional animal models, such as the minipig, are under development to further assist in the identification, efficacy testing and approval of MCMs under the FDA Animal Efficacy Rule.
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Data gaps in toxicity testing of chemicals allowed in food in the United States.
Neltner, Thomas G; Alger, Heather M; Leonard, Jack E; Maffini, Maricel V
2013-12-01
In the United States, chemical additives cannot be used in food without an affirmative determination that their use is safe by FDA or additive manufacturer. Feeding toxicology studies designed to estimate the amount of a chemical additive that can be eaten safely provide the most relevant information. We analyze how many chemical additives allowed in human food have feeding toxicology studies in three toxicological information sources including the U.S. Food and Drug Administration's (FDA) database. Less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food, 21.6% have feeding studies necessary to estimate a safe level of exposure and 6.7% have reproductive or developmental toxicity data in FDA's database. A program is needed to fill these significant knowledge gaps by using in vitro and in silico methods complemented with targeted in vivo studies to ensure public health is protected. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.
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Ourso, André
2012-01-01
Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.
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... serology is performed for their patients . 11 Several ELISA-based serologic tests are FDA approved and available ... The most commonly used test, HerpeSelect HSV-2 Elisa might be falsely positive at low index values ( ...
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The Oncogenic Palmitoyi-Protein Network in Prostate Cancer
2015-06-01
obesity drug, Ortistat, which inhibits the enzyme fatty acid synthase (FASN), has been shown to slow the growth of human prostate tumors in mice...Orlistat, an FDA-approved anti- obesity drug, suppresses the growth of human prostate tumors in nude mice.5 Despite these advances, the role of lipid...We also tested in vivo whether this network is vulnerable to an intervention that employs a dietary strategy in combination with an FDA-approved
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Competitiveness Improvement Project Informational Workshop
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sinclair, Karin C; Preus, Robert W; Dana, Scott
This presentation was given at the Competitiveness Improvement Project (CIP) Informational Workshop on December 6, 2017. Topics covered during the workshop include an overview of the CIP, past projects, scoring criteria, technical support opportunities, certification body requirements, standards applicable to distributed wind generators, information on the National Electric Code, certification testing requirements, test site requirements, National Environmental Policy Act, design review, levelized cost of energy, procurement/contracting, project management/deliverables, and outreach materials.
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Regulating biopharmaceuticals under CDER versus CBER: an insider's perspective.
Schwieterman, William D
2006-10-01
The FDA has recently transferred jurisdiction for the regulation of certain biopharmaceuticals from the Center for Biologics, Evaluation and Research to the Center for Drugs, Evaluation and Research, where they will be reviewed in the same FDA divisions as are traditional pharmaceutical agents. With this transfer, sponsors of investigational biopharmaceuticals should expect changes in the regulatory requirements the FDA imposes on the clinical development plans, including an increase in the size and number of pivotal studies; more consistent requirements for conducting preclinical tests in two animal species; increased emphasis on organ structure and function as components of primary endpoints; more emphasis on characterizing dose-ranging and pharmacology; more intense scrutinizing of product advertising; and decreased direct communication with the review team.
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Development and approval of vaccines in the United States.
Botstein, P
1986-01-01
In the United States, vaccines and the establishments in which they are manufactured are required to be licensed by the Food and Drug Administration (FDA) before the vaccine can be marketed. This licensing process, as well as the development and investigation of vaccines, is regulated by the FDA's Office of Biologics Research and Review. An application for licensing must contain information supporting the safety, effectiveness, purity and potency of the product. These are data obtained during the investigational phase and then submitted by a commercial sponsor for review and approval. Inspections, surveillance and laboratory testing are performed by the FDA before and after issuance of a license for marketing. The procedures and policies in the investigational and licensing phases of vaccine development are described.
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Blood Glucose Monitoring Devices
... of interferences ability to transmit data to a computer cost of the meter cost of the test ... Performance FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment ...
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Rapid toxicity assessment using an in vivo enzyme test for Brachionus plicatilis (Rotifera).
Moffat, B D; Snell, T W
1995-02-01
A 1-hr in vivo enzyme inhibition assay based on esterase activity has good potential for marine toxicity assessment. A test was developed for the rotifer Brachionus plicatilis based on the nonfluorescent substrate fluorescein diacetate (FDA), which is metabolized by esterases to a fluorescent product. Enzyme inhibition, as determined by reduced fluorescence, can be scored visually or quantified using a fluorometer. Quantification of fluorescence permits the calculation of NOEC, LOEC, chronic value, and IC20. The 1-hr esterase inhibition test has sensitivity comparable to that of 24-hr rotifer acute tests for several compounds. The toxicity of six compounds was examined using the quantified assay. The resulting IC20s were within a factor of 3 of the 24-hour LC50s. IC20 values ranged from 0.017 mg/l for tributyltin to 3.1 mg/l for zinc, with an average coefficient of variation of 17.8%. Electrophoretic analysis of rotifer homogenates suggested that a single C esterase (acetylesterase) was responsible for FDA metabolism in B. plicatilis. Several other aquatic species are capable of metabolizing FDA, including Brachionus calyciflorus, Mysidopsis bahia, Menidia beryllina, Pimephales promelas, Ceriodaphnia dubia, Daphnia pulex, Artemia salina, and Ophryotrocha sp. The esterase inhibition test is an attractive tool for assessing aquatic toxicity because of its speed, simplicity, sensitivity, and applicability to a broad range of aquatic species.
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FDA advisory committees meet January 26 on Salk HIV-1 immunogen.
1995-01-06
Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment.
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Statistical innovations in the medical device world sparked by the FDA.
Campbell, Gregory; Yue, Lilly Q
2016-01-01
The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies.
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Guidelines for Standardized Testing of Broadband Seismometers and Accelerometers
Hutt, Charles R.; Evans, John R.; Followill, Fred; Nigbor, Robert L.; Wielandt, Erhard
2010-01-01
Testing and specification of seismic and earthquake-engineering sensors and recorders has been marked by significant variations in procedures and selected parameters. These variations cause difficulty in comparing such specifications and test results. In July 1989, and again in May 2005, the U.S. Geological Survey hosted international pub-lic/private workshops with the goal of defining widely accepted guidelines for the testing of seismological inertial sensors, seismometers, and accelerometers. The Proceedings of the 2005 workshop have been published and include as appendix 6 the report of the 1989 workshop. This document represents a collation and rationalization of a single set of formal guidelines for testing and specifying broadband seismometers and accelerometers.
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DOT National Transportation Integrated Search
2017-03-30
This presentation, which was given during the GPS-ABC Workshop VI in Washington, DC on March 30, 2017 details the authors' radiated testing protocols and results. GPS receiver testing was carried out April 25-29, 2016 at the Army : Research Laborator...
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ERIC Educational Resources Information Center
Hudesman, John; Wiesner, Ezra
1978-01-01
Examines whether the degree of facilitating and debilitating test anxiety is different for students who volunteer for test anxiety desensitization workshops than it is for the general college population, whether test anxiety in urban community college students is correlated, and whether either or both of the AAT scales are predictive of student…
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Yuan, Qingjun; Gao, Junning; Wu, Dongliang; Zhang, Shihua; Mamitsuka, Hiroshi; Zhu, Shanfeng
2016-01-01
Motivation: Identifying drug–target interactions is an important task in drug discovery. To reduce heavy time and financial cost in experimental way, many computational approaches have been proposed. Although these approaches have used many different principles, their performance is far from satisfactory, especially in predicting drug–target interactions of new candidate drugs or targets. Methods: Approaches based on machine learning for this problem can be divided into two types: feature-based and similarity-based methods. Learning to rank is the most powerful technique in the feature-based methods. Similarity-based methods are well accepted, due to their idea of connecting the chemical and genomic spaces, represented by drug and target similarities, respectively. We propose a new method, DrugE-Rank, to improve the prediction performance by nicely combining the advantages of the two different types of methods. That is, DrugE-Rank uses LTR, for which multiple well-known similarity-based methods can be used as components of ensemble learning. Results: The performance of DrugE-Rank is thoroughly examined by three main experiments using data from DrugBank: (i) cross-validation on FDA (US Food and Drug Administration) approved drugs before March 2014; (ii) independent test on FDA approved drugs after March 2014; and (iii) independent test on FDA experimental drugs. Experimental results show that DrugE-Rank outperforms competing methods significantly, especially achieving more than 30% improvement in Area under Prediction Recall curve for FDA approved new drugs and FDA experimental drugs. Availability: http://datamining-iip.fudan.edu.cn/service/DrugE-Rank Contact: zhusf@fudan.edu.cn Supplementary information: Supplementary data are available at Bioinformatics online. PMID:27307615
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Yuan, Qingjun; Gao, Junning; Wu, Dongliang; Zhang, Shihua; Mamitsuka, Hiroshi; Zhu, Shanfeng
2016-06-15
Identifying drug-target interactions is an important task in drug discovery. To reduce heavy time and financial cost in experimental way, many computational approaches have been proposed. Although these approaches have used many different principles, their performance is far from satisfactory, especially in predicting drug-target interactions of new candidate drugs or targets. Approaches based on machine learning for this problem can be divided into two types: feature-based and similarity-based methods. Learning to rank is the most powerful technique in the feature-based methods. Similarity-based methods are well accepted, due to their idea of connecting the chemical and genomic spaces, represented by drug and target similarities, respectively. We propose a new method, DrugE-Rank, to improve the prediction performance by nicely combining the advantages of the two different types of methods. That is, DrugE-Rank uses LTR, for which multiple well-known similarity-based methods can be used as components of ensemble learning. The performance of DrugE-Rank is thoroughly examined by three main experiments using data from DrugBank: (i) cross-validation on FDA (US Food and Drug Administration) approved drugs before March 2014; (ii) independent test on FDA approved drugs after March 2014; and (iii) independent test on FDA experimental drugs. Experimental results show that DrugE-Rank outperforms competing methods significantly, especially achieving more than 30% improvement in Area under Prediction Recall curve for FDA approved new drugs and FDA experimental drugs. http://datamining-iip.fudan.edu.cn/service/DrugE-Rank zhusf@fudan.edu.cn Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press.
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[Interactive workshops as a dissemination strategy in psychology].
Martínez-Martínez, Kalina Isela; Carrascosa-Venegas, César; Ayala-Velázquez, Héctor
2003-01-01
To assess whether interactive workshops are an effective strategy for promoting a psychological intervention model among healthcare providers, to treat problem drinkers. The study was conducted between the years 1999 and 2000, among 206 healthcare providers at seven Instituto Mexicano del Seguro Social (Mexican Institute of Social Security, IMSS) clinics. Study subjects were selected by hospital executive officers. The study design is a quasi-experimental pre-test/post-test study. Data on providers' attitudes, interests, and knowledge were collected using a questionnaire. After that, interactive workshops were conducted, and the same questionnaire was applied again at the end of the workshops. Statistical analysis was carried out using Student's t test for matched samples. Statistically significant differences were found in participants' knowledge on alcoholism t (206, 205) = -9.234, p = 0.001, as well as in their interest t (206, 205) = -2.318, p = 0.021. Interactive workshops are an effective tool to disseminate the Guided Self-Help Program conducted in IMSS clinics. Healthcare providers can become change-inducing/promoting agents of psychological innovations.
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Austin, J; Alvero, A M; Fuchs, M M; Patterson, L; Anger, W K
2009-07-01
Employees with limited education may be excluded from advanced training due to assumptions that they might not learn rapidly. However, preparatory training may be able to overcome missing experience in education. The purpose of this study was to test the hypothesis that computer-based training (CBT) in supervisor skills of Latino agricultural workers would improve subsequent performance in a workshop designed to teach supervisor skills. Ten men born and educated in Mexico participated in the study; all spoke Spanish, the language of the training. Five participants (mean 6.4 years of education) completed supervisor skills CBT, and five participants (mean 8.2 years of education) completed hazard communication (HazCom) CBT as a control condition. Following the CBT, all participants completed a two-day face-to-face workshop on supervisory skills conducted by an experienced behavior management consultant. Although the groups did not differ in their knowledge scores on a multiple-choice test before the face-to-face workshop, after the workshop the HazCom group had a mean test score of 51.2% (SD = 8.7) while the supervisor group had a higher mean test score of 65.2% (SD = 14.3). The difference was marginally significant by a t-test (p = 0.052), and the effect size was large (d = 1.16). The results suggest that computer-based training in supervisor skills can be effective in preparing participants with limited education to learn supervisor skills from a face-to-face workshop. This result suggests that limited educational attainment is not a barrier to learning the complex knowledge required to supervise employees, that pre-training may improve learning in a workshop format, and that training may be presented effectively in a computer-based format to employees with limited education.
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Entrepreneurship Education: Workshops and Entrepreneurial Intentions
ERIC Educational Resources Information Center
Pruett, Mark
2012-01-01
Using data collected from participants in an entrepreneurship education workshop series, the author examined the series' impact and tested a model of entrepreneurial intentions incorporating social and psychological factors. He found that entrepreneurial disposition and workshop participation significantly influenced intentions, exposure to role…
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Workshop Results: Teaching Geoscience to K-12 Teachers
NASA Astrophysics Data System (ADS)
Nahm, A.; Villalobos, J. I.; White, J.; Smith-Konter, B. R.
2012-12-01
A workshop for high school and middle school Earth and Space Science (ESS) teachers was held this summer (2012) as part of an ongoing collaboration between the University of Texas at El Paso (UTEP) and El Paso Community College (EPCC) Departments of Geological Sciences. This collaborative effort aims to build local Earth science literacy and educational support for the geosciences. Sixteen teachers from three school districts from El Paso and southern New Mexico area participated in the workshop, consisting of middle school, high school, early college high school, and dual credit faculty. The majority of the teachers had little to no experience teaching geoscience, thus this workshop provided an introduction to basic geologic concepts to teachers with broad backgrounds, which will result in the introduction of geoscience to many new students each year. The workshop's goal was to provide hands-on activities illustrating basic geologic and scientific concepts currently used in introductory geology labs/lectures at both EPCC and UTEP to help engage pre-college students. Activities chosen for the workshop were an introduction to Google Earth for use in the classroom, relative age dating and stratigraphy using volcanoes, plate tectonics utilizing the jigsaw pedagogy, and the scientific method as a think-pair-share activity. All activities where designed to be low cost and materials were provided for instructors to take back to their institutions. A list of online resources for teaching materials was also distributed. Before each activity, a short pre-test was given to the participants to gauge their level of knowledge on the subjects. At the end of the workshop, participants were given a post-test, which tested the knowledge gain made by participating in the workshop. In all cases, more correct answers were chosen in the post-test than the individual activity pre-tests, indicating that knowledge of the subjects was gained. The participants enjoyed participating in these activities and intend to use them in their classes in the future. Copies of the materials used in this workshop are available upon request.
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FDA Benchmark Medical Device Flow Models for CFD Validation.
Malinauskas, Richard A; Hariharan, Prasanna; Day, Steven W; Herbertson, Luke H; Buesen, Martin; Steinseifer, Ulrich; Aycock, Kenneth I; Good, Bryan C; Deutsch, Steven; Manning, Keefe B; Craven, Brent A
Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent groups to assess current CFD techniques. The primary goal of this article is to summarize the FDA initiative and to report recent findings from the benchmark blood pump model study. Discrepancies between CFD predicted velocities and those measured using particle image velocimetry most often occurred in regions of flow separation (e.g., downstream of the nozzle throat, and in the pump exit diffuser). For the six pump test conditions, 57% of the CFD predictions of pressure head were within one standard deviation of the mean measured values. Notably, only 37% of all CFD submissions contained hemolysis predictions. This project aided in the development of an FDA Guidance Document on factors to consider when reporting computational studies in medical device regulatory submissions. There is an accompanying podcast available for this article. Please visit the journal's Web site (www.asaiojournal.com) to listen.
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Summary of Technical Meeting To Compare US/French Approaches for Physical Protection Test Beds
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mack, Thomas Kimball; Martinez, Ruben; Thomas, Gerald
In September 2015, representatives of the US Department of Energy/National Nuclear Security Administration, including test bed professionals from Sandia National Laboratories, and representatives of the French Alternative Energies and Atomic Energy Commission participated in a one-week workshop to share best practices in design, organization, operations, utilization, improvement, and performance testing of physical protection test beds. The intended workshop outcomes were to (1) share methods of improving respective test bed methodologies and programs and (2) prepare recommendations for standards regarding creating and operating testing facilities for nations new to nuclear operations. At the workshop, the French and American subject matter expertsmore » compared best practices as developed at their respective test bed sites; discussed access delay test bed considerations; and presented the limitations/ constraints of physical protection test beds.« less
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ERIC Educational Resources Information Center
Asian Cultural Centre for UNESCO, Tokyo (Japan).
The proceedings of the sixth regional workshop consist of a description of the project and the workshop; a description of the field survey, preparation, and field testing of materials by the group; five papers presented at the workshop; and notes on planned follow-up activities in the participating countries. The workshop culminated a project on…
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77 FR 43827 - International Workshop on Alternative Methods for Leptospira
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES International Workshop on Alternative Methods for... NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ``International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and...
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Applied Anthropology and the Grade Schools
ERIC Educational Resources Information Center
Gonzalez, Nancie L.
1973-01-01
Three kinds of training experience for teaching Man: A Course of Study'' were tested: (1) a 3-week intensive anthropology workshop; (2) a 1-week intensive workshop in prepared materials use; and (3) a workshop in both anthropology and the use of prepared materials. (NQ)
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Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo, Richard A
2004-01-01
Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
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Lee, Samuel; Abd-Elsayed, Alaa
2016-12-01
Neuromodulation, including cavernous nerve stimulation, gastric electrical stimulation, deep brain stimulation, and vagus nerve stimulation, has been used with success in treating several functional disease conditions. The FDA has approved the use of neuromodulation for a few indications. We discuss in our review article the evidence of using neuromodulation for treating some important disorders involving the autonomic nervous system that are not currently FDA approved. This was a review article that included a systematic online web search for human clinical studies testing the efficacy of neuromodulation in treating erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure. Our review includes all feasibility studies, nonrandomized clinical trials, and randomized controlled trials. Our systematic literature search found 3, 4, 5, 4, 1, and 4 clinical studies relating to erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure, respectively. This review article shows preliminary support based on clinical studies that neuromodulation can be of benefit for patients with important autonomic nervous system disease conditions that are not currently approved by the FDA. All of these investigational uses are encouraging; further studies are necessary and warranted for all indications discussed in this review before achieving FDA approval. © 2016 International Neuromodulation Society.
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Perovskite Solar Cell Stability Workshop: Quick Look Report
2016-08-12
Commercialization of Perovskite PV – Markets, Concerns, Opportunities” by Dirk Weiss, First Solar , USA j. “Expectations for PV Product Testing Today” by Sarah...Perovskite Solar Cell Stability Workshop Quick-Look Report Held by the Office of Naval Research at University...Workshop Summary, 11-12 Aug 2016 4. TITLE AND SUBTITLE Perovskite Solar Cell Stability Workshop: Quick-Look Report 5. FUNDING NUMBERS 6. AUTHOR(S
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33 CFR 157.12f - Workshop functional test requirements.
Code of Federal Regulations, 2013 CFR
2013-07-01
... CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12f Workshop functional test requirements. (a) Each oil content meter and each control section of a monitoring system must be subjected to a... protocol must be received with each unit delivered. (b) A functional test conducted on an oil content meter...
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33 CFR 157.12f - Workshop functional test requirements.
Code of Federal Regulations, 2014 CFR
2014-07-01
... CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12f Workshop functional test requirements. (a) Each oil content meter and each control section of a monitoring system must be subjected to a... protocol must be received with each unit delivered. (b) A functional test conducted on an oil content meter...
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33 CFR 157.12f - Workshop functional test requirements.
Code of Federal Regulations, 2012 CFR
2012-07-01
... CARRYING OIL IN BULK Design, Equipment, and Installation § 157.12f Workshop functional test requirements. (a) Each oil content meter and each control section of a monitoring system must be subjected to a... protocol must be received with each unit delivered. (b) A functional test conducted on an oil content meter...
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Synthetic risks, risk potency, and carcinogen regulation.
Viscusi, W K; Hakes, J K
1998-01-01
This article analyzes a comprehensive sample of over 350 chemicals tested for carcinogenicity to assess the determinants of the probability of regulation. Controlling for differences in the risk potency and noncancer risks, synthetic chemicals have a significantly higher probability of regulation overall: this is due to the greater likelihood of U.S. Food and Drug Administration (FDA) regulation. Measures of risk potency increase the probability of regulation by the U.S. Environmental Protection Agency (EPA), have a somewhat weaker positive effect on regulation by the U.S. Occupational Safety and Health Administration (OSHA), and decrease the likelihood of regulation by the FDA. The overall regulatory pattern is one in which the FDA targets synthetic chemicals and chemicals that pose relatively minor cancer risk. The EPA particularly performed more sensibly than many critics have suggested.
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Kremzner, Mary
2016-01-01
Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ). This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight. With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems. Published by Elsevier Inc.
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A stress management workshop improves residents' coping skills.
McCue, J D; Sachs, C L
1991-11-01
We describe the effectiveness of a stress management workshop designed for physicians. Of the 64 medicine, pediatrics, and medicine-pediatrics residents who agreed to participate in the workshop, the 43 who could be freed from clinical responsibilities constituted the intervention group; the 21 residents who could not be freed from clinical responsibilities were asked to be the nonintervention group. The ESSI Stress Systems Instrument and Maslach Burnout Inventory were administered to control subjects and workshop participants 2 weeks before and 6 weeks after the workshop. The half-day workshops taught management of the stresses of medical practice through: (1) learning and practicing interpersonal skills that increase the availability of social support; (2) prioritization of personal, work, and educational demands; (3) techniques to increase stamina and attend to self-care needs; (4) recognition and avoidance of maladaptive responses; and (5) positive outlook skills. Overall, the ESSI Stress Systems Instrument test scores for the workshop participants improved (+1.27), while the nonintervention group's mean scores declined (-0.65). All 21 individual ESSI Stress Systems Instrument scale items improved for the workshop, compared with eight of 21 items for the nonintervention group. The workshop group improved in the Maslach Burnout Inventory emotional exhaustion scale and deteriorated less than the nonintervention group in the depersonalization scale. We conclude that a modest, inexpensive stress management workshop was received positively, and can lead to significant short-term improvement in stress and burnout test scores for medicine and pediatrics residents.
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Lai, Hui-Ling
2011-11-01
The purpose of this study was to assess the effects of an educational workshop on knowledge of and attitude toward therapeutic use of music and aesthetic experiences with music among first-line nurses. A one-group pre-test/post-test design was used. Forty-six first-line nurses, aged 21-56 years, were recruited from seven different hospitals. Questionnaires were used to assess the nurses' knowledge of and attitude toward therapeutic use of music and aesthetic experience with music before and after the workshop, and 3 months after the workshop. The workshop comprised three sessions; the nurses participated in 8h of instruction the first week and 4h, the second week covering analytical music appreciation, music staves comprehension, theory and practice of music therapy, and evidence-based music intervention. Educational workshop significantly improved knowledge of and attitudes toward therapeutic use of music and music aesthetic experiences (p<0.001). A sustained effect of the workshop was found at follow up 3-month after workshop. The mean change in scores for music aesthetic experiences between nurse with and without music backgrounds differed significantly (p=0.01). The workshop enhanced the knowledge of and attitude toward therapeutic use of music and aesthetic experiences with music among first-line nurses. Copyright © 2010 Elsevier Ltd. All rights reserved.
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Baral, N; Nepal, A K; Paudel, B H; Lamsal, M
2015-01-01
Faculty development by conducting regular training, workshops and research related to medical education has been a key feature to upgrade quality of medical education. The aim of this study was to explore responses of the health science teachers, students and peers after the workshop after providing training on student assessment tools and teaching-learning methods. Two teacher-training workshops were conducted to the faculty members of B.P. Koirala Institute of Health Sciences from the departments of basic, clinical and allied sciences in Oct. 2010 and Jan. 2011. Qualitative questionnaire based study was conducted, and the questions were validated before the study by expert peer review process. The effect of the training workshop in real classroom outcomes was assessed incorporating student's feedback, evaluation by peers and the self-evaluation by the teacher trainees. Pre-test and post-test scores of the participating teachers, before and after the workshop were 62.53 and 71.17 respectively. Among the participants 90.3% teachers expressed enhanced in their role as a teacher for medical undergraduates after the workshop. In present study, the faculty members showed accrued interest to participate in teacher's training workshops. The peer evaluation of teacher's performance in their real classroom situations were rated higher than evaluation by the students. Therefore, such training workshops will have a greater impact on the ability of teachers in effective teaching in real classroom situations.
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Neish, Emma M.; Miller, Nancy S.; Dhere, Tanvi; Burd, Eileen M.; Carpentieri, Cynthia; Sitchenko, Kaitlin L.
2017-01-01
ABSTRACT Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent Clostridium difficile infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic donors present many challenges to clinical laboratories. This minireview summarizes FDA regulatory changes, principles of donor selection, and recommended laboratory screening practices for fecal microbiota transplantation. PMID:28077694
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76 FR 27355 - 2011 National Institute of Justice Body Armor Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-11
... Institute of Justice Body Armor Workshop AGENCY: National Institute of Justice, DOJ. ACTION: Notice of Meeting of the 2011 NIJ Body Armor Workshop. SUMMARY: The National Institute of Justice invites manufacturers of ballistic-resistant body armor, ballistic laboratory testing facilities and other interested...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-07
...; Comment Request: Cognitive Testing of Instrumentation and Materials for the Population Assessment of..., unless it displays a currently valid OMB control number. Proposed Collection: Title: Cognitive Testing of... Administration (FDA). NIDA is requesting generic approval from OMB for cognitive testing of the PATH study's...
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Rengasamy, Samy; Sbarra, Deborah; Nwoko, Julian; Shaffer, Ronald
2015-01-01
Background Surgical N95 filtering facepiece respirators (FFRs), certified by the National Institute for Occupational Safety and Health (NIOSH) as a respirator and cleared by the Food and Drug Administration (FDA) as a surgical mask, are often used to protect from the inhalation of infectious aerosols and from splashes/sprays of body fluids in health care facilities. A shortage of respirators can be expected during a pandemic. The availability of surgical N95 FFRs can potentially be increased by incorporating FDA clearance requirements in the NIOSH respirator approval process. Methods Fluid resistance of NIOSH-approved N95 FFRs, and FDA-cleared surgical N95 FFRs and surgical masks was tested using the ASTM F1862 method at 450 and 635 cm/sec velocities and compared with the results from a third-party independent laboratory. Blood penetration through different layers of filter media of masks were also analyzed visually. Results Four N95 FFR models showed no test failures at both velocities. The penetration results obtained in the NIOSH laboratory were comparable to those from the third-party independent laboratory. The number of respirator samples failing the test increased with increasing test velocity. Conclusions The results indicate that several NIOSH-approved N95 FFR models would likely pass FD clearance requirements for resistance to synthetic blood penetration. PMID:26231551
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Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong
2017-10-01
Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.
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Myers, R I; Larsen, D W; Tsao, M; Castellano, C; Becherer, L D; Fontana, F; Ghormley, N R; Meier, G
1991-10-01
The purposes of this study were to determine if the quantity of protein deposited (QPD) upon hydrogel lenses was affected by enzymatic cleaning and to test the potential relation between QPD and visible protein deposition (VPD) and change. Seventy-four contact lens patients classified as "heavy depositors" wore new lenses for an average of 80 (SD = 32) days. Cleaning and disinfection solutions varied. One lens was cleaned weekly by a papain enzymatic treatment. The distribution of QPD measurements was bimodal and was related to the FDA material for nonionic, low water content lenses (FDA Materials Group no. 1). The mean deposition was 45 micrograms/cm2 (N = 112) compared with that of ionic, high water content lenses (FDA Materials Group no. 4), which was 1010 micrograms/cm2 (N = 30). VPD distributions were the same for the FDA Group no. 1 and no. 4 lenses. Enzymatic treatment did not significantly reduce QPD; however, enzymatic treatment did reduce VPD. Thus QPD and VPD are independent phenomena and possible reasons for this are given.
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Opportunities to integrate new approaches in genetic toxicology: an ILSI-HESI workshop report.
Zeiger, Errol; Gollapudi, Bhaskar; Aardema, Marilyn J; Auerbach, Scott; Boverhof, Darrell; Custer, Laura; Dedon, Peter; Honma, Masamitsu; Ishida, Seiichi; Kasinski, Andrea L; Kim, James H; Manjanatha, Mugimane G; Marlowe, Jennifer; Pfuhler, Stefan; Pogribny, Igor; Slikker, William; Stankowski, Leon F; Tanir, Jennifer Y; Tice, Raymond; van Benthem, Jan; White, Paul; Witt, Kristine L; Thybaud, Véronique
2015-04-01
Genetic toxicity tests currently used to identify and characterize potential human mutagens and carcinogens rely on measurements of primary DNA damage, gene mutation, and chromosome damage in vitro and in rodents. The International Life Sciences Institute Health and Environmental Sciences Institute (ILSI-HESI) Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity Testing held an April 2012 Workshop in Washington, DC, to consider the impact of new understanding of biology and new technologies on the identification and characterization of genotoxic substances, and to identify new approaches to inform more accurate human risk assessment for genetic and carcinogenic effects. Workshop organizers and speakers were from industry, academe, and government. The Workshop focused on biological effects and technologies that would potentially yield the most useful information for evaluating human risk of genetic damage. Also addressed was the impact that improved understanding of biology and availability of new techniques might have on genetic toxicology practices. Workshop topics included (1) alternative experimental models to improve genetic toxicity testing, (2) Biomarkers of epigenetic changes and their applicability to genetic toxicology, and (3) new technologies and approaches. The ability of these new tests and technologies to be developed into tests to identify and characterize genotoxic agents; to serve as a bridge between in vitro and in vivo rodent, or preferably human, data; or to be used to provide dose response information for quantitative risk assessment was also addressed. A summary of the workshop and links to the scientific presentations are provided. © 2014 Wiley Periodicals, Inc.
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Write on Target: Preparing Young Writers To Succeed on State Writing Achievement Tests.
ERIC Educational Resources Information Center
Thomason, Tommy; York, Carol
This handbook guides teachers through nine workshops designed to share strategies for success on writing tests. The workshops in the handbook give practical ideas that can be implemented in the elementary classroom to set the stage for test success without compromising children's growth as writers. Following a foreword by Michael R. Sampson and…
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Proceedings of the Fifth NASA/NSF/DOD Workshop on Aerospace Computational Control
NASA Technical Reports Server (NTRS)
Wette, M. (Editor); Man, G. K. (Editor)
1993-01-01
The Fifth Annual Workshop on Aerospace Computational Control was one in a series of workshops sponsored by NASA, NSF, and the DOD. The purpose of these workshops is to address computational issues in the analysis, design, and testing of flexible multibody control systems for aerospace applications. The intention in holding these workshops is to bring together users, researchers, and developers of computational tools in aerospace systems (spacecraft, space robotics, aerospace transportation vehicles, etc.) for the purpose of exchanging ideas on the state of the art in computational tools and techniques.
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Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D
2017-01-01
Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.
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Hypnotic medications and suicide: risk, mechanisms, mitigation, and the FDA
McCall, W. Vaughn; Benca, Ruth M.; Rosenquist, Peter B.; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C.; Case, Doug; Rumble, Meredith; Krystal, Andrew D.
2016-01-01
Objective Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has warnings regarding suicide in the prescribing information of hypnotics. We conducted a review of the evidence for and against hypnotics increasing the risk of suicide. Method This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms ‘suicide’ and ‘suicidal’ with each of the modern FDA-approved hypnotics. The FDA website was searched for post-marketing safety reviews, and the FDA was contacted to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Report system. Results The epidemiological studies show that hypnotics are associated with increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be previously suicidal. On the other hand, ongoing research is testing whether treatment of insomnia might reduce suicidality in depressed adults. Conclusions This review indicates hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess both types of possible effects: 1) an increase in suicidality due to central nervous system impairments from a given hypnotic medication; and 2) a decrease in suicidality due to improving insomnia. PMID:27609243
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Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A
2018-05-09
Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.
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Statistical Analysis of CFD Solutions From the Fifth AIAA Drag Prediction Workshop
NASA Technical Reports Server (NTRS)
Morrison, Joseph H.
2013-01-01
A graphical framework is used for statistical analysis of the results from an extensive N-version test of a collection of Reynolds-averaged Navier-Stokes computational fluid dynamics codes. The solutions were obtained by code developers and users from North America, Europe, Asia, and South America using a common grid sequence and multiple turbulence models for the June 2012 fifth Drag Prediction Workshop sponsored by the AIAA Applied Aerodynamics Technical Committee. The aerodynamic configuration for this workshop was the Common Research Model subsonic transport wing-body previously used for the 4th Drag Prediction Workshop. This work continues the statistical analysis begun in the earlier workshops and compares the results from the grid convergence study of the most recent workshop with previous workshops.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Lu, Z.
The involvement of medical physicists in diagnostic ultrasound imaging service is increasing due to QC and accreditation requirements. The goal of this ultrasound hands-on workshop is to demonstrate quality control (QC) testing in diagnostic ultrasound and to provide updates in ACR ultrasound accreditation requirements. The first half of this workshop will include two presentations reviewing diagnostic ultrasound QA/QC and ACR ultrasound accreditation requirements. The second half of the workshop will include live demonstrations of basic QC tests. An array of ultrasound testing phantoms and ultrasound scanners will be available for attendees to learn diagnostic ultrasound QC in a hands-on environmentmore » with live demonstrations and on-site instructors. The targeted attendees are medical physicists in diagnostic imaging. Learning Objectives: Gain familiarity with common elements of a QA/QC program for diagnostic ultrasound imaging dentify QC tools available for testing diagnostic ultrasound systems and learn how to use these tools Learn ACR ultrasound accreditation requirements Jennifer Walter is an employee of American College of Radiology on Ultrasound Accreditation.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
.... FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities... comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA... controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is...
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Humphries, R M; Hindler, J A
2016-07-01
Accurate and timely performance of antimicrobial susceptibility testing (AST) by the clinical laboratory is paramount to combating antimicrobial resistance. The ability of laboratories in the United States to effectively perform ASTs is challenged by several factors. Some, such as new resistance mechanisms and the associated evolution of testing recommendations and breakpoints, are inevitable. Others are entirely man-made. These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how commercial AST systems can be used for diagnostic testing, the absence of up-to-date performance data on these systems, and the lack of commercially available FDA-cleared tests for newer antimicrobial agents or for older agents with updated breakpoints. This viewpoint will highlight contemporary AST challenges faced by the clinical laboratory, and propose some solutions. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.
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Nelson, Christina; Hojvat, Sally; Johnson, Barbara; Petersen, Jeannine; Schriefer, Marty; Beard, C Ben; Petersen, Lyle; Mead, Paul
2014-04-18
In 2005, CDC and the Food and Drug Administration (FDA) issued a warning regarding the use of Lyme disease tests whose accuracy and clinical usefulness have not been adequately established. Often these are laboratory-developed tests (also known as "home brew" tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. Recently, CDC has received inquiries regarding a laboratory-developed test that uses a novel culture method to identify Borrelia burgdorferi, the spirochete that causes Lyme disease. Patient specimens reportedly are incubated using a two-step pre-enrichment process, followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Specimens that test positive by immunostaining or PCR are deemed "culture positive". Published methods and results for this laboratory-developed test have been reviewed by CDC. The review raised serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis.
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Ramirez, Tzutzuy; Beken, Sonja; Chlebus, Magda; Ellis, Graham; Griesinger, Claudius; De Jonghe, Sandra; Manou, Irene; Mehling, Annette; Reisinger, Kerstin; Rossi, Laura H; van Benthem, Jan; van der Laan, Jan Willem; Weissenhorn, Renate; Sauer, Ursula G
2015-10-01
The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them. Copyright © 2015 Elsevier Inc. All rights reserved.
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The Cultural Elements of Academic Honesty
ERIC Educational Resources Information Center
Thompson, LaNette W.; Bagby, Janet H.; Sulak, Tracey N.; Sheets, Janet; Trepinski, Tonya M.
2017-01-01
We examined the impact of a workshop on Asian international graduate students' understanding of a U.S. American university's concept of academic honesty. The workshop, taught from a cultural perspective, explained the U.S. American university's expectations to 19 participants. Data was obtained from a workshop post-test and from subsequent…
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Motivational Procedures Workshop: Planning, Conduct, Evaluation and Follow-up.
ERIC Educational Resources Information Center
Mohan, Madan; Hull, Ronald E.
This description of the Motivational Procedures workshop deals with the problem of low motivational levels of students at all grade levels. The objectives of the workshop included creating awareness of the problem, testing motivation principles, determining through feedback the effectiveness of materials, and developing assessment instruments. The…
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Introduction to Deaf-Blindness Workshop.
ERIC Educational Resources Information Center
Rhodes, Larry
This document presents the agenda and materials distributed at a 1-day introductory workshop on deaf-blindness. Introductory material explains the workshop's purpose and rules. A short test contrasts facts and myths about deaf-blindness. A handout presents information on the dynamics of deaf-blindness, etiologies in the adult deaf-blind…
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[Development and assessment of a workshop on repair of third and fourth degree obstetric tears].
Emmanuelli, V; Lucot, J-P; Closset, E; Cosson, M; Deruelle, P
2013-04-01
To evaluate the educational interest of a workshop on diagnosis and repair of obstetric anal sphincter injuries (OASIS). To evaluate the theoretical and anatomical knowledge of OASIS repair by French residents in obstetrics and gynecology. The workshop was composed of slides, video of repair and training using cadaveric sow's anal sphincters. All subjects were tested with a questionnaire before and after the course. Thirty residents participated. Classification of OASIS was known by 13.3% of the residents before the training versus 93.3% after the workshop (P<0.001). Initially, only 6.7% correctly classified operative procedures of OASIS versus 86.7% after the workshop (P<0.001). Per pre-test, 90% of residents did not know how to identify the internal anal sphincter (IAS) versus 3% at post-test (P<0.001). Seventy percent of trainees correctly identified the external anal sphincter (EAS) at the beginning of training. Before the course, no resident knew the repair of the IAS and only one third knew the technical repair of the EAS. After the workshop, the theoretical knowledge of EAS and IAS repair were acquired by all (P<0.001). Structured hands-on training improves significantly the knowledge of OASIS diagnosis and repair. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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NASA Technical Reports Server (NTRS)
Rumsey, Christopher L. (Compiler)
2007-01-01
The papers presented here are from the Langley Research Center Workshop on Computational Fluid Dynamics (CFD) Validation of Synthetic Jets and Turbulent Separation Control (nicknamed "CFDVAL2004"), held March 2004 in Williamsburg, Virginia. The goal of the workshop was to bring together an international group of CFD practitioners to assess the current capabilities of different classes of turbulent flow solution methodologies to predict flow fields induced by synthetic jets and separation control geometries. The workshop consisted of three flow-control test cases of varying complexity, and participants could contribute to any number of the cases. Along with their workshop submissions, each participant included a short write-up describing their method for computing the particular case(s). These write-ups are presented as received from the authors with no editing. Descriptions of each of the test cases and experiments are also included.
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Consortium on Methods Evaluating Tobacco: Research Tools to Inform FDA Regulation of Snus.
Berman, Micah L; Bickel, Warren K; Harris, Andrew C; LeSage, Mark G; O'Connor, Richard J; Stepanov, Irina; Shields, Peter G; Hatsukami, Dorothy K
2017-10-04
The U.S. Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this paper is to describe these assessment methods using a U.S. manufactured "snus" as the test product. In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This paper integrates COMET's findings over the last 4 years. Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, and consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Palmer, Jessica Elizabeth
2012-01-01
Should consumers be able to obtain information about their own bodies, even if it has no proven medical value? Direct-to-consumer ("DTC") genomic companies offer consumers two services: generation of the consumer's personal genetic sequence, and interpretation of that sequence in light of current research. Concerned that consumers will misunderstand genomic information and make ill-advised health decisions, regulators, legislators and scholars have advocated restricted access to DTC genomic services. The Food and Drug Administration, which has historically refrained from regulating most genetic tests, has announced its intent to treat DTC genomic services as medical devices because they make "medical claims." This Article argues that FDA regulation of genomic services as medical devices would be counterproductive. Clinical laboratories conducting genetic tests are already overseen by a federal regime administered by the Centers for Medicare and Medicaid Services. While consumers and clinicians would benefit from clearer communication of test results and their health implications, FDA's gatekeeping framework is ill-suited to weigh the safety and efficacy of genomic information that is not medically actionable in traditional ways. Playing gatekeeper would burden FDA's resources, conflict with the patient-empowering policies promoted by personalized medicine initiatives, impair individuals' access to information in which they have powerful autonomy interests, weaken novel participatory research infrastructures, and set a poor precedent for the future regulation of medical information. Rather than applying its risk-based regulatory framework to genetic information, FDA should ameliorate regulatory uncertainty by working with the Federal Trade Commission and Centers for Medicare and Medicaid Services to ensure that DTC genomic services deliver analytically valid data, market and implement their services in a truthful manner, and fully disclose the limitations of their services. Federal agencies with relevant expertise should collaborate on standards and best practices for interpreting genetic information in light of scientific uncertainty, and an adverse event reporting system should be established to collect empirical data verifying or disproving the speculative harms resulting from individual access to genetic information. Most of all, FDA should take advantage of this opportunity to adapt its regulatory process to an increasingly informational health ecosystem.
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NASA Astrophysics Data System (ADS)
Deustua, Susana; Ros, Rosa
2015-08-01
Since 2009, the Network for Astronomy School Education (NASE) has held 55+ workshops in countries in Asia, Africa, Europe and Latin America, training more than 1200 teachers and potentially reaching one million or more students. Like modern professional development programs, NASE’s emphasis is on interactive, hands-on learning. However, our emphasis is on “low-tech” tools that are readily available, and, inexpensive. Teachers are led through a series of activities that cover a wide range of topics in astronomy, more or less equivalent to that covered in the typical 1st year astronomy course in US colleges.In 2014 we adopted the Astronomy Diagnostic Test as pre- and post- workshop tests to guage the change in teachers’ knowledge as a result of participation in this intervention. In this paper we discuss the first results using the Astronomy Diagnostic Test in astronomy workshops in Peru during March 2014 and February 2015. NASE workskhops were held at the facilities of the Observatorio de Radio de Sicaya of the Instituto Geofisico del Peru, in Chupaca, a farming community approximately 20 km from the Andean city, Huancayo. Sponsors of the Chupaca workshop were the IGP, NASE and the UGEL (regional school district). The second workshop was held at the University of Ica, in the coastal city of Ica, 250 km south of Lima, sponsored by the Instituto Geofisico del Peru and the University, and the 3rd workshop in Lima.We will discuss our results, which for the most part do indeed show a positive change in knowledge, but in a couple of areas the change is either null or negative.
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Research-oriented medical education for graduate medical students.
Deo, Madhav G
2013-01-01
In most parts of the world, medical education is predominantly geared to create service personnel for medical and health services. Training in research is ignored, which is a major handicap for students who are motivated to do research. The main objective of this study was to develop, for such students, a cost-effective 'in-study' research training module that could be adopted even by medical colleges, which have a modest research infrastructure, in different regions of India. Short-duration workshops on the clinical and laboratory medicine research methods including clinical protocol development were held in different parts of India to facilitate participation of students from various regions. Nine workshops covering the entire country were conducted between July 2010 and December 2011. Participation was voluntary and by invitation only to the recipients of the Indian Council of Medical Research-Short-term Studentship programme (ICMR- STS), which was taken as an index of students' research motivation. Faculty was drawn from the medical institutions in the region. All expenses on students, including their travel, and that of the faculty were borne by the academy. Impact of the workshop was judged by the performance of the participants in pre- and post-workshop tests with multiple-choice questions (MCQs) containing the same set of questions. There was no negative marking. Anonymous student feedback was obtained using a questionnaire. Forty-one per cent of the 1009 invited students attended the workshops. These workshops had a positive impact on the participants. Only 20% students could pass and just 2.3% scored >80% marks in the pre-workshop test. There was a three-fold increase in the pass percentage and over 20% of the participants scored >80% marks (A grade) in the post-workshop test. The difference between the pre- and post- workshop performance was statistically significant at all the centres. In the feedback from participants, the workshop received an average rating of 8.1 on a scale of 1 to 10. This cost-effective, 'in-study' module of short-duration 'mobile' workshops can be used to educate graduate medical students in basic research procedures employed in clinical and laboratory medicine research. The module is suitable for resource-strapped developing nations. Copyright 2013, NMJI.
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Hospital preparedness for Ebola virus disease: a training course in the Philippines
Carlos, Celia; Capistrano, Rowena; Tobora, Charissa Fay; delos Reyes, Mari Rose; Lupisan, Socorro; Corpuz, Aura; Aumentado, Charito; Suy, Lyndon Lee; Hall, Julie; Donald, Julian; Counahan, Megan; Curless, Melanie S; Rhymer, Wendy; Gavin, Melanie; Lynch, Chelsea; Black, Meredith A; Anduyon, Albert D; Buttner, Petra
2015-01-01
Objective To develop, teach and evaluate a training workshop that could rapidly prepare large numbers of health professionals working in hospitals in the Philippines to detect and safely manage Ebola virus disease (EVD). The strategy was to train teams (each usually with five members) of key health professionals from public, private and local government hospitals across the Philippines who could then guide Ebola preparedness in their hospitals. Methods The workshop was developed collaboratively by the Philippine Department of Health and the country office of the World Health Organization. It was evaluated using a pre- and post-workshop test and two evaluation forms. χ2 tests and linear regression analyses were conducted comparing pre- and post-workshop test results. Results A three-day workshop was developed and used to train 364 doctors, nurses and medical technologists from 78 hospitals across the Philippines in three initial batches. Knowledge about EVD increased significantly (P < 0.009) although knowledge on transmission remained suboptimal. Confidence in managing EVD increased significantly (P = 0.018) with 96% of participants feeling more prepared to safely manage EVD cases. Discussion: The three-day workshop to prepare hospital staff for EVD was effective at increasing the level of knowledge about EVD and the level of confidence in managing EVD safely. This workshop could be adapted for use as baseline training in EVD in other developing countries to prepare large numbers of hospital staff to rapidly detect, isolate and safely manage EVD cases. PMID:25960920
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Yisau, J I; Adagbada, A O; Bamidele, T; Fowora, M; Brai, B I C; Adebesin, O; Bamidele, M; Fesobi, T; Nwaokorie, F O; Ajayi, A; Smith, S I
2017-07-08
The deployment of molecular biology techniques for diagnosis and research in Nigeria is faced with a number of challenges, including the cost of equipment and reagents coupled with the dearth of personnel skilled in the procedures and handling of equipment. Short molecular biology training workshops were conducted at the Nigerian Institute of Medical Research (NIMR), to improve the knowledge and skills of laboratory personnel and academics in health, research, and educational facilities. Five-day molecular biology workshops were conducted annually between 2011 and 2014, with participants drawn from health, research facilities, and the academia. The courses consisted of theoretical and practical sessions. The impact of the workshops on knowledge and skill acquisition was evaluated by pre- and post-tests which consisted of 25 multiple choice and other questions. Sixty-five participants took part in the workshops. The mean knowledge of molecular biology as evaluated by the pre- and post-test assessments were 8.4 (95% CI 7.6-9.1) and 13.0 (95 CI 11.9-14.1), respectively. The mean post-test score was significantly greater than the mean pre-test score (p < 0.0001). The five-day molecular biology workshop significantly increased the knowledge and skills of participants in molecular biology techniques. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(4):313-317, 2017. © 2017 The International Union of Biochemistry and Molecular Biology.
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Experimental evaluation of the Skylab orbital workshop ventilation system concept
NASA Technical Reports Server (NTRS)
Allums, S. L.; Hastings, L. J.; Ralston, J. T.
1972-01-01
Extensive testing was conducted to evaluate the Orbital Workshop ventilation concept. Component tests were utilized to determine the relationship between operating characteristics at 1 and 0.34 atm. System tests were conducted at 1 atm within the Orbital Workshop full-scale mockup to assess delivered volumetric flow rate and compartment air velocities. Component tests with the Anemostat circular diffusers (plenum- and duct-mounted) demonstrated that the diffuser produced essentially equivalent airflow patterns and velocities in 1- and 0.34-atm environments. The tests also showed that the pressure drop across the diffuser could be scaled from 1 to 0.34 atm using the atmosphere pressure ratio. Fan tests indicated that the performance of a multiple, parallel-mounted fan cluster could be predicted by summing the single-fan flow rates at a given delta P.
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PE Workshop II. Proceedings of the Second Parabolic Equation Workshop
1993-01-01
13) The values for the Padd coefficients tabulated in [8] were generated using the same accuracy and stability constraints used to generate the Pad6...singly to that subject. With the expectation that such a workshop would soon occur, the general topic of underwater acoustic scattering was minimized...were not generated for all of the test cases. The available reference solutions were forwarded to the participants on 23 April 1991. Since the workshop
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NASA Astrophysics Data System (ADS)
DeSilva, L. Ajith; Pullen, Adam; Hasbun, J. E.
2018-05-01
This article examines the effect of voluntary workshops on students’ performance in a university for algebra-based introductory physics on the topics of electricity, magnetism and related areas. A workshop is an optional one-hour-per-week session that promotes a small group’s peer instruction and co-operative learning, in order to enhance the conceptual understanding of physical principles and to improve problem-solving skills. During the workshops, a small group of students were encouraged to exchange ideas in a co-operative learning environment. Most students enrolled were poorly motivated, underprepared, and did not possess the prerequisite mathematics needed. For those who attended workshops, the result of scores on a standardized conceptual survey in electricity and magnetism showed a pre-test-post-test gain of 21% in the number of correct responses. This is to be contrasted with a 5% increase for those students who did not attend workshops. Further, we present a breakdown of the final letter grades obtained by students who attended workshops versus those who did not. Since the introduction of the workshops (out of 374 students), 95% of those who attended made a ‘C’ or better in the course. This compares to only 50% of the students who did not attend workshops and making a ‘C’ or better. The workshops have been offered since the Fall of 2010, but analyzed data includes fourteen years of student letter grades from 2001 to 2014 in order to study the effects on the workshops of the D, F, or W grades (DFW rate). We report a 7% reduction of the DFW rates, which we attribute to the incorporation of the workshops. The workshops are easy to implement and relatively inexpensive, yet appear to be an effective instructional method that enhances the success of underprepared students.
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.
Ekins, Sean; Freundlich, Joel S; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus
Ekins, Sean; Freundlich, Joel S.; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested. PMID:25653841
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Presentation for new binder tests and specification change workshop.
DOT National Transportation Integrated Search
2014-06-18
The research team of the Texas A&M Transportation Institute (TTI) developed and taught a new asphalt binder test workshop, which was held at the Cedar Park branch of the Texas Department of Transportation (TxDOT) on June 18, 2014. The focus of the wo...
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Test Report, BioLite HomeStove with Wood Fuel, Air Pollutant Emissions and Fuel Efficiency
Test results were obtained in accordance with ISO (International Organization for Standardization) IWA (International Workshop Agreement) 11:2012 that was unanimously affirmed by more than 90 stakeholders at the ISO International Workshop on Cookstoves on February 28-29, 2012 in ...
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Test Report, BioLite Home Stove with Wood Fuel, Air Pollutant Emissions and Fuel Efficiency
Test results were obtained in accordance with ISO (International Organization for Standardization) IWA (International Workshop Agreement) 11:2012 that was unanimously affirmed by more than 90 stakeholders at the ISO International Workshop on Cookstoves on February 28-29, 2012 in ...
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Goldberg, Roger A; Flynn, Harry W; Miller, Darlene; Gonzalez, Serafin; Isom, Ryan F
2013-07-01
To report the 1-year clinical outcomes of an outbreak of Streptococcus endophthalmitis after intravitreal injection of bevacizumab, including visual acuity outcomes, microbiological testing, and compound pharmacy investigations by the Food and Drug Administration (FDA). Retrospective consecutive case series. Twelve eyes of 12 patients who developed endophthalmitis after receiving intravitreal bevacizumab prepared by a single compounding pharmacy. Medical records of patients were reviewed; phenotypic and DNA analyses were performed on microbes cultured from patients and from unused syringes. An inspection report by the FDA based on site visits to the pharmacy that prepared the bevacizumab syringes was summarized. Visual acuity, interventions received, time to intervention, microbiological consistency, and FDA inspection findings. Between July 5 and 8, 2011, 12 patients developed endophthalmitis after intravitreal bevacizumab from syringes prepared by a single compounding pharmacy. All patients received initial vitreous tap and injection, and 8 patients (67%) subsequently underwent pars plana vitrectomy (PPV). After 12 months follow-up, outcomes have been poor. Seven patients (58%) required evisceration or enucleation, and only 1 patient regained pre-injection visual acuity. Molecular testing using real-time polymerase chain reaction, partial sequencing of the groEL gene, and multilocus sequencing of 7 housekeeping genes confirmed the presence of a common strain of Streptococcus mitis/oralis in vitreous specimens and 7 unused syringes prepared by the compounding pharmacy at the same time. An FDA investigation of the compounding pharmacy noted deviations from standard sterile technique, inconsistent documentation, and inadequate testing of equipment required for safe preparation of medications. In this outbreak of endophthalmitis, outcomes have been generally poor, and PPV did not improve visual results at 1-year follow-up. Molecular testing confirmed a common strain of S. mitis/oralis. Contamination seems to have occurred at the compounding pharmacy, where numerous problems in sterile technique were noted by public health investigators. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Goldberg, Roger A.; Flynn, Harry W.; Miller, Darlene; Gonzalez, Serafin; Isom, Ryan F.
2013-01-01
Purpose To report the one-year clinical outcomes of an outbreak of Streptococcus endophthalmitis after intravitreal injection of bevacizumab, including visual acuity outcomes, microbiological testing and compound pharmacy investigations by the Food and Drug Administration (FDA). Design Retrospective consecutive case series. Participants 12 eyes of 12 patients who developed endophthalmitis after receiving intravitreal bevacizumab prepared by a single compounding pharmacy. Methods Medical records of patients were reviewed; phenotypic and DNA analyses were performed on microbes cultured from patients and from unused syringes. An inspection report by the FDA based on site-visits to the pharmacy that prepared the bevacizumab syringes was summarized. Main Outcome Measures Visual acuity, interventions received, time-to-intervention; microbiological consistency; FDA inspection findings. Results Between July 5 and July 8, 2011, 12 patients developed endophthalmitis after intravitreal bevacizumab from syringes prepared by a single compounding pharmacy. All patients received initial vitreous tap and injection, and eight (67%) subsequently underwent pars plana vitrectomy (PPV). After twelve months follow-up, outcomes have been poor: 7 patients (58%) required evisceration or enucleation, and only one patient regained pre-injection visual acuity. Molecular testing using real time polymerase chain reaction, partial sequencing of the groEL gene, and multilocus sequencing of 7 housekeeping genes confirmed the presence of a common strain of Streptococcus mitis/oralis in vitreous specimens and seven unused syringes prepared by the compounding pharmacy at the same time. An FDA investigation of the compounding pharmacy noted deviations from standard sterile technique, inconsistent documentation, and inadequate testing of equipment required for safe preparation of medications. Conclusions In this outbreak of endophthalmitis, outcomes have been generally poor and PPV did not improve visual results at one year follow-up. Molecular testing confirmed a common strain of Streptococcus mitis/oralis. Contamination appears to have occurred at the compounding pharmacy, where numerous problems in sterile technique were noted by public health investigators. PMID:23453511
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Skates, Steven J.; Gillette, Michael A.; LaBaer, Joshua; Carr, Steven A.; Anderson, N. Leigh; Liebler, Daniel C.; Ransohoff, David; Rifai, Nader; Kondratovich, Marina; Težak, Živana; Mansfield, Elizabeth; Oberg, Ann L.; Wright, Ian; Barnes, Grady; Gail, Mitchell; Mesri, Mehdi; Kinsinger, Christopher R.; Rodriguez, Henry; Boja, Emily S.
2014-01-01
Protein biomarkers are needed to deepen our understanding of cancer biology and to improve our ability to diagnose, monitor and treat cancers. Important analytical and clinical hurdles must be overcome to allow the most promising protein biomarker candidates to advance into clinical validation studies. Although contemporary proteomics technologies support the measurement of large numbers of proteins in individual clinical specimens, sample throughput remains comparatively low. This problem is amplified in typical clinical proteomics research studies, which routinely suffer from a lack of proper experimental design, resulting in analysis of too few biospecimens to achieve adequate statistical power at each stage of a biomarker pipeline. To address this critical shortcoming, a joint workshop was held by the National Cancer Institute (NCI), National Heart, Lung and Blood Institute (NHLBI), and American Association for Clinical Chemistry (AACC), with participation from the U.S. Food and Drug Administration (FDA). An important output from the workshop was a statistical framework for the design of biomarker discovery and verification studies. Herein, we describe the use of quantitative clinical judgments to set statistical criteria for clinical relevance, and the development of an approach to calculate biospecimen sample size for proteomic studies in discovery and verification stages prior to clinical validation stage. This represents a first step towards building a consensus on quantitative criteria for statistical design of proteomics biomarker discovery and verification research. PMID:24063748
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Skates, Steven J; Gillette, Michael A; LaBaer, Joshua; Carr, Steven A; Anderson, Leigh; Liebler, Daniel C; Ransohoff, David; Rifai, Nader; Kondratovich, Marina; Težak, Živana; Mansfield, Elizabeth; Oberg, Ann L; Wright, Ian; Barnes, Grady; Gail, Mitchell; Mesri, Mehdi; Kinsinger, Christopher R; Rodriguez, Henry; Boja, Emily S
2013-12-06
Protein biomarkers are needed to deepen our understanding of cancer biology and to improve our ability to diagnose, monitor, and treat cancers. Important analytical and clinical hurdles must be overcome to allow the most promising protein biomarker candidates to advance into clinical validation studies. Although contemporary proteomics technologies support the measurement of large numbers of proteins in individual clinical specimens, sample throughput remains comparatively low. This problem is amplified in typical clinical proteomics research studies, which routinely suffer from a lack of proper experimental design, resulting in analysis of too few biospecimens to achieve adequate statistical power at each stage of a biomarker pipeline. To address this critical shortcoming, a joint workshop was held by the National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), and American Association for Clinical Chemistry (AACC) with participation from the U.S. Food and Drug Administration (FDA). An important output from the workshop was a statistical framework for the design of biomarker discovery and verification studies. Herein, we describe the use of quantitative clinical judgments to set statistical criteria for clinical relevance and the development of an approach to calculate biospecimen sample size for proteomic studies in discovery and verification stages prior to clinical validation stage. This represents a first step toward building a consensus on quantitative criteria for statistical design of proteomics biomarker discovery and verification research.
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NASA Astrophysics Data System (ADS)
Jusoh, Norwahyu; Fong Yeong, Yin; Keong Lau, Kok; Shariff, Azmi Mohd
2017-08-01
In the present work, zeolite T and aminosilane grafted zeolite T are embedded into 6FDA-durene polyimide phase for the fabrication of mixed matrix membranes (MMMs). FESEM images demonstrated that the improvement of interfacial adhesion between zeolite and polymer phases in MMM loaded with aminosilane grafted zeolite T was not significant as compared to zeolite T/6FDA-durene MMM. From the gas permeation test, CO2/CH4 selectivity up to 26.4 was achieved using MMM containing aminosilane grafted zeolite T, while MMM loaded with ungrafted zeolite T showed CO2/CH4 selectivity of 19.1. In addition, MMM incorporated with aminosilane grafted zeolite T particles successfully lies on Robeson upper bound 2008, which makes it an attractive candidate for CO2/CH4 separation.
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Arciniegas Calle, Maria C; Lobelo, Felipe; Jiménez, Mario A; Páez, Diana C; Cortés, Sebastian; de Lima, Andrés; Duperly, John
2016-12-05
The physical inactivity pandemic and related non-communicable diseases have made it imperative for medical doctors (MDs) to effectively provide lifestyle counseling as part of prevention and treatment plans for patients. A one-day certification workshop was designed to improve MDs PA prescription knowledge, as part of the Exercise is Medicine® (EIM®) global health initiative. The objective was to determine knowledge gain of MDs participating in a standardized, one-day PA prescription workshop performed throughout Latin America (LA). A 20-question multiple-choice test on PA topics, based on international guidelines, was completed before and after the workshop. Pre and post-test analyses, without a control group, were performed on 1044 MDs after the 8-h workshop that was delivered 41 times across 12 LA countries, from January 2014 to January 2015. Knowledge improvement was determined using the class-average normalized gain and individual relative gain. T-tests with 95% confidence interval levels were conducted to analyze differences between MD specialties. Test scores improved on average from 67 to 82% after the workshop (p <0.001). The average total individual relative gain was 29% [CI: 26 to 32%]. Relative gain by country ranged from 9.3% [CI: 2 to 16%; Nicaragua] to 73% [CI: 47 to 98%; Dominican Republic]. The mean of the 41 workshops' class-average normalized gain was 46% [CI: 42 to 51%]. The largest groups of participants were general practitioners (GPs) (33%; n = 348), internal medicine (19%; n = 194), and family medicine (9%n = 92) specialists. Relative gain for GPs was not different than for all grouped primary care specialties (30% vs. 27%, p =0.48). The knowledge gain was higher for the workshop modules on screening/risk stratification and prescription (43% [CI: 39-48%] and 38% [CI: 34-42%], than for the module on PA benefits and risks (26% [CI: 23-28%]). This one-day workshop had a positive impact on the knowledge gain of MD's on the topic of PA prescription. Although all groups of specialties increased knowledge, GPs and family medicine MDs benefited the most. This short course is an effective continuing education strategy for teaching PA assessment, counseling and prescription to MDs in Latin America, a topic rarely included in the training of MD's in the region and the world. Further follow-up is needed to ascertain impact on PA counseling practices.
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Monden, Rei; de Vos, Stijn; Morey, Richard; Wagenmakers, Eric-Jan; de Jonge, Peter; Roest, Annelieke M
2016-12-01
The Food and Drug Administration (FDA) uses a p < 0.05 null-hypothesis significance testing framework to evaluate "substantial evidence" for drug efficacy. This framework only allows dichotomous conclusions and does not quantify the strength of evidence supporting efficacy. The efficacy of FDA-approved antidepressants for the treatment of anxiety disorders was re-evaluated in a Bayesian framework that quantifies the strength of the evidence. Data from 58 double-blind placebo-controlled trials were retrieved from the FDA for the second-generation antidepressants for the treatment of anxiety disorders. Bayes factors (BFs) were calculated for all treatment arms compared to placebo and were compared with the corresponding p-values and the FDA conclusion categories. BFs ranged from 0.07 to 131,400, indicating a range of no support of evidence to strong evidence for the efficacy. Results also indicate a varying strength of evidence between the trials with p < 0.05. In sum, there were large differences in BFs across trials. Among trials providing "substantial evidence" according to the FDA, only 27 out of 59 dose groups obtained strong support for efficacy according to the typically used cutoff of BF ≥ 20. The Bayesian framework can provide valuable information on the strength of the evidence for drug efficacy. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
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Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.
Sage, Adam; Blalock, Susan J; Carpenter, Delesha
This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.
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Determination of radionuclides in foods from Minsk, Belarus, from Chernobyl to the present
NASA Astrophysics Data System (ADS)
Baratta, E. J.
2003-01-01
The U.S. Food and Drug Administration (FDA) are responsible for the wholesomeness of the food supply in the United States (US). The FDA has been monitoring the food supply in the United States for radioactivity since 1961, because of the Fallout generated by above the ground testing in the early 60’s. This Radionuclide in Foods Program is maintained to allow the FDA to respond to any nuclear emergency that may affect the food supply. The Three Mile Island incident in 1979 was one of these. In 1986 the Chernobyl incident occurred. As a result, the FDA began extensive monitoring of imported foods, especially those from Europe. One of its sister agencies has personnel in the areas effected by the latter incident and requested that the FDA analyze selected food samples from these places. Since that time, they have requested on a periodic basis, selected food samples be analysed. One such city was Minsk in Belarus. This paper will discuss the radionuclides of interest such as iodine-131, cesium-134/137, strontium-90, ruthenium-106 and other short-lived ones. It will discuss the types of foods sampled and the methodology used in determining the concentrations found in these items. The results will be compared to the permissible levels allowed in the US. In addition it will show the lower limits of detection for each of the radionuclides of interest.
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Amiera, Z Umi Romaizatul; Nihayah, M; Wahida, I Farah; Rajab, N F
2014-09-01
Ficus deltoidea is traditionally consumed by Malay woman to augment labour and hastening parturition. This study was to investigate the phytochemical present and uterotonic activity of F. deltoidea var. Deltoidea (FDD) and F. deltoidea var. Angustifolia (FDA) leaves aqueous extract. FDD and FDA were qualitatively analysed. In uterine contraction activity, adult female Sprague Dawley rats were pretreated with 0.2 mg kg(-1) diethylstilbestrol 24 h to induce oestrus phase. The rats then killed and uterine horns were taken out, cut into two centimetres length and put into organ bath that connected to Powerlab instrument. The uterus separately tested with cumulative concentrations of FDD (10-1280 μg mL(-1)), FDA (10-1280 μg mL(-1)), oxytocin (0.02-0.64 μg mL(-1)) and combination of oxytocin (0.08 μg mL(-1)) with FDD and FDA (10-1280 μg mL(-1)). FDD showed presence of flavonoid, saponin and tannin meanwhile FDA consist of flavonoid, tannin and terpenoid. Result showed FDD, FDA and oxytocin induced a dose-related increase in force of contraction of isolated rat uterus. The maximum uterine contraction (Emax) produced by FDD, FDA and oxytocin were at the concentration 640 μg mL(-1) (EC50, 5.903 ± 0.529 μg mL), 20 μg mL(-1) (EC50, 290.5 ± 0.158 μg mL(-1)) and 0.4 μg mL(-1) (EC50, 0.060 ± 0.011 μg mL(-1)) respectively. Combination effects of oxytocin with FDD and FDA produced Emax at the concentration 80 μg mL(-1) (EC50, 270.3 ± 0.643 μg mL(-1)) and 1280 μg mL(-1) (EC50, 26.83 ± 0.727 μg mL(-1)), respectively. Study indicated F. deltoidea possess contractile effect on uterine contraction. This plant has great potential to develop as natural uterotonic agent in inducing labour and treatment for post-partum haemorrhage.
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Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane
2013-03-11
Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through additional research prior to any FDA regulatory submission, although the NDDI-E was designed as a screening tool and is therefore unlikely to be suitable as an instrument for capturing change in a clinical trial and the SHE lacks the conceptual focus on signs and symptoms favoured by the FDA.
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2. View looking southeast at north and west facades of ...
2. View looking southeast at north and west facades of Test Stand 'D' workshop 4222/E-23, with Test Stand 'D' tower in background and tunnel access shed to the right. Equipment on 4222/E-23 roof is for air conditioning. - Jet Propulsion Laboratory Edwards Facility, Test Stand D, Workshop, Edwards Air Force Base, Boron, Kern County, CA
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1. View looking northeast at the west and south facades ...
1. View looking northeast at the west and south facades of Test Stand 'D' workshop 4222/E-23. Test Stand 'D' tower nitrogen tanks, television camera platform and access stairs are at right of image. Ductwork atop roof is for air conditioning system. - Jet Propulsion Laboratory Edwards Facility, Test Stand D, Workshop, Edwards Air Force Base, Boron, Kern County, CA
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Progeny testing: proceedings of servicewide genetics workshop
Dick Miller
1984-01-01
The primary objective of this workshop was to discuss in detail the state- of-the-art of progeny testing. All aspects, from setting objectives through data collection and analysis, was be covered. We all know progeny testing is a highly technical phase of our tree improvement programs. Each task is critical and must be performed accurately and within a prescribed time...
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Results on the Slosson Drawing Coordination Test with Appalachian Sheltered Workshop Clients.
ERIC Educational Resources Information Center
Rogers, George W., Jr.; Richmond, Bert O.
Fifty-four clients (13- to 52-years-old) in an Appalachian sheltered workshop were administered the Slosson Drawing Coordination Test (SDCT) and the Bender Visual Motor Gestalt Test. Twenty-nine Ss were labeled possibly brain damaged by the SDCT, and 17 Ss by the M. Hutt scoring system for the Bender-Gestalt. Two psychologists using all available…
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Stumbo, Phyllis J.; Weiss, Rick; Newman, John W.; Pennington, Jean A.; Tucker, Katherine L.; Wiesenfeld, Paddy L.; Illner, Anne-Kathrin; Klurfeld, David M.; Kaput, Jim
2010-01-01
Food intake, physical activity (PA), and genetic makeup each affect health and each factor influences the impact of the other 2 factors. Nutrigenomics describes interactions between genes and environment. Knowledge about the interplay between environment and genetics would be improved if experimental designs included measures of nutrient intake and PA. Lack of familiarity about how to analyze environmental variables and ease of access to tools and measurement instruments are 2 deterrents to these combined studies. This article describes the state of the art for measuring food intake and PA to encourage researchers to make their tools better known and more available to workers in other fields. Information presented was discussed during a workshop on this topic sponsored by the USDA, NIH, and FDA in the spring of 2009. PMID:20980656
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Fourteenth workshop geothermal reservoir engineering: Proceedings
DOE Office of Scientific and Technical Information (OSTI.GOV)
Ramey, H.J. Jr.; Kruger, P.; Horne, R.N.
1989-01-01
The Fourteenth Workshop on Geothermal Reservoir Engineering was held at Stanford University on January 24--26, 1989. Major areas of discussion include: (1) well testing; (2) various field results; (3) geoscience; (4) geochemistry; (5) reinjection; (6) hot dry rock; and (7) numerical modelling. For these workshop proceedings, individual papers are processed separately for the Energy Data Base.
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Fourteenth workshop geothermal reservoir engineering: Proceedings
DOE Office of Scientific and Technical Information (OSTI.GOV)
Ramey, H.J. Jr.; Kruger, P.; Horne, R.N.
The Fourteenth Workshop on Geothermal Reservoir Engineering was held at Stanford University on January 24--26, 1989. Major areas of discussion include: (1) well testing; (2) various field results; (3) geoscience; (4) geochemistry; (5) reinjection; (6) hot dry rock; and (7) numerical modelling. For these workshop proceedings, individual papers are processed separately for the Energy Data Base.
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The Development and Field Testing of Evaluation Workshop I: An Orientation.
ERIC Educational Resources Information Center
Klein, Stephen P.; Nadeau, Marc-Andre
The general purpose of an evaluation workshop is to orient school and state department of education personnel to the basic principles, procedures, and problems associated with evaluating educational programs and to the kinds of information an evaluation can provide for educational decision making. The workshop studied is based on the general…
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Texas Water Quality Board Teachers Workshop Program.
ERIC Educational Resources Information Center
Texas Water Quality Board, Austin.
These materials are designed for teachers participating in an inservice workshop on water quality. Included in the materials are a workshop agenda, a water awareness pretest, and the various parameters and tests that are used to determine and measure water quality. The parameters are discussed from the standpoint of their potential impact to…
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2017 Marine Hydrokinetic Instrumentation Workshop Report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Driscoll, Frederick R; Mauer, Erik; Rieks, Jeff
The third Marine Hydrokinetic Instrumentation Workshop was held at Florida Atlantic University's Sea Tech Campus in Dania Beach, Florida, from February 28 to March 1, 2017. The workshop brought together 37 experts in marine energy measurement, testing, and technology development to present and discuss the instrumentation and data-processing needs of the marine energy industry. The workshop was comprised of a plenary session followed by two focused breakout sessions. The half-day plenary session reviewed findings from prior instrumentation workshops, presented research activities that aim to fill previously identified gaps, and had industry experts present the state of the marine energy measurementmore » technologies. This report provides further detail on the workshop, objectives, and findings.« less
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Test results were obtained in accordance with ISO (International Organization for Standardization) IWA (International Workshop Agreement) 11:2012 that was unanimously affirmed by more than 90 stakeholders at the ISO International Workshop on Cookstoves on February 28-29, 2012 in ...
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Test results were obtained in accordance with ISO (International Organization for Standardization) IWA (International Workshop Agreement) 11:2012 that was unanimously affirmed by more than 90 stakeholders at the ISO International Workshop on Cookstoves on February 28-29, 2012 in ...
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ERIC Educational Resources Information Center
California Univ., Los Angeles. Center for the Study of Evaluation.
This participant's handbook is designed to be used in conjunction with a workshop for planning bilingual student assessment. The following materials are included: (1) simulation materials, including descriptions of simulated programs, tests, test manuals, and printouts; (2) checklists, diagrams, and charts illustrating important points of the…
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Minorities and Women in Educational Research: Progress Toward Equality. Final Report.
ERIC Educational Resources Information Center
American Educational Research Association, Washington, DC.
This report evaluates a project to pilot-test workshop materials designed to facilitate increased participation of women and minorities in educational research and development. The pilot test involved three NIE/AERA sponsored workshops organized in conjunction with the 1980 annual meeting of the American Educational Research Association. The…
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Test results were obtained in accordance with ISO (International Organization for Standardization) IWA (International Workshop Agreement) 11:2012 that was unanimously affirmed by more than 90 stakeholders at the ISO International Workshop on Cookstoves on February 28-29, 2012 in ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-17
... [Docket No. FDA-2011-N-0449] SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the... testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and... techniques, when appropriate, and other forms of information technology. SPF Labeling and Testing...
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LAVA Simulations for the AIAA Sonic Boom Prediction Workshop
NASA Technical Reports Server (NTRS)
Housman, Jeffrey A.; Sozer, Emre; Moini-Yekta , Shayan; Kiris, Cetin C.
2014-01-01
Computational simulations using the Launch Ascent and Vehicle Aerodynamics (LAVA) framework are presented for the First AIAA Sonic Boom Prediction Workshop test cases. The framework is utilized with both structured overset and unstructured meshing approaches. The three workshop test cases include an axisymmetric body, a Delta Wing-Body model, and a complete low-boom supersonic transport concept. Solution sensitivity to mesh type and sizing, and several numerical convective flux discretization choices are presented and discussed. Favorable comparison between the computational simulations and experimental data of nearand mid-field pressure signatures were obtained.
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Developing workshop module of realistic mathematics education: Follow-up workshop
NASA Astrophysics Data System (ADS)
Palupi, E. L. W.; Khabibah, S.
2018-01-01
Realistic Mathematics Education (RME) is a learning approach which fits the aim of the curriculum. The success of RME in teaching mathematics concepts, triggering students’ interest in mathematics and teaching high order thinking skills to the students will make teachers start to learn RME. Hence, RME workshop is often offered and done. This study applied development model proposed by Plomp. Based on the study by RME team, there are three kinds of RME workshop: start-up workshop, follow-up workshop, and quality boost. However, there is no standardized or validated module which is used in that workshops. This study aims to develop a module of RME follow-up workshop which is valid and can be used. Plopm’s developmental model includes materials analysis, design, realization, implementation, and evaluation. Based on the validation, the developed module is valid. While field test shows that the module can be used effectively.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Molecke, M.A.; Sorensen, N.R.; Wicks, G.G.
The three papers in this report were presented at the second international workshop to feature the Waste Isolation Pilot Plant (WIPP) Materials Interface Interactions Test (MIIT). This Workshop on In Situ Tests on Radioactive Waste Forms and Engineered Barriers was held in Corsendonk, Belgium, on October 13--16, 1992, and was sponsored by the Commission of the European Communities (CEC). The Studiecentrum voor Kernenergie/Centre D`Energie Nucleaire (SCK/CEN, Belgium), and the US Department of Energy (via Savannah River) also cosponsored this workshop. Workshop participants from Belgium, France, Germany, Sweden, and the United States gathered to discuss the status, results and overviews ofmore » the MIIT program. Nine of the twenty-five total workshop papers were presented on the status and results from the WIPP MIIT program after the five-year in situ conclusion of the program. The total number of published MIIT papers is now up to almost forty. Posttest laboratory analyses are still in progress at multiple participating laboratories. The first MIIT paper in this document, by Wicks and Molecke, provides an overview of the entire test program and focuses on the waste form samples. The second paper, by Molecke and Wicks, concentrates on technical details and repository relevant observations on the in situ conduct, sampling, and termination operations of the MIIT. The third paper, by Sorensen and Molecke, presents and summarizes the available laboratory, posttest corrosion data and results for all of the candidate waste container or overpack metal specimens included in the MIIT program.« less
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Evaluation of the Affymetrix CytoScan® Dx Assay for Developmental Delay
Webb, Bryn D.; Scharf, Rebecca J.; Spear, Emily A.; Edelmann, Lisa J.; Stroustrup, Annemarie
2015-01-01
The goal of molecular cytogenetic testing for children presenting with developmental delay is to identify or exclude genetic abnormalities that are associated with cognitive, behavioral, and/or motor symptoms. Until 2010, chromosome analysis was the standard first-line genetic screening test for evaluation of patients with developmental delay when a specific syndrome was not suspected. In 2010, The American College of Medical Genetics and several other groups recommended chromosomal microarray (CMA) as the first-line test in children with developmental delays, multiple congenital anomalies, and/or autism. This test is able to detect regions of genomic imbalances at a much finer resolution than G-banded karyotyping. Until recently, no CMA testing had been approved by the United States Food and Drug Administration (FDA). This review will focus on the use of the Affymetrix CytoScan® Dx Assay, the first CMA to receive FDA approval for the genetic evaluation of individuals with developmental delay. PMID:25350348
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European and Mexican vs US diagnostic extracts of Bermuda grass and cat in skin testing.
Larenas-Linnemann, Désirée; Cruz, Alfredo Arias; Gutierrez, Isabel Rojo; Rodriguez, Pablo; Shah-Hosseini, Kijawasch; Michels, Alexandra; Mösges, Ralph
2011-05-01
Laboratory testing of various diagnostic extracts has shown lower potencies for several European and Mexican extracts relative to the US Food and Drug Administration (FDA) reference (10,000 BAU/mL). Quantitative skin prick testing (QSPT) with Dermatophagoides pteronyssinus extracts have previously shown a similar picture. To compare European and Mexican Bermuda grass (BG) and cat diagnostic extracts against an FDA-validated extract using QSPT. Six diagnostic BG and cat extracts (1 reference FDA extract, 3 European extracts, 1 imported nonstandardized extract from the United States, and 1 Mexican extract) were tested with quadruplicate QSPT, as a concentrate and as 2 serial 2-fold dilutions, in cat and BG allergic individuals. BG showed good dose response in wheal size for the concentrate (1:2-1:4 dilutions; steep part of the curve). Cat showed poorer dose response. The Wilcoxon test for linked random samples was used to investigate whether the distribution of the reference differed from each of the test extracts to a statistically significant degree (2-sided asymptotic significance, α = .05). All BG and 2 cat extracts were statistically less potent than the 10,000 BAU/mL US reference. European BG extracts were 7,700, 4,100, and 1,600 BAU/mL, and cat extracts were 12,500, 4,400, and 5,100 BAU/mL. The potency of some diagnostic extracts of BG and cat used in Europe, Mexico, and the United States differs, with the US extracts being generally more potent. On the basis of provocation tests, optimal diagnostic concentrations should be determined. Similar comparisons using other manufacturers and therapeutic extracts might be interesting. Copyright © 2011 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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MacIntyre, Hugh L; Cullen, John J
2016-08-01
Regulations for ballast water treatment specify limits on the concentrations of living cells in discharge water. The vital stains fluorescein diacetate (FDA) and 5-chloromethylfluorescein diacetate (CMFDA) in combination have been recommended for use in verification of ballast water treatment technology. We tested the effectiveness of FDA and CMFDA, singly and in combination, in discriminating between living and heat-killed populations of 24 species of phytoplankton from seven divisions, verifying with quantitative growth assays that uniformly live and dead populations were compared. The diagnostic signal, per-cell fluorescence intensity, was measured by flow cytometry and alternate discriminatory thresholds were defined statistically from the frequency distributions of the dead or living cells. Species were clustered by staining patterns: for four species, the staining of live versus dead cells was distinct, and live-dead classification was essentially error free. But overlap between the frequency distributions of living and heat-killed cells in the other taxa led to unavoidable errors, well in excess of 20% in many. In 4 very weakly staining taxa, the mean fluorescence intensity in the heat-killed cells was higher than that of the living cells, which is inconsistent with the assumptions of the method. Applying the criteria of ≤5% false negative plus ≤5% false positive errors, and no significant loss of cells due to staining, FDA and FDA+CMFDA gave acceptably accurate results for only 8-10 of 24 species (i.e., 33%-42%). CMFDA was the least effective stain and its addition to FDA did not improve the performance of FDA alone. © 2016 The Authors. Journal of Phycology published by Wiley Periodicals, Inc. on behalf of Phycological Society of America.
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NASA Astrophysics Data System (ADS)
Constantinescu, C. C.; Yoder, K. K.; Kareken, D. A.; Bouman, C. A.; O'Connor, S. J.; Normandin, M. D.; Morris, E. D.
2008-03-01
We previously developed a model-independent technique (non-parametric ntPET) for extracting the transient changes in neurotransmitter concentration from paired (rest & activation) PET studies with a receptor ligand. To provide support for our method, we introduced three hypotheses of validation based on work by Endres and Carson (1998 J. Cereb. Blood Flow Metab. 18 1196-210) and Yoder et al (2004 J. Nucl. Med. 45 903-11), and tested them on experimental data. All three hypotheses describe relationships between the estimated free (synaptic) dopamine curves (FDA(t)) and the change in binding potential (ΔBP). The veracity of the FDA(t) curves recovered by nonparametric ntPET is supported when the data adhere to the following hypothesized behaviors: (1) ΔBP should decline with increasing DA peak time, (2) ΔBP should increase as the strength of the temporal correlation between FDA(t) and the free raclopride (FRAC(t)) curve increases, (3) ΔBP should decline linearly with the effective weighted availability of the receptor sites. We analyzed regional brain data from 8 healthy subjects who received two [11C]raclopride scans: one at rest, and one during which unanticipated IV alcohol was administered to stimulate dopamine release. For several striatal regions, nonparametric ntPET was applied to recover FDA(t), and binding potential values were determined. Kendall rank-correlation analysis confirmed that the FDA(t) data followed the expected trends for all three validation hypotheses. Our findings lend credence to our model-independent estimates of FDA(t). Application of nonparametric ntPET may yield important insights into how alterations in timing of dopaminergic neurotransmission are involved in the pathologies of addiction and other psychiatric disorders.
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Burton, J H; Stanley, S D; Knych, H K; Rodriguez, C O; Skorupski, K A; Rebhun, R B
2016-01-01
Compounded lomustine is used commonly in veterinary patients. However, the potential variability in these formulations is unknown and concern exists that compounded formulations of drugs may differ in potency from Food and Drug Administration (FDA)-approved products. The initial objective of this study was to evaluate the frequency and severity of neutropenia in dogs treated with compounded or FDA-approved formulations of lomustine. Subsequent analyses aimed to determine the potency of lomustine obtained from several compounding pharmacies. Thirty-seven dogs treated with FDA-approved or compounded lomustine. Dogs that received compounded or FDA-approved lomustine and had pretreatment and nadir CBCs performed were eligible for inclusion. Variables assessed included lomustine dose, neutrophil counts, and severity of neutropenia. Lomustine 5 mg capsules from 5 compounding sources were tested for potency using high-pressure liquid chromatography (HPLC) with ultraviolet (UV) detection. Twenty-one dogs received FDA-approved lomustine and 16 dogs were treated with lomustine prescribed from a single compounding pharmacy. All dogs treated with FDA-approved lomustine were neutropenic after treatment; 15 dogs (71%) developed grade 3 or higher neutropenia. Four dogs (25%) given compounded lomustine became neutropenic, with 2 dogs (12.5%) developing grade 3 neutropenia. The potency of lomustine from 5 compounding pharmacies ranged from 50 to 115% of the labeled concentration, with 1 sample within ±10% of the labeled concentration. These data support broader investigation into the potency and consistency of compounded chemotherapy drugs and highlight the potential need for greater oversight of these products. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
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First International Workshop on Grid Simulator Testing of Wind Turbine
of Wind Turbine Drivetrains First International Workshop on Grid Simulator Testing of Wind Turbine Wind Turbine Drivetrains June 13-14, 2013, at the National Wind Technology Center near Boulder apparatuses involved in grid compliance testing of utility-scale wind turbine generators. This includes both
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Performance of Cleared Blood Glucose Monitors.
Klonoff, David C; Prahalad, Priya
2015-07-01
Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). We found 11 publications describing performance of 98 unique BGM systems. 53 of these 98 (54%) systems met ISO 15197 2003 and 31 of the 98 (32%) tested systems met ISO 15197 2013 analytical accuracy standards in all studies in which they were evaluated. Of the tested systems, 33 were identified by us as FDA-cleared. Among these FDA-cleared BGM systems, 24 out of 32 (75%) met ISO 15197 2003 and 15 out of 31 (48.3%) met ISO 15197 2013 in all studies in which they were evaluated. Among the non-FDA-cleared BGM systems, 29 of 65 (45%) met ISO 15197 2003 and 15 out of 65 (23%) met ISO 15197 2013 in all studies in which they were evaluated. It is more likely that an FDA-cleared BGM system, compared to a non-FDA-cleared BGM system, will perform according to ISO 15197 2003 (χ(2) = 6.2, df = 3, P = 0.04) and ISO 15197 2013 (χ(2) = 11.4, df = 3, P = 0.003). We identified 7 articles about clinical risks and 3 articles about economic risks of inaccurate BGMs. We conclude that a significant proportion of cleared BGMs do not perform at the level for which they were cleared or according to international standards of accuracy. Such poor performance leads to adverse clinical and economic consequences. © 2015 Diabetes Technology Society.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...
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Emotional intelligence and coping styles: An intervention in geriatric nurses.
Sarabia-Cobo, Carmen María; Suárez, Soraya González; Menéndez Crispín, Ernesto J; Sarabia Cobo, A Belén; Pérez, Victoria; de Lorena, Pablo; Rodríguez Rodríguez, Cristina; Sanlúcar Gross, Laura
2017-06-01
Current research indicates a relationship between EI, stress, coping strategies, well-being and mental health. Emotional intelligence skills and knowledge, and coping strategies can be increased with training. The aims of this study were to use a controlled design to test the impact of theoretically based training on the different components of EI and coping styles in a sample of nurses working with older adults. A group of 92 professionals (RN and CAN) who attended a workshop on EI were included in the study. They completed a self-reported measure of EI and coping styles on three occasions: pre- and post-workshop and at one year follow-up. The EI workshop consisted of four 4-h sessions conducted over a four-week period. Each session was held at the one-week interval. This interval allowed participants to apply what was taught during the session to their daily life. The instruments to measure the EI and coping were the Trait Meta-Mood Scale and the CAE test. There were significant differences between the pre- and post-workshop measures both at the end of the workshop and up to one year for both the Trait Meta-Mood Scale scores and the CAE test. There was a significant increase in the EI and coping styles after the workshop and one year thereafter. The workshop was useful for developing EI in the professionals. The immediate impact of the emotional consciousness of individuals was particularly significant for all participants. The long-term impact was notable for the significant increase in EI and most coping styles. Copyright © 2017 Elsevier Inc. All rights reserved.
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"Don't Forget Your Leech Socks"! Children's Learning during an Eden Education Officer's Workshop
ERIC Educational Resources Information Center
Bowker, Rob; Jasper, Andy
2007-01-01
This study looked at 30 primary aged children between 10 and 11 years old who were visiting the Eden Project, Cornwall and participating in workshops led and designed by the Eden Education Officers. The study attempted to directly test the effects of the Education Officers' workshops on children's learning. Personal meaning mapping, a…
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ERIC Educational Resources Information Center
Morris, Lisa
2012-01-01
Master teacher Lisa Morris invites you to share her secrets of success with writer's workshops. After years of experimenting with the workshop model, she has developed the most effective ways to apply it in the classroom, yielding higher test scores and increased student engagement. Through practical, step-by-step instruction, Morris demonstrates…
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Modified Composite Materials Workshop
NASA Technical Reports Server (NTRS)
Dicus, D. L. (Compiler)
1978-01-01
The reduction or elimination of the hazard which results from accidental release of graphite fibers from composite materials was studied at a workshop. At the workshop, groups were organized to consider six topics: epoxy modifications, epoxy replacement, fiber modifications, fiber coatings and new fibers, hybrids, and fiber release testing. Because of the time required to develop a new material and acquire a design data base, most of the workers concluded that a modified composite material would require about four to five years of development and testing before it could be applied to aircraft structures. The hybrid working group considered that some hybrid composites which reduce the risk of accidental fiber release might be put into service over the near term. The fiber release testing working group recommended a coordinated effort to define a suitable laboratory test.
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Rosenberg, Amy S; Cherney, Barry; Brorson, Kurt; Clouse, Kathleen; Kozlowski, Steven; Hughes, Patricia; Friedman, Rick
2011-01-01
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Viral contamination of biotech product facilities is a potentially devastating manufacturing risk and, unfortunately, is more common than is generally reported or previously appreciated. Although viral contaminants of biotech products are thought to originate principally from biological raw materials, all potential process risks merit evaluation. Limitations to existing methods for virus detection are becoming evident as emerging viruses have contaminated facilities and disrupted supplies of critical products. New technologies, such as broad-based polymerase chain reaction screens for multiple virus types, are increasingly becoming available to detect adventitious viral contamination and thus, mitigate risks to biotech products and processes. Further, the industry embrace of quality risk management that promotes improvements in testing stratagems, enhanced viral inactivation methods for raw materials, implementation and standardization of robust viral clearance procedures, and efforts to learn from both epidemiologic screening of raw material sources and from the experience of other manufacturers with regard to this problem will serve to enhance the safety of biotech products available to patients. Based on this evolving landscape, we propose a set of principles for manufacturers of biotech products: Pillars of Risk Mitigation for Viral Contamination of Biotech Products.
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The 1979 Goddard Space Flight Center Battery Workshop
NASA Technical Reports Server (NTRS)
Halpert, G. (Editor)
1980-01-01
Papers discussing the latest results of testing, analysis, and development of the sealed nickel cadmium cell system are presented. Metal hydrogen and lithium cell technology and applications are also discussed. The purpose of the workshop was to share flight and test experience, stimulate discussion on problem areas, and to review the latest technology improvements.
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Field Testing Vocational Education Metric Modules. Final Report.
ERIC Educational Resources Information Center
Oldsen, Carl F.
A project was conducted for the following purposes: (1) to develop a workshop training package to prepare vocational education teachers to use vocational subject-specific modules; (2) to train those teachers to use the workshop package; (3) to conduct field tests of the metric modules with experimental and control groups; (4) to analyze, describe,…
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WE-AB-206-00: Diagnostic QA/QC Hands-On Workshop
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
The involvement of medical physicists in diagnostic ultrasound imaging service is increasing due to QC and accreditation requirements. The goal of this ultrasound hands-on workshop is to demonstrate quality control (QC) testing in diagnostic ultrasound and to provide updates in ACR ultrasound accreditation requirements. The first half of this workshop will include two presentations reviewing diagnostic ultrasound QA/QC and ACR ultrasound accreditation requirements. The second half of the workshop will include live demonstrations of basic QC tests. An array of ultrasound testing phantoms and ultrasound scanners will be available for attendees to learn diagnostic ultrasound QC in a hands-on environmentmore » with live demonstrations and on-site instructors. The targeted attendees are medical physicists in diagnostic imaging. Learning Objectives: Gain familiarity with common elements of a QA/QC program for diagnostic ultrasound imaging dentify QC tools available for testing diagnostic ultrasound systems and learn how to use these tools Learn ACR ultrasound accreditation requirements Jennifer Walter is an employee of American College of Radiology on Ultrasound Accreditation.« less
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Statistical Analysis of CFD Solutions from the 6th AIAA CFD Drag Prediction Workshop
NASA Technical Reports Server (NTRS)
Derlaga, Joseph M.; Morrison, Joseph H.
2017-01-01
A graphical framework is used for statistical analysis of the results from an extensive N- version test of a collection of Reynolds-averaged Navier-Stokes computational uid dynam- ics codes. The solutions were obtained by code developers and users from North America, Europe, Asia, and South America using both common and custom grid sequencees as well as multiple turbulence models for the June 2016 6th AIAA CFD Drag Prediction Workshop sponsored by the AIAA Applied Aerodynamics Technical Committee. The aerodynamic con guration for this workshop was the Common Research Model subsonic transport wing- body previously used for both the 4th and 5th Drag Prediction Workshops. This work continues the statistical analysis begun in the earlier workshops and compares the results from the grid convergence study of the most recent workshop with previous workshops.
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Recent strategies for drug development in fibromyalgia syndrome.
Blumenthal, David E; Malemud, Charles J
2016-12-01
The US Federal Drug Administration (FDA) approved 3 medications for treating fibromyalgia syndrome (FMS). There have been no additional FDA approvals since January 2009 and the efficacy of the FDA-approved medications for FMS has been questioned. Areas covered: The "search for studies" tool using clinicaltrials.gov and PubMed were employed. The term, "fibromyalgia" was used for clinicaltrials.gov. The terms employed for PubMed were "Name-of-Drug Fibromyalgia", "Fibromyalgia Treatment" or "Fibromyalgia Drug Treatment." Clinical trials were reviewed if they were prospective and blinded, and if they employed a comparator, either placebo or another pharmaceutical. Expert commentary: Progress toward standardizing the outcome measures for FMS clinical trials have been made but challenges remain. Several pharmaceutical candidates for FMS have been tested since 2009. The results of these studies with potential novel targets for drug development for FMS were reviewed including the results of trials with sodium oxybate, quetiapine, esreboxetine, nabilone, memantine, naltrexone, and melatonin.
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Bhansali, Archita H; Sangani, Darshan S; Mhatre, Shivani K; Sansgiry, Sujit S
2018-01-01
To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students. University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010. A current FDA label was compared to two experimental labels developed using the theory of CHREST to test information processing by re-positioning the warning information within the Drug Facts panel. Congruency was defined as placing like information together. Information processing was evaluated using the OTC medication Label Evaluation Process Model (LEPM): label comprehension, ease-of-use, attitude toward the product, product evaluation, and purchase intention. Experimental label with chunked congruent information (uses-directions-other information-warnings) was rated significantly higher than the current FDA label and had the best average scores among the LEPM information processing variables. If replications uphold these findings, the FDA label design might be revised to improve information processing.
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Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana
2015-01-01
The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.
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Occurrence and methods of control of chemical contaminants in foods.
Jelinek, C
1981-06-01
Contamination of food by chemicals can result from their use on agricultural commodities; accidents or misuse during food handling and processing; nucler weapon testing and operation of nuclear power plants; and disposal of industrial chemicals or by-products with subsequent dispersal into the environment. The Food and Drug Administration (FDA), as the Federal agency mainly responsible for evaluating the hazards of chemical contaminants and enforcing any established tolerance levels for them in foods, has been monitoring pesticides, industrial chemicals, metals, and radionuclides in foods in its nationwide programs for many years. In addition, FDA searches for potential contaminants among the approximately 50,000 industrial chemicals manufactured in the United States and coordinates its efforts with those of other Federal and state agencies in these investigations. The overall results of the FDA surveillance and compliance programs for chemical contaminants in foods, as well as specific examples illustrating the wide range of incidents and types of occurrences, are presented.
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Stang, Paul E; Ryan, Patrick B; Racoosin, Judith A; Overhage, J Marc; Hartzema, Abraham G; Reich, Christian; Welebob, Emily; Scarnecchia, Thomas; Woodcock, Janet
2010-11-02
The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-07
..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability...\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...
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Applying radio-frequency identification (RFID) technology in transfusion medicine.
Hohberger, Clive; Davis, Rodeina; Briggs, Lynne; Gutierrez, Alfonso; Veeramani, Dhamaraj
2012-05-01
ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
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Burmeister Getz, E; Carroll, K J; Mielke, J; Benet, L Z; Jones, B
2017-03-01
We previously demonstrated pharmacokinetic differences among manufacturing batches of a US Food and Drug Administration (FDA)-approved dry powder inhalation product (Advair Diskus 100/50) large enough to establish between-batch bio-inequivalence. Here, we provide independent confirmation of pharmacokinetic bio-inequivalence among Advair Diskus 100/50 batches, and quantify residual and between-batch variance component magnitudes. These variance estimates are used to consider the type I error rate of the FDA's current two-way crossover design recommendation. When between-batch pharmacokinetic variability is substantial, the conventional two-way crossover design cannot accomplish the objectives of FDA's statistical bioequivalence test (i.e., cannot accurately estimate the test/reference ratio and associated confidence interval). The two-way crossover, which ignores between-batch pharmacokinetic variability, yields an artificially narrow confidence interval on the product comparison. The unavoidable consequence is type I error rate inflation, to ∼25%, when between-batch pharmacokinetic variability is nonzero. This risk of a false bioequivalence conclusion is substantially higher than asserted by regulators as acceptable consumer risk (5%). © 2016 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of The American Society for Clinical Pharmacology and Therapeutics.
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Courtenay-Quirk, Cari; Spindler, Hilary; Leidich, Aimee; Bachanas, Pam
2016-12-01
Strategic, high quality HIV testing services (HTS) delivery is an essential step towards reaching the end of AIDS by 2030. We conducted HTS Data Use workshops in five African countries to increase data use for strategic program decision-making. Feedback was collected on the extent to which workshop skills and tools were applied in practice and to identify future capacity-building needs. We later conducted six semistructured phone interviews with workshop planning teams and sent a web-based survey to 92 past participants. The HTS Data Use workshops provided accessible tools that were readily learned by most respondents. While most respondents reported increased confidence in interpreting data and frequency of using such tools over time, planning team representatives indicated ongoing needs for more automated tools that can function across data systems. To achieve ambitious global HIV/AIDS targets, national decision makers may continue to seek tools and skill-building opportunities to monitor programs and identify opportunities to refine strategies.
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NASA Technical Reports Server (NTRS)
Tan, C. M.; Carr, L. W.
1996-01-01
A variety of empirical and computational fluid dynamics two-dimensional (2-D) dynamic stall models were compared to recently obtained three-dimensional (3-D) dynamic stall data in a workshop on modeling of 3-D dynamic stall of an unswept, rectangular wing, of aspect ratio 10. Dynamic stall test data both below and above the static stall angle-of-attack were supplied to the participants, along with a 'blind' case where only the test conditions were supplied in advance, with results being compared to experimental data at the workshop itself. Detailed graphical comparisons are presented in the report, which also includes discussion of the methods and the results. The primary conclusion of the workshop was that the 3-D effects of dynamic stall on the oscillating wing studied in the workshop can be reasonably reproduced by existing semi-empirical models once 2-D dynamic stall data have been obtained. The participants also emphasized the need for improved quantification of 2-D dynamic stall.
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NASA Technical Reports Server (NTRS)
Baize, Daniel G. (Editor)
1999-01-01
The High-Speed Research Program and NASA Langley Research Center sponsored the NASA High-Speed Research Program Sonic Boom Workshop on September 12-13, 1995. The workshop was designed to bring together NASAs scientists and engineers and their counterparts in industry, other Government agencies, and academia working together in the sonic boom element of NASAs High-Speed Research Program. Specific objectives of this workshop were to: (1) report the progress and status of research in sonic boom propagation, acceptability, and design; (2) promote and disseminate this technology within the appropriate technical communities; (3) help promote synergy among the scientists working in the Program; and (4) identify technology pacing, the development C, of viable reduced-boom High-Speed Civil Transport concepts. The Workshop was organized in four sessions: Sessions 1 Sonic Boom Propagation (Theoretical); Session 2 Sonic Boom Propagation (Experimental); Session 3 Acceptability Studies-Human and Animal; and Session 4 - Configuration Design, Analysis, and Testing.
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A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing.
Olia, Salim E; Herbertson, Luke H; Malinauskas, Richard A; Kameneva, Marina V
2017-02-01
Bench-top in vitro hemolysis testing is a fundamental tool during the design and regulatory safety evaluation of blood-contacting medical devices. While multiple published experimental protocols exist, descriptions of the test loop reservoir remain ambiguous. A critical fixture within the circuit, there is no readily available blood reservoir that ensures thorough mixing and complete air evacuation: two major factors which can affect results. As part of the Food and Drug Administration (FDA) Critical Path Initiative, we developed a three-piece reservoir consisting of a 3D-printed base, a plastic clamp set, and a medical-grade blood bag. This simple, reusable, and cost-effective design was used successfully in the hemolysis assessment of FDA benchmark nozzles and prototype rotary blood pumps, and may be useful as an integral component to any in vitro blood circulation loop. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
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Mars Sample Quarantine Protocol Workshop
NASA Technical Reports Server (NTRS)
DeVincenzi, Donald L. (Editor); Bagby, John (Editor); Race, Margaret (Editor); Rummel, John (Editor)
1999-01-01
The Mars Sample Quarantine Protocol (QP) Workshop was convened to deal with three specific aspects of the initial handling of a returned Mars sample: 1) biocontainment, to prevent uncontrolled release of sample material into the terrestrial environment; 2) life detection, to examine the sample for evidence of live organisms; and 3) biohazard testing, to determine if the sample poses any threat to terrestrial life forms and the Earth's biosphere. During the first part of the Workshop, several tutorials were presented on topics related to the workshop in order to give all participants a common basis in the technical areas necessary to achieve the objectives of the Workshop.
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Perceptions of the Food and Drug Administration as a Tobacco Regulator
Jarman, Kristen L.; Ranney, Leah M.; Baker, Hannah M.; Vallejos, Quirina M.; Goldstein, Adam O.
2017-01-01
Objectives The U. S. Food and Drug Administration (FDA) now has regulatory authority over all tobacco products. Little is known about public awareness and perceptions of FDA in their new role as a tobacco regulator. This research utilizes focus groups to examine perceptions of FDA as a tobacco regulator so that FDA can better communicate with the public about this role. Methods We conducted 6 focus groups in 2014 among a diverse sample of smokers and non-smokers. Participants were asked if they had heard of FDA, what they knew about FDA, if they associated FDA with tobacco, and their thoughts about this FDA role. Results A total of 41 individuals participated. Although nearly all participants had heard of FDA, most were not aware of FDA’s regulatory authority over tobacco products, did not associate the role of FDA with tobacco, and some drew comparisons between FDA’s work in tobacco and their work regulating food and drugs. Conclusion Data suggest that although public awareness of FDA regulatory authority over tobacco is low, with proper public education, the public may find FDA to be a trustworthy source of tobacco regulation. PMID:29051917
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Kumar, Dinesh; Singh, Uday Shankar; Solanki, Rajanikant
2015-07-01
Early undergraduate exposure to research helps in producing physicians who are better equipped to meet their professional needs especially the analytical skills. To assess the effectiveness and acceptability of small group method in teaching research methodology. Sixth semester medical undergraduates (III MBBS-part1) of a self-financed rural medical college. The workshop was of two full days duration consisting of daily two sessions by faculty for 30 minutes, followed by group activity of about four hours and presentation by students at the end of the day. A simple 8 steps approach was used. These steps are Identify a Problem, Refine the Problem, Determine a Solution, Frame the Question, Develop a Protocol, Take Action, Write the Report and Share your Experience. A Pre-test and post-test assessment was carried out using a questionnaire followed by anonymous feedback at the end of the workshop. The responses were evaluated by blinded evaluator. There were 95 (94.8%) valid responses out of the 99 students, who attended the workshop. The mean Pre-test and post-test scores were 4.21 and 10.37 respectively and the differences were found to be significant using Wilcoxon Sign Rank test (p<0.001). The median feedback score regarding relevance, skill learning, quality of facilitation, gain in knowledge was four and that of experience of group learning was 5 on a Likert scale of 1-5.There were no significant differences between male and female students in terms of Pre-test, post-test scores and overall gain in scores. Participatory research methodology workshop can play a significant role in teaching research to undergraduate students in an interesting manner. However, the long term effect of such workshops needs to be evaluated.
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Palos, Isidro; Lara-Ramirez, Edgar E; Lopez-Cedillo, Julio Cesar; Garcia-Perez, Carlos; Kashif, Muhammad; Bocanegra-Garcia, Virgilio; Nogueda-Torres, Benjamin; Rivera, Gildardo
2017-06-18
Chagas disease (CD) is a neglected disease caused by the parasite Trypanosoma cruzi , which affects underdeveloped countries. The current drugs of choice are nifurtimox and benznidazole, but both have severe adverse effects and less effectivity in chronic infections; therefore, the need to discover new drugs is essential. A computer-guided drug repositioning method was applied to identify potential FDA drugs (approved and withdrawn) as cruzain (Cz) inhibitors and trypanocidal effects were confirmed by in vitro and in vivo studies. 3180 FDA drugs were virtually screened using a structure-based approach. From a first molecular docking analysis, a set of 33 compounds with the best binding energies were selected. Subsequent consensus affinity binding, ligand amino acid contact clustering analysis, and ranked position were used to choose four known pharmacological compounds to be tested in vitro. Mouse blood samples infected with trypomastigotes from INC-5 and NINOA strains were used to test the trypanocidal effect of four selected compounds. Among these drugs, one fibrate antilipemic (etofyllin clofibrate) and three β-lactam antibiotics (piperacillin, cefoperazone, and flucloxacillin) showed better trypanocidal effects (LC 50 range 15.8-26.1 μg/mL) in comparison with benznidazole and nifurtimox (LC 50 range 33.1-46.7 μg/mL). A short-term in vivo evaluation of these compounds showed a reduction of parasitemia in infected mice (range 90-60%) at 6 h, but this was low compared to benznidazole (50%). This work suggests that four known FDA drugs could be used to design and obtain new trypanocidal agents.
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Mba-Jonas, Adamma; Culpepper, Wright; Hill, Thomas; Cantu, Venessa; Loera, Julie; Borders, Julie; Saathoff-Huber, Lori; Nsubuga, Johnson; Zambrana, Ingrid; Dalton, Shannon; Williams, Ian; Neil, Karen P
2018-05-17
Nontyphoidal Salmonella causes ~1 million food-borne infections annually in the United States. We began investigating a multistate outbreak of Salmonella serotype Agona infections in April 2011. A case was defined as infection with the outbreak strain of Salmonella Agona occurring between 1 January and 25 August 2011. We developed hypotheses through iterative interviews. Product distribution analyses and traceback investigations were conducted. The Food and Drug Administration (FDA) tested papayas from Mexico for Salmonella. We identified 106 case patients from 25 states. Their median age was 21 years (range, 1-91). Thirty-nine of 61 case patients (64%) reported Hispanic/Latino ethnicity; 11 of 65 (17%) travelled to Mexico before illness. Thirty-two of 56 case patients (57%) reported papaya consumption. Distribution analyses revealed that three firms, including Distributor A, distributed papaya to geographic areas that aligned with both the location and timing of illnesses. Traceback of papayas purchased by ill persons in four states identified Distributor A as the common supplier. FDA testing isolated the outbreak strain from a papaya sample collected at distributor A and from another sample collected at the US-Mexico border, destined for distributor A. FDA isolated Salmonella species from 62 of 388 papaya import samples (16%). The investigation led to a recall of fresh, whole papayas from Distributor A and an FDA import alert for all papayas from Mexico. This is the first reported Salmonella outbreak in the United States linked to fresh, whole papayas. The outbreak highlights important issues regarding the safety of imported produce.
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75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-21
... began prior to the availability of tests for HIV in early 1985. The deferral has existed in its current form since September 1985. This and other related FDA policies are designed to address the major... screened using highly sensitive tests, screening tests can be falsely negative during the ``window period...
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75 FR 39954 - Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-13
...] Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location AGENCY: Food and Drug... location for the upcoming public meeting entitled ``Oversight of Laboratory Developed Tests.'' A new... the public meeting, FDA is announcing in this notice a new location for the public meeting. II. New...
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ERIC Educational Resources Information Center
Stanger-Hall, Kathrin F.; Shockley, Floyd W.; Wilson, Rachel E.
2011-01-01
We implemented a "how to study" workshop for small groups of students (6-12) for N = 93 consenting students, randomly assigned from a large introductory biology class. The goal of this workshop was to teach students self-regulating techniques with visualization-based exercises as a foundation for learning and critical thinking in two areas:…
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ERIC Educational Resources Information Center
Nelson, Allan
2010-01-01
During laboratory sessions devoted to ecology, 182 preservice K-8 teachers participated in a Project Wildlife in Learning Design (WILD) workshop. Participants rated the workshop highly, indicated they would use more inquiry-based activities, and were more interested in teaching ecology following the workshop. Post-test scores indicated an…
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Toolkit for a Workshop on Building a Culture of Data Use. REL 2015-063
ERIC Educational Resources Information Center
Gerzon, Nancy; Guckenburg, Sarah
2015-01-01
The Culture of Data Use Workshop Toolkit helps school and district teams apply research to practice as they establish and support a culture of data use in their educational setting. The field-tested workshop toolkit guides teams through a set of structured activities to develop an understanding of data-use research in schools and to analyze…
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NASA Technical Reports Server (NTRS)
Johnson, W. Steven
1990-01-01
A workshop was held to help assess the state-of-the-art in evaluating the long term durability of polymeric matrix composites (PMCs) and to recommend future activities. Design and evaluation of PMCs at elevated temperatures were discussed. The workshop presentations, the findings of the workshop sessions are briefly summarized.
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Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J
This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units <905>, which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5 to 2.1 standard deviation (SD) of the percent label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3 to 9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting can have an effect on the amount of drug present in a split tablet and available for absorption. Tablet splitting has become a very common practice in the United States and throughout the world. Tablets are often split to modify dose strength, make swallowing easier, and reduce cost to the consumer. To better address product quality for this widely used practice, the U.S. Food and Drug Administration (FDA) published a Guidance for Industry that addresses tablet splitting. The guidance provides testing criteria for scored tablets, which is a part of the FDA review process for drugs. The model drugs selected for this study were amlodipine and gabapentin, which have different sizes, shapes, and tablet scores. Whole and split amlodipine tablets were tested for drug content because of a concern that the low-dose strength may cause greater variability. Whole and split gabapentin tablets were tested for weight variation because of their higher dosage strength of 600 mg. All whole tablets met the acceptance criteria for the Uniformity of Dosage Units based on the guidance recommendations. When unscored amlodipine tablets were split by a splitter, all formulations did not meet the acceptance criteria. When fully scored gabapentin tablets were split by hand and by splitter, they met the acceptance criteria. The findings of this FDA study indicated physical characteristics such as size, shape, and tablet score can affect the uniformity of split tablets. © PDA, Inc. 2016.
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NASA Technical Reports Server (NTRS)
French, Scott W.
1991-01-01
The goals are to show that verifying and validating a software system is a required part of software development and has a direct impact on the software's design and structure. Workshop tasks are given in the areas of statistics, integration/system test, unit and architectural testing, and a traffic controller problem.
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Chen, D; Wu, T; Yuan, Y
1996-11-01
To investigate the existence of the non-species specific antibody in plasma of the employees working in an automobile engine testing workshop, and to use it as a scanning marker of various hazards, the heat-stress protein antigen method and western blot technique were used. This study showed that employees working in the automoblile engine testing workshop were affected by various hazards, such as noise, toxic chemicals (carbon monoxide, lead fume, benzene, and so on), and there existed non-species specific antibodies against protein 103,900 and 54,200 of rat liver in their plasma, which were postulated as the specific products produced by exposure to occupational hazards, such as noise, carbon monoxide, et al.
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The Regulatory Evaluation of Vaccines for Human Use.
Baylor, Norman W
2016-01-01
A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product). A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive characterization and testing. Special expertise and procedures are needed for their manufacture, control, and regulation. The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all human medical products, including vaccines for human use.The Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for overseeing the regulation of therapeutic and preventative vaccines against infectious diseases. Authority for the regulation of vaccines resides in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C). Vaccines are regulated as biologics and licensed based on the demonstration of safety and effectiveness. The vaccine development process can be divided into two major categories: those events that are not under the regulatory authority of the FDA and are exploratory in nature and those events that are subject to regulatory authority by the FDA. Exploratory events or research and development cover basic research drug discovery processes that occur before the sponsor submits an investigational new drug application (IND) to the FDA. There are four main stages of vaccine development under the purview of regulatory authorities: preclinical, clinical (IND), licensing, and post-licensure. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and NRAs. In this chapter an overview of the regulatory evaluation and testing requirements for vaccines is presented.
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Batey, D Scott; Whitfield, Samantha; Mulla, Mazheruddin; Stringer, Kristi L; Durojaiye, Modupeoluwa; McCormick, Lisa; Turan, Bulent; Nyblade, Laura; Kempf, Mirjam-Colette; Turan, Janet M
2016-11-01
HIV-related stigma has been shown to have profound effects on people living with HIV (PLWH). When stigma is experienced in a healthcare setting, negative health outcomes are exacerbated. We sought to assess the feasibility and acceptability of a healthcare setting stigma-reduction intervention, the Finding Respect and Ending Stigma around HIV (FRESH) Workshop, in the United States. This intervention, adapted from a similar strategy implemented in Africa, brought together healthcare workers (HW) and PLWH to address HIV-related stigma. Two pilot workshops were conducted in Alabama and included 17 HW and 19 PLWH. Participants completed questionnaire measures pre- and post-workshop, including open-ended feedback items. Analytical methods included assessment of measures reliability, pre-post-test comparisons using paired t-tests, and qualitative content analysis. Overall satisfaction with the workshop experience was high, with 87% PLWH and 89% HW rating the workshop "excellent" and the majority agreeing that others like themselves would be interested in participating. Content analysis of open-ended items revealed that participants considered the workshop informative, interactive, well-organized, understandable, fun, and inclusive, while addressing real and prevalent issues. Most pre- and post-test measures had good-excellent internal consistency reliability (Cronbach's alphas ranging from 0.70 to 0.96) and, although sample sizes were small, positive trends were observed, reaching statistical significance for increased awareness of stigma in the health facility among HW (p = 0.047) and decreased uncertainty about HIV treatment among PLWH (p = 0.017). The FRESH intervention appears to be feasible and highly acceptable to HW and PLWH participants and shows great promise as a healthcare setting stigma-reduction intervention for US contexts.
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Whitfield, Samantha; Mulla, Mazheruddin; Stringer, Kristi L.; Durojaiye, Modupeoluwa; McCormick, Lisa; Turan, Bulent; Nyblade, Laura; Kempf, Mirjam-Colette; Turan, Janet M.
2016-01-01
Abstract HIV-related stigma has been shown to have profound effects on people living with HIV (PLWH). When stigma is experienced in a healthcare setting, negative health outcomes are exacerbated. We sought to assess the feasibility and acceptability of a healthcare setting stigma-reduction intervention, the Finding Respect and Ending Stigma around HIV (FRESH) Workshop, in the United States. This intervention, adapted from a similar strategy implemented in Africa, brought together healthcare workers (HW) and PLWH to address HIV-related stigma. Two pilot workshops were conducted in Alabama and included 17 HW and 19 PLWH. Participants completed questionnaire measures pre- and post-workshop, including open-ended feedback items. Analytical methods included assessment of measures reliability, pre–post-test comparisons using paired t-tests, and qualitative content analysis. Overall satisfaction with the workshop experience was high, with 87% PLWH and 89% HW rating the workshop “excellent” and the majority agreeing that others like themselves would be interested in participating. Content analysis of open-ended items revealed that participants considered the workshop informative, interactive, well-organized, understandable, fun, and inclusive, while addressing real and prevalent issues. Most pre- and post-test measures had good–excellent internal consistency reliability (Cronbach's alphas ranging from 0.70 to 0.96) and, although sample sizes were small, positive trends were observed, reaching statistical significance for increased awareness of stigma in the health facility among HW (p = 0.047) and decreased uncertainty about HIV treatment among PLWH (p = 0.017). The FRESH intervention appears to be feasible and highly acceptable to HW and PLWH participants and shows great promise as a healthcare setting stigma-reduction intervention for US contexts. PMID:27849373
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Hemingway, Steve; Stephenson, John; Trotter, Fiona; Clifton, Andrew; Holdich, Phillip
2015-01-01
This paper presents the pre- and post-test results of the outcomes of a workshop designed to increase learning disability and mental health nurses' knowledge and skill to undertake interventions for service users at risk of, or with a diagnosis of, type 2 diabetes. Health literacy is also discussed as a way of explaining why such nurses may lack expertise in physical health care. Findings from the workshop show that learning disability and mental health nurses have the motivation to increase their health literacy (skills and knowledge) in diabetes care. The potential of such workshops, and how organisations looking forward to the future can build health literacy, is discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.
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Zhao, Chengquan
2015-01-01
Screening for cervical cancer with cytology testing has been very effective in reducing cervical cancer in the United States. For decades, the approach was an annual Pap test. In 2000, the Hybrid Capture 2 human papillomavirus (HPV) test was approved by the U.S. Food and Drug Administration (FDA) for screening women who have atypical squamous cells of underdetermined significance (ASCUS) detected by Pap test to determine the need for colposcopy. In 2003, the FDA approved expanding the use of the test to include screening performed in conjunction with a Pap test for women over the age of 30 years, referred to as “cotesting.” Cotesting allows women to extend the testing interval to 3 years if both tests have negative results. In April of 2014, the FDA approved the use of an HPV test (the cobas HPV test) for primary cervical cancer screening for women over the age of 25 years, without the need for a concomitant Pap test. The approval recommended either colposcopy or a Pap test for patients with specific high-risk HPV types detected by the HPV test. This was based on the results of the ATHENA trial, which included more than 40,000 women. Reaction to this decision has been mixed. Supporters point to the fact that the primary-screening algorithm found more disease (cervical intraepithelial neoplasia 3 or worse [CIN3+]) and also found it earlier than did cytology or cotesting. Moreover, the positive predictive value and positive-likelihood ratio of the primary-screening algorithm were higher than those of cytology. Opponents of the decision prefer cotesting, as this approach detects more disease than the HPV test alone. In addition, the performance of this new algorithm has not been assessed in routine clinical use. Professional organizations will need to develop guidelines that incorporate this testing algorithm. In this Point-Counterpoint, Dr. Stoler explains why he favors the primary-screening algorithm, while Drs. Austin and Zhao explain why they prefer the cotesting approach to screening for cervical cancer. PMID:25948606
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Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E
Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001). Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.
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Teacher Professional Development in Laredo, TX
NASA Astrophysics Data System (ADS)
Finkelstein, Keely D.; Macri, L. M.; Hemenway, M.; Wetzel, M.; Preston, S.; Rood, M.
2014-01-01
In the fall of 2012, McDonald Observatory, Texas A&M University, and Texas A&M International University conducted a series of workshops on astronomy content for 5th - 8th grade teachers in Laredo, Texas. Three one-day workshops were held at the Lamar Bruni Vergara Planetarium of Texas A&M International University, using a mix of in-person and distance learning technology. Texas A&M professor Lucas Macri gave public talks in English and Spanish, and a lunch-time presentation to the teachers. A series of evaluation tools were used to assess the success of the workshops. A Nominal Group Technique (NGT) discussion was used, through which groups developed consensus answers about their learning, expectations for classroom use, and satisfaction with the workshop. The Astronomy/Space Science Test (MOSART Grades 5-8) was also issued as a pre- and post-test to assess gains in knowledge. Teacher consensus was that the materials and activities of the workshop had been helpful for learning and that they expected to use many of them in their classrooms. However, the evaluation also showed that teachers would have preferred the Observatory educator be physically present for all workshops. Past video-conferencing workshops, where local facilitators first participated in workshops at the Observatory, showed better feedback and results concerning this point. Comparing those results to the present case, we conclude that more clearly defined roles and better training for the science specialists and local facilitators would improve the video conference experience for the teachers. Comparison of pre- and post-test results showed improved teacher knowledge. An additional benefit of this project was the further development of partnerships between McDonald Observatory and Texas A&M International University, which has resulted in further education projects, including a video-conference presentation series to eight-grade students and their families. This secondary project focused on motivating and increasing underserved students from the Laredo area in STEM fields, and featured lectures from University of Texas / McDonald Observatory astronomers.
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Lynch, Anthony M; Guzzie, Peggy J; Bauer, Daniel; Gocke, Elmar; Itoh, Satoru; Jacobs, Abby; Krul, Cyrille A M; Schepky, Andreas; Tanaka, Noriho; Kasper, Peter
2011-08-16
A workshop to reappraise the previous IWGT recommendations for photogenotoxicity testing [E. Gocke, L. Muller, P.J. Guzzie, S. Brendler-Schwaab, S. Bulera, C.F. Chignell, L.M. Henderson, A. Jacobs, H. Murli, R.D. Snyder, N. Tanaka, Considerations on photochemical genotoxicity: report of the International Workshop on Genotoxicity Test Procedures working group, Environ. Mol. Mutagen., 35 (2000) 173-184] was recently held as part of the 5th International Workshop on Genotoxicity Testing (IWGT) meeting in Basel, Switzerland (August 17-19, 2009). An Expert Panel was convened from regulatory, academic and industrial scientists (with several members serving on the original panel) and chaired by Dr Peter Kasper (BfArM, Germany). The aim of the workshop was to review progress made in photo(geno)toxicity testing over the past decade; a period which saw the introduction of several regulatory photosafety guidances in particular in Europe and the USA. Based on current regulatory guidelines a substantial proportion of compounds trigger the requirements for photosafety testing. Moreover, there has been growing concern within industry about the performance of the in vitro photosafety tests in the "real world" of compound development. Therefore, the expert group reviewed the status of the current regulatory guidance's and the impact these have had on compound development in the context of the various triggers for photosafety testing. In addition, the performance of photogenotoxicity assays (old and new) was discussed, particularly in view of reports of pseudophotoclastogencity. The Expert Panel finished with an assessment of the positioning of photogenotoxicity testing within a photosafety testing strategy. The most significant conclusion made by the Expert Panel was that photogenotoxicity testing should no longer be recommended as part of the standard photosafety testing strategy. In addition, progress was made on the refinement of triggers for photosafety testing. For example, there was support for harmonisation of methods to determine the Molar Extinction Coefficient (MEC) and a consensus agreement that there should be no requirement for testing of compounds with a MEC<1000Lmol(-1)cm(-1). Copyright © 2011 Elsevier B.V. All rights reserved.
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The future of direct-to-consumer clinical genetic tests.
Frueh, Felix W; Greely, Henry T; Green, Robert C; Hogarth, Stuart; Siegel, Sue
2011-06-01
In light of the meeting of the US Food and Drug Administration (FDA) in March 2011 to discuss the regulation of clinical direct-to-consumer (DTC) genetic tests, we have invited five experts to consider the best means of overseeing the ordering and interpretation of these tests. Should these tests be regulated? If so, who, if anyone, should communicate results to consumers?
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77 FR 72924 - Taxable Medical Devices
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-07
... as devices by the FDA Center for Biologics Evaluation and Research (CBER). In general, CBER licenses... designed to implant a particular orthopedic joint; (iv) testing and development products; and (v) product...
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NASA Technical Reports Server (NTRS)
Mcquillen, John; Brown, Dan; Hussey, Sam; Zoldak, John
2014-01-01
The Intravenous Fluid Generation (IVGEN) Experiment was a technology demonstration experiment that purified ISS potable water, mixed it with salt, and transferred it through a sterilizing filter. On-orbit performance was verified as appropriate and two 1.5 l bags of normal saline solution were returned to earth for post-flight testing by a FDA certified laboratory for compliance with United States Pharmacopiea (USP) standards. Salt concentration deviated from required values and an analysis identified probable causes. Current efforts are focused on Total Organic Content (TOC) testing, and shelf life.The Intravenous Fluid Generation (IVGEN) Experiment demonstrated the purification of ISS potable water, the mixing of the purified water with sodium chloride, and sterilization of the solution via membrane filtration. On-orbit performance was monitored where feasible and two 1.5-liter bags of normal saline solution were returned to earth for post-flight testing by a FDA-registered laboratory for compliance with United States Pharmacopeia (USP)standards [1]. Current efforts have been focused on challenge testing with identified [2] impurities (total organic-carbon), and shelf life testing. The challenge testing flowed known concentrations of contaminants through the IVGEN deionizing cartridge and membrane filters to test their effectiveness. One finding was that the filters and DI-resin themselves contribute to the contaminant load during initial startup, suggesting that the first 100 ml of fluid be discarded. Shelf life testing is ongoing and involves periodic testing of stored DI cartridges and membrane filters that are capped and sealed in hermetic packages. The testing is conducted at six month intervals measuring conductivity and endotoxins in the effluent. Currently, the packaging technique has been successfully demonstrated for one year of storage testing. The USP standards specifies that the TOC be conducted at point of generation as opposed to point of consumption. Samples were generated and shipped to an FDA facility however, testing determined that the samples failed the TOC specification with most likely due to leaching from the sample container. Shelf life testing is examining packaging techniques and periodic testing of samples of DI cartridges that are capped and sealed in hermetic packages. Periodic testing of the purified water output will be conducted at six month intervals.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0344...; Testing Communications on Medical Devices and Radiation-Emitting Products AGENCY: Food and Drug... collection of information entitled ``Testing Communications on Medical Devices and Radiation-Emitting...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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... and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical ... æ¥æ¬èª | ÙØ§Ø±Ø³Û | English FDA Accessibility Careers FDA Basics FOIA No FEAR Act ...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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78 FR 18233 - Medical Devices; Technical Amendment
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
... the right column: Section Remove Add 814.20 http://www.fda.gov/ http://www.fda.gov/ cdrh/devadvice.../ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/ AboutFDA/ dispute.html. CentersOffices/ OfficeofMedicalPr oductsandTobacco/ CDRH/ CDRHOmbudsman/ default.htm. 822.15...
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Photovoltaic performance and reliability workshop
DOE Office of Scientific and Technical Information (OSTI.GOV)
Kroposki, B
1996-10-01
This proceedings is the compilation of papers presented at the ninth PV Performance and Reliability Workshop held at the Sheraton Denver West Hotel on September 4--6, 1996. This years workshop included presentations from 25 speakers and had over 100 attendees. All of the presentations that were given are included in this proceedings. Topics of the papers included: defining service lifetime and developing models for PV module lifetime; examining and determining failure and degradation mechanisms in PV modules; combining IEEE/IEC/UL testing procedures; AC module performance and reliability testing; inverter reliability/qualification testing; standardization of utility interconnect requirements for PV systems; need activitiesmore » to separate variables by testing individual components of PV systems (e.g. cells, modules, batteries, inverters,charge controllers) for individual reliability and then test them in actual system configurations; more results reported from field experience on modules, inverters, batteries, and charge controllers from field deployed PV systems; and system certification and standardized testing for stand-alone and grid-tied systems.« less
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DOT National Transportation Integrated Search
2014-12-11
The Oklahoma Department of Transportations (ODOT) herbicide applicator training program consists of initial pesticide applicator training schools followed by independent Certification testing and then on-going yearly continuing education workshops...
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DOT National Transportation Integrated Search
2014-03-31
The Oklahoma Department of Transportations (ODOT) herbicide applicator training program consists of initial pesticide applicator training schools followed by independent Certification testing and then on-going yearly continuing education workshops...
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Proceedings : Direct Fixation Fastener Workshop
DOT National Transportation Integrated Search
1985-06-01
This report is a collection of papers and discussion transcripts from a workshop on direct fixation fastener systems (DFFS) that are increasingly being used in the construction of modern rail transit systems and system extensions. Preservice testing,...
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ERIC Educational Resources Information Center
Walker, Bonnie L.
This report describes Phase II of a project which developed a system for delivering fire safety training to board and care providers who serve adults with developmental disabilities. Phase II focused on developing and pilot testing a "train the trainers" workshop for instructors and field testing the provider's workshop. Evaluation of…
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NASA Technical Reports Server (NTRS)
1974-01-01
The technical aspects of the Skylab-Orbital Workshop are discussed. Original concepts, goals, design philosophy, hardware, and testing are reported. The final flight configuration, overall test program, and mission performance are analyzed. The systems which are examined are: (1) the structural system, (2) the meteoroid shield systems, and (3) the environmental/thermal control subsystem.
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Phillips, Richard D; Bahadori, Tina; Barry, Brenda E; Bus, James S; Gant, Timothy W; Mostowy, Janet M; Smith, Claudia; Willuhn, Marc; Zimmer, Ulrike
2009-09-01
The International Council of Chemical Associations' Long-Range Research Initiative (ICCA-LRI) sponsored a workshop, titled Twenty-First Century Approaches to Toxicity Testing, Biomonitoring, and Risk Assessment, on 16 and 17 June 2008 in Amsterdam, The Netherlands. The workshop focused on interpretation of data from the new technologies for toxicity testing and biomonitoring, and on understanding the relevance of the new data for assessment of human health risks. Workshop participants articulated their concerns that scientific approaches for interpreting and understanding the emerging data in a biologically relevant context lag behind the rapid advancements in the new technologies. Research will be needed to mitigate these lags and to develop approaches for communicating the information, even in a context of uncertainty. A collaborative, coordinated, and sustained research effort is necessary to modernize risk assessment and to significantly reduce current reliance on animal testing. In essence, this workshop was a call to action to bring together the intellectual and financial resources necessary to harness the potential of these new technologies towards improved public health decision making. Without investment in the science of interpretation, it will be difficult to realize the potential that the advanced technologies offer to modernize toxicity testing, exposure science, and risk assessment.
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NASA Astrophysics Data System (ADS)
Kristinayanti, W. S.; Mas Pertiwi, I. G. A. I.; Evin Yudhi, S.; Lokantara, W. D.
2018-01-01
Assessment is an important element in education that shall oversees students’ competence not only in terms of cognitive aspect, but alsothe students’ psychomotorin a comprehensive way. Civil Engineering Department at Bali State Polytechnic,as a vocational education institution, emphasizes on not only the theoretical foundation of the study, but also the application throughpracticum in workshop-based learning. We are aware of a need for performance-based assessment for these students, which would be essential for the student’s all-round performance in their studies.We try to develop a performance-based practicum assessment model that is needed to assess student’s ability in workshop-based learning. This research was conducted in three stages, 1) learning needs analysis, 2) instruments development, and 3) testing of instruments. The study uses rubrics set-up to test students’ competence in the workshop and test the validity. We obtained 34-point valid statement out of 35, and resulted in value of Cronbach’s alpha equal to 0.977. In expert test we obtained a value of CVI = 0.75 which means that the drafted assessment is empirically valid within thetrial group.
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Ready to learn physics: a team-based learning model for first year university
NASA Astrophysics Data System (ADS)
Parappilly, Maria; Schmidt, Lisa; De Ritter, Samantha
2015-09-01
Team-based learning (TBL) is an established model of group work which aims to improve students' ability to apply discipline-related content. TBL consists of a readiness assurance process (RAP), student groups and application activities. While TBL has not been implemented widely in science, technology, engineering and mathematics disciplines, it has been effective in improving student learning in other disciplines. This paper describes the incorporation of TBL activities into a non-calculus based introductory level physics topic—Physics for the Modern World. Students were given pre-class preparation materials and an individual RAP online test before the workshops. The pre-workshop individual RAP test ensured that all students were exposed to concept-based questions before their workshops and motivated them to use the preparatory materials in readiness for the workshop. The students were placed into random teams and during the first part of the workshop, the teams went through a subset of the quiz questions (team RAP test) and in the remaining time, teams completed an in-class assignment. After the workshop students were allowed another attempt at the individual RAP test to see if their knowledge had improved. The ability of TBL to promote student learning of key concepts was evaluated by experiment using pre- and post- testing. The students’ perception of TBL was monitored by discussion posts and survey responses. Finally, the ability of TBL to support peer-peer interaction was evaluated by video analysis of the class. We found that the TBL process improved student learning; students did interact with each other in class; and the students had a positive view of TBL. To assess the transferability of this model to other topics, we conducted a comparison study with an environmental science topic which produced similar results. Our study supports the use of this TBL model in science topics.
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21 CFR 1.280 - How must you submit prior notice?
Code of Federal Regulations, 2010 CFR
2010-04-01
... to FDA. You must submit all prior notice information in the English language, except that an... Commercial System (ABI/ACS); or (2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through the FDA Prior Notice System Interface (FDA PNSI) for articles of food imported or offered for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-13
... of Sunlamps and Sunlamp Products'' FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2012 CFR
2012-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2013 CFR
2013-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2010 CFR
2010-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2011 CFR
2011-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2014 CFR
2014-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...
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21 CFR 830.100 - FDA accreditation of an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... issuing agency. (b) Accreditation criteria. FDA may accredit an organization as an issuing agency, if the...
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Teaching Palatoplasty Using a High-Fidelity Cleft Palate Simulator.
Cheng, Homan; Podolsky, Dale J; Fisher, David M; Wong, Karen W; Lorenz, H Peter; Khosla, Rohit K; Drake, James M; Forrest, Christopher R
2018-01-01
Cleft palate repair is a challenging procedure for cleft surgeons to teach. A novel high-fidelity cleft palate simulator has been described for surgeon training. This study evaluates the simulator's effect on surgeon procedural confidence and palatoplasty knowledge among learners. Plastic surgery trainees attended a palatoplasty workshop consisting of a didactic session on cleft palate anatomy and repair followed by a simulation session. Participants completed a procedural confidence questionnaire and palatoplasty knowledge test immediately before and after the workshop. All participants reported significantly higher procedural confidence following the workshop (p < 0.05). Those with cleft palate surgery experience had higher procedural confidence before (p < 0.001) and after (p < 0.001) the session. Palatoplasty knowledge test scores increased in 90 percent of participants. The mean baseline test score was 28 ± 10.89 percent and 43 ± 18.86 percent following the workshop. Those with prior cleft palate experience did not have higher mean baseline test scores than those with no experience (30 percent versus 28 percent; p > 0.05), but did have significantly higher scores after the workshop (61 percent versus 35 percent; p < 0.05). All trainees strongly agreed or agreed that the simulator should be integrated into training and they would use it again. This study demonstrates the effective use of a novel cleft palate simulator as a training tool to teach palatoplasty. Improved procedural confidence and knowledge were observed after a single session, with benefits seen among trainees both with and without previous cleft experience.
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Cadmium (Tank) Electroplating Alternative
2011-08-01
ASTM F519 HE: 75% NFS 200 hrs HRE : 45% NFS 150 hrs Threshold limit greater than /equal to LHE Cd (AMS 2417G) ASETS Defense Focused Workshop (2011...Test Specimens Reporting Sustained/Threshold load (%NFS), Time to failure. HRE Testing Cd Zn-Ni IVD Al LHE Cd Re-Embrittlement Test Fluids: DI...Hydrogen Embrittlement/ HRE ASTM F519 A5, Type 1.a.1 Brush Plating ASETS Defense Focused Workshop (2011) Luzmarie G. Santiago Materials Engineer Naval Air
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2011-01-01
Marketing pressures, regulatory policies, clinical guidelines, and consumer demand all affect health care providers' knowledge and use of health-related genetic tests that are sold and/or advertised to consumers. In addition, clinical guidelines, regulatory policies, and educational efforts are needed to promote the informed use of genetic tests that are sold and advertised to consumers and health care providers. A shift in culture regarding the regulation of genetic tests that are sold directly to consumers is suggested: by recent actions taken by the US Food and Drug Administration (FDA), including letters sent to direct-to-consumer (DTC) genetic testing companies stating that their tests meet the definition of medical devices; by public meetings held by the FDA to discuss laboratory developed tests; and by the convening of the Molecular and Clinical Genetics Panel to gather input on scientific issues concerning DTC genetic tests that make medical claims. This review provides a brief overview of DTC advertising and the regulation of pharmaceuticals and genetic tests in the United States. It highlights recent changes in the regulatory culture regarding genetic tests that are sold to consumers, and discusses the impact on health care providers of selling and advertising genetic tests directly to consumers. PMID:22204616
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Myers, Melanie F
2011-12-28
Marketing pressures, regulatory policies, clinical guidelines, and consumer demand all affect health care providers' knowledge and use of health-related genetic tests that are sold and/or advertised to consumers. In addition, clinical guidelines, regulatory policies, and educational efforts are needed to promote the informed use of genetic tests that are sold and advertised to consumers and health care providers. A shift in culture regarding the regulation of genetic tests that are sold directly to consumers is suggested: by recent actions taken by the US Food and Drug Administration (FDA), including letters sent to direct-to-consumer (DTC) genetic testing companies stating that their tests meet the definition of medical devices; by public meetings held by the FDA to discuss laboratory developed tests; and by the convening of the Molecular and Clinical Genetics Panel to gather input on scientific issues concerning DTC genetic tests that make medical claims. This review provides a brief overview of DTC advertising and the regulation of pharmaceuticals and genetic tests in the United States. It highlights recent changes in the regulatory culture regarding genetic tests that are sold to consumers, and discusses the impact on health care providers of selling and advertising genetic tests directly to consumers.
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76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... draft guidance does not apply to egg producers and other persons who are covered by FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The... eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence...
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Access to Experimental Cancer Drugs
An experimental drug has been tested in the lab and with animals and approved for testing in people by the FDA, but can’t yet be advertised, sold, or prescribed. Experimental drugs may be available through clinical trials or expanded access programs - learn more about these programs and how to talk to your doctor.
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Multiple Sclerosis: Hope through Research
... been a valuable tool to test whether an experimental new therapy is effective at reducing exacerbations. top ... that they will require aggressive and perhaps even experimental treatment. The current FDA-approved therapies for MS ...
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ERIC Educational Resources Information Center
Moore, John W., Ed.; Moore, Elizabeth A., Ed.
1977-01-01
Discusses the role of the US Food and Drug Administration (FDA) in protecting the American public from carcinogens. Describes scientific testing methodology, risk-benefit analysis and the Delaney clause with its application to saccharin. (CP)
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Workshop on in-vehicle alcohol test devices
DOT National Transportation Integrated Search
1986-09-01
On September 17, 1986, a one-day workshop, sponsored by the National Highway Traffic Safety Administration was held at the Department of Transportation in Washington D.C. The purpose was to bring interested persons together, including manufacturers, ...
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NASA Technical Reports Server (NTRS)
1972-01-01
The proceedings of the 1972 NASA/Goddard Battery Workshop are reported. Topics discussed include: separators, materials and processing, test and storage experience, and improved energy density systems.
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Fifteenth workshop on geothermal reservoir engineering: Proceedings
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1990-01-01
The Fifteenth Workshop on Geothermal Reservoir Engineering was held at Stanford University on January 23--25, 1990. Major topics included: DOE's geothermal research and development program, well testing, field studies, geosciences, geysers, reinjection, tracers, geochemistry, and modeling.
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Second workshop on in-vehicle alcohol test devices
DOT National Transportation Integrated Search
1988-04-01
On October 14, 1987, a one-day workshop sponsored by the National Highway Traffic Safety Administration (NHTSA) was held at the Department of Transportation in Washington, PC. The purpose was to bring interested persons together, including manufactur...
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A drug's life: the pathway to drug approval.
Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A
2013-10-01
In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0253] Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct... Drug Administration's (FDA's) regulations for the protection of privacy, FDA is publishing notice of a...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 830.220 - Termination of FDA service as an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.220 Termination of FDA service as an issuing agency. (a) FDA may end our services as an issuing agency if we...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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Regulatory aspects of noninvasive glucose measurements.
Gutman, Steve; Bernhardt, Patricia; Pinkos, Arleen; Moxey-Mims, Marva; Knott, Thomas; Cooper, Jean
2002-01-01
The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.
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Blood component recalls in the United States.
Ramsey, G; Sherman, L A
1999-05-01
United States blood suppliers are required to recall marketed blood components later found to be in violation of Food and Drug Administration (FDA) regulations for safety, purity, and potency. Many recalled units have already been transfused. Analysis of the frequency and nature of blood component recalls would be useful for blood suppliers, transfusion services, and physicians. Each blood component recall in the weekly FDA Enforcement Report from 1990 through 1997 was examined for the number of units, recall reason, and hazard class. Units for manufacturing were excluded. In 8 years, an estimated 241,800 blood components were recalled, or approximately 1 in 700 units available to US hospitals. Eighty-eight percent of recalled units were in 22 large recalls of over 1000 units each. The most common reasons were incorrect testing for syphilis (57% of units) or viral markers (19%), reactive or previously reactive donor viral markers (6-11%), and inadequate donor-history screening (4%). Twelve units were in the FDA's highest hazard Class I, 24 percent were in Class II, and 76 percent were in Class III. Over 43,900 units had HIV-related problems, but only 3 units involved HIV transmission. Large recalls have declined since peaking in 1995, but units in small recalls increased 116 percent in 1997 over the previous 7-year average. Although high-risk recalls are rare, many blood component recalls pose medical concerns for physicians and patients. The recent decline in large recalls may be due to increased FDA oversight, stricter accreditation standards for quality improvement, and more centralized donor testing in large specialized laboratories. However, smaller recalls, which involve nearly all blood suppliers, were sharply higher in 1997.
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USM3D Simulations for Second Sonic Boom Workshop
NASA Technical Reports Server (NTRS)
Elmiligui, Alaa; Carter, Melissa B.; Nayani, Sudheer N.; Cliff, Susan; Pearl, Jason M.
2017-01-01
The NASA Tetrahedral Unstructured Software System with the USM3D flow solver was used to compute test cases for the Second AIAA Sonic Boom Prediction Workshop. The intent of this report is to document the USM3D results for SBPW2 test cases. The test cases included an axisymmetric equivalent area body, a JAXA wing body, a NASA low boom supersonic configuration modeled with flow through nacelles and engine boundary conditions. All simulations were conducted for a free stream Mach number of 1.6, zero degrees angle of attack, and a Reynolds number of 5.7 million per meter. Simulations were conducted on tetrahedral grids provided by the workshop committee, as well as a family of grids generated by an in-house approach for sonic boom analyses known as BoomGrid using current best practices. The near-field pressure signatures were extracted and propagated to the ground with the atmospheric propagation code, sBOOM. The USM3D near-field pressure signatures, corresponding sBOOM ground signatures, and loudness levels on the ground are compared with mean values from other workshop participants.
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Statistical Analysis of CFD Solutions from the Third AIAA Drag Prediction Workshop
NASA Technical Reports Server (NTRS)
Morrison, Joseph H.; Hemsch, Michael J.
2007-01-01
The first AIAA Drag Prediction Workshop, held in June 2001, evaluated the results from an extensive N-version test of a collection of Reynolds-Averaged Navier-Stokes CFD codes. The code-to-code scatter was more than an order of magnitude larger than desired for design and experimental validation of cruise conditions for a subsonic transport configuration. The second AIAA Drag Prediction Workshop, held in June 2003, emphasized the determination of installed pylon-nacelle drag increments and grid refinement studies. The code-to-code scatter was significantly reduced compared to the first DPW, but still larger than desired. However, grid refinement studies showed no significant improvement in code-to-code scatter with increasing grid refinement. The third Drag Prediction Workshop focused on the determination of installed side-of-body fairing drag increments and grid refinement studies for clean attached flow on wing alone configurations and for separated flow on the DLR-F6 subsonic transport model. This work evaluated the effect of grid refinement on the code-to-code scatter for the clean attached flow test cases and the separated flow test cases.
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NASA Technical Reports Server (NTRS)
Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.
2007-01-01
Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.
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The future of direct-to-consumer clinical genetic tests
Frueh, Felix W.; Greely, Henry T.; Green, Robert C.; Hogarth, Stuart; Siegel, Sue
2013-01-01
In light of the meeting of the US Food and Drug Administration (FDA) in March 2011 to discuss the regulation of clinical direct-to-consumer (DTC) genetic tests, we have invited five experts to consider the best means of overseeing the ordering and interpretation of these tests. Should these tests be regulated? If so, who, if anyone, should communicate results to consumers? PMID:21629275
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FDA Warns About Stem Cell Therapies
... For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...
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Nuclear Innovation Workshops Report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Jackson, John Howard; Allen, Todd Randall; Hildebrandt, Philip Clay
The Nuclear Innovation Workshops were held at six locations across the United States on March 3-5, 2015. The data collected during these workshops has been analyzed and sorted to bring out consistent themes toward enhancing innovation in nuclear energy. These themes include development of a test bed and demonstration platform, improved regulatory processes, improved communications, and increased public-private partnerships. This report contains a discussion of the workshops and resulting themes. Actionable steps are suggested at the end of the report. This revision has a small amount of the data in Appendix C removed in order to avoid potential confusion.
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... FDA – This Free Life Campaign HIV.gov on Twitter 1 day 26 min ago. HIV.gov @HIVGov # ... routine. #HIVTestingDay Reply Retweet Favorite HIV.gov on Twitter Search Find HIV Testing Sites & Care Services Connect ...
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Didwania, Aashish; Farnan, Jeanne M; Icayan, Liza; O'Leary, Kevin J; Saathoff, Mark; Bellam, Shashi; Humphrey, Holly J; Wayne, Diane B; Arora, Vineet M
2017-04-01
Unprofessional behaviors undermine the hospital learning environment and the quality of patient care. To assess the impact of an interactive workshop on the perceptions of and self-reported participation in unprofessional behaviors. We conducted a pre-post survey study at 3 internal medicine residency programs. For the workshop we identified unprofessional behaviors related to on-call etiquette: "blocking" an admission, disparaging a colleague, and misrepresenting a test as urgent. Formal debriefing tools were utilized to guide the discussion. We fielded an internally developed 20-item survey on perception and participation in unprofessional behaviors prior to the workshop. An online "booster" quiz was delivered at 4 months postworkshop, and the 20-item survey was repeated at 9 months postworkshop. Results were compared to a previously published control from the same institutions, which showed that perceptions of unprofessional behavior did not change and participation in the behaviors worsened over the internship. Of 237 eligible residents, 181 (76%) completed both pre- and postsurvey. Residents perceived blocking an admission and the misrepresentation of a test as urgent to be more unprofessional at a 9-month follow-up (2.0 versus 1.74 and 2.63 versus 2.28, respectively; P < .05), with no change in perception for disparaging a colleague. Participation in unprofessional behaviors did not decrease after the workshop, with the exception of misrepresenting a test as urgent (61% versus 50%, P = .019). The results of this multi-site study indicate that an interactive workshop can change perception and may lower participation in some unprofessional behaviors.
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Preoperative preparation workshop reduces postoperative maladaptive behavior in children.
Hilly, Julie; Hörlin, Anne-Laure; Kinderf, Joelle; Ghez, Cecile; Menrath, Sabrina; Delivet, Honorine; Brasher, Christopher; Nivoche, Yves; Dahmani, Souhayl
2015-10-01
Postoperative maladaptive behaviors (POMBs) are common following pediatric anesthesia, and preoperative anxiety is associated with POMBs. A family-centered preoperative preparation workshop was instituted with the aim of reducing the incidence of POMB and preoperative anxiety, and the study was constructed to evaluate its effectiveness. A prospective cohort study was constructed, comparing patients who attended the workshop (workshop group) with patients who did not attend and who were matched for age and type of surgery (comparison group). Preoperative anxiety was measured using the mYPAS score, postoperative emergence agitation (EA) was measured using the PAED score, POMBs were assessed with the Post-Hospital Behavior Questionnaire (PHBQ) on postoperative day 7, and PACU morphine consumption and PACU length of stay were recorded. Statistical analysis was performed employing the X² test, the Fisher's exact test, and the Mann-Whitney test as appropriate. Data were expressed as median [minimum, maximum]. Fifty-six patients from 3 to 18 years of age were recruited. Twenty-seven patients in the workshop group were compared to 26 in the comparison group, after exclusions for missing data. Significant differences were demonstrated between groups for POMBs intensity (PHBQ score 2 [0; 9] vs 5 [0; 10], P = 0.008) and incidence (PHBQ score >6: 3.6% vs 35.7%, P = 0.003), and for mYPAS score (28 [23; 87] vs 37 [23;100], P = 0.015). No difference was found for EA, PACU morphine consumption, or PACU length of stay. The workshop appears to result in reduced preoperative anxiety and POMBs. © 2015 John Wiley & Sons Ltd.
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Statistical Analysis of CFD Solutions from the Fourth AIAA Drag Prediction Workshop
NASA Technical Reports Server (NTRS)
Morrison, Joseph H.
2010-01-01
A graphical framework is used for statistical analysis of the results from an extensive N-version test of a collection of Reynolds-averaged Navier-Stokes computational fluid dynamics codes. The solutions were obtained by code developers and users from the U.S., Europe, Asia, and Russia using a variety of grid systems and turbulence models for the June 2009 4th Drag Prediction Workshop sponsored by the AIAA Applied Aerodynamics Technical Committee. The aerodynamic configuration for this workshop was a new subsonic transport model, the Common Research Model, designed using a modern approach for the wing and included a horizontal tail. The fourth workshop focused on the prediction of both absolute and incremental drag levels for wing-body and wing-body-horizontal tail configurations. This work continues the statistical analysis begun in the earlier workshops and compares the results from the grid convergence study of the most recent workshop with earlier workshops using the statistical framework.
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Workshop summary: Space environmental effects
NASA Technical Reports Server (NTRS)
Meulenberg, A.; Anspaugh, B. E.
1991-01-01
The workshop on Space Environmental Effects is summarized. The underlying concern of the group was related to the question of how well laboratory tests correlate with actual experience in space. The discussion ranged over topics pertaining to tests involving radiation, atomic oxygen, high voltage plasmas, contamination in low earth orbit, and new environmental effects that may have to be considered on arrays used for planetary surface power systems.
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Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.
Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J
2016-01-01
Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.
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Bastiaans, Diane E T; Forcat, Silvia; Lyall, Hermione; Cressey, Tim R; Hansudewechakul, Rawiwan; Kanjanavanit, Suparat; Noguera-Julian, Antoni; Königs, Christoph; Inshaw, Jamie R J; Chalermpantmetagul, Suwalai; Saïdi, Yacine; Compagnucci, Alexandra; Harper, Lynda M; Giaquinto, Carlo; Colbers, Angela P H; Burger, David M
2014-03-01
Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval and only body surface area by the EMA. This can lead to a different recommended dose. In addition, weight band-based dosing has not been formally studied in the target population. We evaluated the pharmacokinetics (PK) of LPV/r in children, administered twice daily according to the FDA weight bands, using pediatric tablets. Fifty-three HIV-infected children were included in the PK substudy of the Paediatric European Network for the Treatment of AIDS 18 trial (KONCERT). In this study, children were randomized to receive LPV/r twice or once daily, according to FDA weight bands. A PK assessment was performed in 17, 16 and 20 children in the 15-25 kg, ≥ 25-35 kg and >35 kg weight band, respectively, while children took the tablets twice daily. Rich sampling was performed, and PK parameters were calculated by noncompartmental analysis. Given the high percentage of Asian children, it was also tested whether there was a difference in PK parameters between Asian and non-Asian children. For the total group, LPV geometric mean AUC0-12, Cmax and C12 were 106.9 h × mg/L, 12.0 mg/L and 4.9 mg/L, respectively. There were no significant differences in LPV PK parameters between the weight bands. In addition, weight was not found to be associated with variability in Cmax, C12 or AUC0-12 for the LPV PK parameters. FDA weight band-based dosing recommendations provide adequate exposure to LPV when using LPV/r pediatric tablets.
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West Nile Virus workshop: scientific considerations for tissue donors.
Brubaker, Scott A; Robert Rigney, P
2012-08-01
This report contains selected excerpts, presented as a summary, from a public workshop sponsored by the American Association of Tissue Banks (AATB) held to discuss West Nile Virus (WNV) and scientific considerations for tissue donors. The daylong workshop was held 9 July 2010 at the Ritz-Carlton Hotel at Tyson's Corner in McLean, Virginia, United States (U.S.). The workshop was designed to determine and discuss scientific information that is known, and what is not known, regarding WNV infection and transmission. The goal is to determine how to fill gaps in knowledge of WNV and tissue donation and transplantation by pursuing relevant scientific studies. This information should ultimately support decisions leading to appropriate tissue donor screening and testing considerations. Discussion topics were related to identifying these gaps and determining possible solutions. Workshop participants included subject-matter experts from the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Health Canada, the Public Health Agency of Canada, AATB-accredited tissue banks including reproductive tissue banks, accredited eye banks of the Eye Bank Association of America, testing laboratories, and infectious disease and organ transplantation professionals. After all presentations concluded, a panel addressed this question: "What are the scientific considerations for tissue donors and what research could be performed to address those considerations?" The slide presentations from the workshop are available at: http://www.aatb.org/2010-West-Nile-Virus-Workshop-Presentations.
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1995-07-01
spectabilis Royal fern C FDA n/o Remirea maritima Beach star E FDA, FNAI o Scaevola plumeria Scaevola T FDA o Tillandsia simulata Wildpine; air plant...unnamed) T FDA n/o Tillandsia utriculata Giant wildpine; giant air plant C FDA o 1 E = Endangered; T = Threatened; T(S/A) = Threatened due to
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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Code of Federal Regulations, 2014 CFR
2014-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare Department... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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21 CFR 830.210 - Eligibility for use of FDA as an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Eligibility for use of FDA as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.210 Eligibility for use of FDA as an issuing agency. When FDA acts as an issuing agency, any labeler will be...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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Code of Federal Regulations, 2013 CFR
2013-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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Code of Federal Regulations, 2012 CFR
2012-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2011 CFR
2011-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...