Sample records for public workshop fda
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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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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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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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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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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
2013-06-05
...] 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 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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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
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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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 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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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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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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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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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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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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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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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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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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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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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 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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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
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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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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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 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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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
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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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
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
2013-09-23
... 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
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
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
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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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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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
2013-01-24
... 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
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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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
2010-09-24
... 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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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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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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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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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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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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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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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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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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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
2013-08-14
... 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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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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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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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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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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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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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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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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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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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
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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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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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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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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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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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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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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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
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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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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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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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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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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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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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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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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OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.
Kass-Hout, Taha A; Xu, Zhiheng; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A
2016-05-01
The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Using cutting-edge technologies deployed on FDA's new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved.
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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-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.
Phillips, Adam T; Desai, Nihar R; Krumholz, Harlan M; Zou, Constance X; Miller, Jennifer E; Ross, Joseph S
2017-07-18
Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA. For published trials, we compared the published interpretation of the findings (positive, equivocal, or negative) with the FDA reviewer's interpretation. Between 2005 and 2014, the FDA approved 30 drugs for 32 indications of cardiovascular disease (n = 17) and diabetes (n = 15) on the basis of 183 trials (median per indication 5.7 (IQR, 3-8)). Compared with pre FDAAA, post-FDAAA studies were more likely to be registered (78 of 78 (100%) vs 73 of 105 (70%); p < 0.001), to be published (76 of 78 (97%) vs 93 of 105 (89%); p = 0.03), and to present findings concordant with the FDA reviewer's interpretation (74 of 76 (97%) vs 78 of 93 (84%); p = 0.004). Pre FDAAA, the FDA reviewer interpreted 80 (76%) trials as positive and 91 (98%) were published as positive. Post FDAAA, the FDA reviewer interpreted 71 (91%) trials as positive and 71 (93%) were published as positive. FDAAA was associated with increased registration, publication, and FDA-concordant outcome reporting for trials supporting FDA approval of new drugs for cardiovascular disease and diabetes.
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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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Current FDA directives for promoting public health
DOE Office of Scientific and Technical Information (OSTI.GOV)
Hayes, A.H. Jr.
1982-03-01
The current directions of the FDA are outlined. The underlying philosophy of the FDA under the Reagan Administration is that both the private sector and the government must address the responsibilities to which they are best suited for the health-care system to work more efficiently. To facilitate this, FDA is conducting comprehensive reviews of FDA regulations and the drug-evaluation process. There are many dimensions to promoting public health, and the FDA alone cannot assure an adequate supply of safe and effective drugs. Innovative science and technology are needed to develop new drugs, followed by maximum potentiation (maximum good and leastmore » harm) after FDA approval. Hospital pharmacists have a role in maximizing the potential benefits of drugs through pharmacy and therapeutics committees. The current status of the pilot program for patient package inserts is described. The response at a recent hearing on the program indicates that the responsibility to protect the public health is shared by the government, health professions, industry, and the public. The FDA's campaign on sodium is based on that shared responsibility. By improving communication and building upon their common objections, both pharmacy and the FDA can do their jobs successfully.« less
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21 CFR 5.1110 - FDA public information offices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The...
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21 CFR 5.1110 - FDA public information offices.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The...
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21 CFR 5.1110 - FDA public information offices.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The...
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21 CFR 5.1110 - FDA public information offices.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The...
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21 CFR 5.1110 - FDA public information offices.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The...
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OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data
Kass-Hout, Taha A; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A
2016-01-01
Objective The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Materials and Methods Using cutting-edge technologies deployed on FDA’s new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Results Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. Conclusion With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. PMID:26644398
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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
2011-03-14
... Act: Title III--A New Paradigm for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS... announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title III--A New Paradigm for.... In particular, title III of FSMA significantly enhances FDA's authority for oversight of the millions...
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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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Healthy public relations: the FDA's 1930s legislative campaign.
Kay, G
2001-01-01
In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.
Hemmerich, Natalie; Klein, Elizabeth G; Berman, Micah
2017-08-01
Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation. Copyright © 2017 by Duke University Press.
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Non-Ionizing Radiation Used in Microwave Ovens
... Human Services (HHS), U.S. Food and Drug Administration (FDA) FDA's Center for Devices and Radiological Health (CDRH) sets ... public health. These standards can be viewed on FDA's Code of Federal Regulations on Microwave Ovens . FDA ...
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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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ERIC Educational Resources Information Center
Sinovic, Dianna
Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…
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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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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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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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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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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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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
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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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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-23
...; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1090...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-28
.... FDA-2012-N-1148] FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products... comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain...
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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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Solomon, Louis M; Noll, Rebekka C; Mordkoff, David S; Murphy, Patrick; Rolerson, Marcy
2009-09-01
To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyzes the risks the FDA considered, and concludes that there is a disconnect between the risks the FDA assessed in these studies and the risks that might arise from cloned food products. The FDA should consider instituting effective tracking mechanisms and other diagnostics that would permit scientists and the public to answer the question of health risks posed by cloned food products.
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76 FR 76738 - Generic Drug User Fee; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. The Food and Drug Administration (FDA) is announcing a public meeting to...
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76 FR 19375 - Safety and Efficacy of Hypnotic Drugs; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Safety and Efficacy of Hypnotic Drugs; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a public meeting to...
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21 CFR 516.52 - Availability for public disclosure of data and information in requests.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Availability for public disclosure of data and... Availability for public disclosure of data and information in requests. (a) FDA will not publicly disclose the... acknowledged, no data or information in the request are available for public disclosure prior to final FDA...
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21 CFR 516.52 - Availability for public disclosure of data and information in requests.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Availability for public disclosure of data and... Availability for public disclosure of data and information in requests. (a) FDA will not publicly disclose the... acknowledged, no data or information in the request are available for public disclosure prior to final FDA...
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21 CFR 516.52 - Availability for public disclosure of data and information in requests.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Availability for public disclosure of data and... Availability for public disclosure of data and information in requests. (a) FDA will not publicly disclose the... acknowledged, no data or information in the request are available for public disclosure prior to final FDA...
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21 CFR 516.52 - Availability for public disclosure of data and information in requests.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Availability for public disclosure of data and... Availability for public disclosure of data and information in requests. (a) FDA will not publicly disclose the... acknowledged, no data or information in the request are available for public disclosure prior to final FDA...
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21 CFR 516.52 - Availability for public disclosure of data and information in requests.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Availability for public disclosure of data and... Availability for public disclosure of data and information in requests. (a) FDA will not publicly disclose the... acknowledged, no data or information in the request are available for public disclosure prior to final FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-30
...] FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code Names... replaced non- informative code names with descriptive identifiers on its public database of products that... on our public database with non-informative code names. After careful consideration of this matter...
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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, 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, 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...
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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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75 FR 28051 - Public Workshop: Pieces of Privacy
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-19
... DEPARTMENT OF HOMELAND SECURITY Office of the Secretary Public Workshop: Pieces of Privacy AGENCY: Privacy Office, DHS. ACTION: Notice announcing public workshop. SUMMARY: The Department of Homeland Security Privacy Office will host a public workshop, ``Pieces of Privacy.'' DATES: The workshop will be...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0708] Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal...: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...
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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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Rieves, Dwaine; Jacobs, Paula
2016-12-01
Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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Code of Federal Regulations, 2012 CFR
2012-07-01
... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Pets. 13.978 Section 13.978 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK... (fda) § 13.978 Pets. Possessing a pet is prohibited— (a) In the FDA, except in public parking areas, on...
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Code of Federal Regulations, 2013 CFR
2013-07-01
... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Pets. 13.978 Section 13.978 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK... (fda) § 13.978 Pets. Possessing a pet is prohibited— (a) In the FDA, except in public parking areas, on...
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78 FR 65588 - Medical Gas Regulation Review; Announcement of Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0001] Medical Gas Regulation Review; Announcement of Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a...
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78 FR 43209 - Narcolepsy Public Meeting on Patient-Focused Drug Development
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0815] Narcolepsy Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA...
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78 FR 58313 - Fibromyalgia Public Meeting on Patient-Focused Drug Development
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-1041] Fibromyalgia Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA...
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Real-World Evidence, Public Participation, and the FDA.
Schwartz, Jason L
2017-11-01
For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1040] Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments AGENCY: Food... Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how...
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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
2013-01-25
... currently assessing any additional data requirements. In this regard, FDA published an Advance Notice of... report. Here, e-form FDA 3744a and reporting via the Electronic Submission Gateway are provided by FDA... January 17, 2012 (77 FR 2302), FDA published a 60-day notice requesting public comment on the proposed...
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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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Communicating Tobacco Product Information to the Public.
Berman, Micah L; Byron, M Justin; Hemmerich, Natalie; Lindblom, Eric N; Lazard, Allison J; Peters, Ellen; Brewer, Noel T
2017-01-01
The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) requires tobacco companies to disclose information about the harmful chemicals in their products to the U.S. Food and Drug Administration (FDA). The law requires the FDA, in turn, to communicate this information to the public "in a format that is understandable and not misleading to a lay person." But how should the FDA comply with this requirement? What does it mean for information about complex chemicals to be "understandable and not misleading to a lay person"? These questions are not easy ones to answer. Disclosures about the amount of harmful chemicals (constituents) in different tobacco products may help to inform consumers, but may also conversely prompt consumers to reach incorrect or unsupported conclusions about products' relative health risks. This paper first analyzes the FDA's legal obligation to publish tobacco constituent information so that it is "understandable and not misleading to a layperson." Second, it discusses how that legal analysis has guided scientific research examining how members of the public interpret messages regarding tobacco constituents. Lastly, this paper concludes with policy recommendations for the FDA as it considers how to comply with the law's constituent disclosure requirement while still furthering its overall objective of promoting public health.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-28
... (L2-S1) degenerative disc disease. FDA intends to make background material available to the public no... providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee...
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21 CFR 314.72 - Change in ownership of an application.
Code of Federal Regulations, 2013 CFR
2013-04-01
... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...
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21 CFR 314.72 - Change in ownership of an application.
Code of Federal Regulations, 2011 CFR
2011-04-01
... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...
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21 CFR 314.72 - Change in ownership of an application.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...
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21 CFR 314.72 - Change in ownership of an application.
Code of Federal Regulations, 2012 CFR
2012-04-01
... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...
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Federal Register 2010, 2011, 2012, 2013, 2014
2016-10-04
...] Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments... Semantic Interoperability of Laboratory Data.'' The purpose of this public workshop is to receive and... Semantic Interoperability of Laboratory Data.'' Received comments will be placed in the docket and, except...
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Jenson, Desmond; Lester, Joelle; Berman, Micah L
2016-05-01
Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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2008-11-07
The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."
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77 FR 43601 - Risks and Benefits of Hydroxyethyl Starch Solutions; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-25
...] Risks and Benefits of Hydroxyethyl Starch Solutions; Public Workshop AGENCY: Food and Drug... public workshop entitled: ``Risks and Benefits of Hydroxyethyl Starch Solutions.'' The purpose of this... starch (HES) solutions. The public workshop has been planned in partnership with the Department of...
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76 FR 58281 - Magnetic Resonance Imaging Safety; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-20
... announcing a public workshop entitled: ``Magnetic Resonance Imaging (MRI) Safety Public Workshop.'' The... (MRI) and approaches to mitigate risks. The overall goal is to discuss strategies to minimize patient and staff risk in the MRI environment. DATES: The public workshop will be held on October 25, 2011...
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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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Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn
2014-06-01
This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.
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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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Turning point or tipping point: new FDA draft guidances and the future of DTC advertising.
Pitts, Peter J
2004-01-01
According to Food and Drug Administration (FDA) research, direct-to-consumer (DTC) drug ads are not as empowering as they were even three years ago. How will the FDA's new draft guidances reverse this trend and affect the future of DTC advertising? Will they be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative, or a tipping point with politicians and the public zeroing in on aggressively targeted DTC ads as the postimportation pharmaceutical bête noire? The FDA believes that its new guidances strengthen the strategic argument that a better-informed consumer lays the groundwork for a better potential customer.
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76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...
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77 FR 15719 - Public Workshop to Seek Comment on Federal Conformity Assessment Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-16
... (NIST), Department of Commerce. ACTION: Notice of Public Workshop. SUMMARY: The U.S. Department of Commerce's (DOC) National Institute of Standards and Technology (NIST) will hold a free public workshop.... Eastern Time (ET) at NIST in Gaithersburg, Maryland. The purpose of the NIST public workshop is (1) to...
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ERIC Educational Resources Information Center
Miller, Annetta K.
The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…
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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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Moreno, Santiago G; Sutton, Alex J; Ades, A E; Cooper, Nicola J; Abrams, Keith R
2011-11-01
To extend, apply, and evaluate a regression-based approach to adjusting meta-analysis for publication and related biases. The approach uses related meta-analyses to improve estimation by borrowing strength on the degree of bias. The proposed adjustment approach is described. Adjustments are applied both independently and by borrowing strength across journal-extracted data on the effectiveness of 12 antidepressant drugs from placebo-controlled trials. The methods are also applied to Food and Drug Administration (FDA) data obtained on the same 12 drugs. Results are compared, viewing the FDA observed data as gold standard. Estimates adjusted for publication biases made independently for each drug were very uncertain using both the journal and FDA data. Adjusted estimates were much more precise when borrowing strength across meta-analyses. Reassuringly, adjustments in this way made to the journal data agreed closely with the observed estimates from the FDA data, while the adjusted FDA results changed only minimally from those observed from the FDA data. The method worked well in the case study considered and therefore further evaluation is encouraged. It is suggested that this approach may be especially useful when adjusting several meta-analyses on similar interventions and outcomes, particularly when there are small numbers of studies. Copyright © 2011 Elsevier Inc. All rights reserved.
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Singh, Vijay K; Garcia, Melissa; Seed, Thomas M
2017-09-01
The threat of a radiological/nuclear event is a critical concern for all government agencies involved in national security and public health preparedness. Countermeasures that are safe, easily administered, and effective at diminishing or eliminating adverse health effects to individuals and the overall public health impact of radiation exposure are urgently needed. Radiation countermeasures included in this three-part series have been classified under various subheadings based specifically on their developmental stages for United States Food and Drug Administration (FDA) approval. We have included FDA-approved agents for acute radiation syndrome (ARS) in part I. This is part II in which we have reviewed FDA-approved agents for limited indications, internalized radionuclides, emesis, late effects, radiomitigators available in the strategic national stockpile (SNS), agents with FDA investigational new drug (IND) status, and those with NHP efficacy data without FDA IND. Agents discussed in part III are those agents that have been peer reviewed, published, and have demonstrated significant survival benefits in animal models of ARS. Agents investigated in in vitro models only or studied in animal models without peer-reviewed publications have not been included. The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. A number of promising radiation countermeasures are currently moving forward with continued support and effort by both governmental agencies and by publicly and privately held pharmaceutical companies. There is a limited number of countermeasures which are progressing well following the Animal Rule and may get approved in the near future, thus serving to close the gap of this critically important, unmet radiobiomedical need.
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75 FR 17145 - Food Additives; Bisphenol A; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
... five documents related to FDA's continuing assessment of Bisphenol A (BPA) and soliciting public...). These documents do not represent an agency opinion or position on BPA, on which an interim update was... assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA...
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76 FR 63305 - Approaches To Reducing Sodium Consumption; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-12
... Service (FSIS), the Agricultural Research Service (ARS) and the Center for Nutrition Policy and Promotion... future Agency activities regarding the reduction of dietary intake of sodium. FDA, CDC, FSIS, ARS, and..._Sodium_Reduction by November 3, 2011. FDA, CDC, FSIS, ARS, and CNPP are holding the public meeting on...
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Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M
2017-01-01
Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies’ transparency records and recognise exemplary companies may encourage further progress. PMID:29208616
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77 FR 46096 - Statistical Process Controls for Blood Establishments; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-02
...] Statistical Process Controls for Blood Establishments; Public Workshop AGENCY: Food and Drug Administration... workshop entitled: ``Statistical Process Controls for Blood Establishments.'' The purpose of this public workshop is to discuss the implementation of statistical process controls to validate and monitor...
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75 FR 12768 - Blood Products Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-17
...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, CBER, FDA. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0180] Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food.... SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0536... Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0579... Deviations in Manufacturing; Forms FDA 3486 and 3486A AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0194... Cover Sheet; Form FDA 3792 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0508... Registration and Product Listing, Form FDA 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324..., FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business... Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...
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Working draft of the FDA GMP final rule (Part II).
Donawa, M E
1995-11-01
Part I of this two-part series provided information on the proposed design control provisions of the US Food and Drug Administration's (FDA) working draft of the final rule for new good manufacturing practice regulations for medical devices. The final rule could be published in April or May 1996. It would be in force 180 days after the date of publication. Design control requirements may become effective some months later. This article describes recommended modifications of three provisions that have been intensely discussed during recent FDA-sponsored public meetings.
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78 FR 32010 - Pipeline Safety: Public Workshop on Integrity Verification Process
Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
.... PHMSA-2013-0119] Pipeline Safety: Public Workshop on Integrity Verification Process AGENCY: Pipeline and... announcing a public workshop to be held on the concept of ``Integrity Verification Process.'' The Integrity Verification Process shares similar characteristics with fitness for service processes. At this workshop, the...
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Drugs and Alcohol in Civil Aviation Accident Pilot Fatalities from 2004-2008
2011-09-01
Quinine 16 0.9 19 1.1 37 2.3 42 3.1 FDA Salicylatesβ 96 5.2 114 6.8 41 2.6 11 0.8 FDA Simethicone 0 0.0 0 0.0 0 0.0 1 0.1 FDA 1996... Simethicone 0 0.0 0 0.0 0 0.0 1 0.1 FDA 1996 Triprolidine 0 0.0 0 0.0 2 0.1 2 0.1 FDA β – Screening Cutoff Increased in 2002 μ - Public Law
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NASA Technical Reports Server (NTRS)
Green, Robert O. (Editor)
1998-01-01
This publication contains the summaries for the Seventh JPL Airborne Earth Science Workshop, held in Pasadena, California, on January 12-16, 1998. The main workshop is divided into three smaller workshops, and each workshop has a volume as follows: (1) Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) Workshop; (2) Airborne Synthetic Aperture Radar (AIRSAR) Workshop; and (3) Thermal Infrared Multispectral Scanner (TIMS) Workshop. This Volume 1 publication contains 58 papers taken from the AVIRIS workshop.
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78 FR 58318 - Clinical Trial Design for Intravenous Fat Emulsion Products; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-23
...] Clinical Trial Design for Intravenous Fat Emulsion Products; Public Workshop AGENCY: Food and Drug... announcing a 1-day public workshop entitled ``Clinical Trial Design for Intravenous Fat Emulsion Products.'' This workshop will provide a forum to discuss trial design of clinical trials intended to support...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-31
... Amyotrophic Lateral Sclerosis; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0035...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-19
...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket Nos...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-23
... Administration--Partnering With Industry; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a joint conference with... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...
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78 FR 66747 - Sickle Cell Disease Public Meeting on Patient-Focused Drug Development
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
...] Sickle Cell Disease Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug... Development for sickle cell disease. Patient-Focused Drug Development is part of FDA's performance commitments... intended to allow FDA to obtain patients' perspectives on the impact of sickle cell disease on daily life...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory... Administration (FDA) is requesting nominations for members to serve on the Risk Communication Advisory Committee...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-07
... Microbiological Effects on Bacteria of Human Health Concern'' ( http://www.fda.gov/AnimalVeterinary/Guidance... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1046] Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders; Public Meetings; Request for...
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Public Support for Mandated Nicotine Reduction in Cigarettes
Abrams, David B.; Niaura, Raymond S.; Richardson, Amanda; Vallone, Donna M.
2013-01-01
Objectives. We assessed public support for a potential Food and Drug Administration (FDA)–mandated reduction in cigarette nicotine content. Methods. We used nationally representative data from a June 2010 cross-sectional survey of US adults (n = 2649) to obtain weighted point estimates and correlates of support for mandated nicotine reduction. We also assessed the potential role of political ideology in support of FDA regulation of nicotine. Results. Nearly 50% of the public supported mandated cigarette nicotine reduction, with another 28% having no strong opinion concerning this potential FDA regulation. Support for nicotine reduction was highest among Hispanics, African Americans, and those with less than a high school education. Among smokers, the odds of supporting FDA nicotine regulation were 2.77 times higher among smokers who intended to quit in the next 6 months than among those with no plans to quit. Conclusions. Mandating nicotine reduction in cigarettes to nonaddictive levels may reduce youth initiation and facilitate adult cessation. The reasons behind nicotine regulation need to be communicated to the public to preempt tobacco industry efforts to impede such a regulation. PMID:23327262
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-21
... series of public workshops entitled ``Designing for Impact: Workshop on Building the National Network for...-president-manufacturing-and-economy . The Designing for Impact workshop series is organized by the federal...: ``Designing for Impact III: Workshop on Building the National Network for Manufacturing Innovation'' AGENCY...
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75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381... fee program. The number of human generic drug applications awaiting FDA action and the median review... needed for presentations, FDA reserves the right to terminate the meeting early. If you need special...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA... the treatment of depression. FDA intends to make background material available to the public no later...
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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-0128... participation. SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to request that public... academic experts--notify FDA of their intent to participate in periodic consultation meetings on...
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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-0250... Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain..., [email protected]fda.hhs.gov . SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal...
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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-0748... Cover Sheet; Form FDA 3794 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0015... Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471...; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0653... Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1131... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...
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Turner, Erick H.; Knoepflmacher, Daniel; Shapley, Lee
2012-01-01
Background Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy. Methods and Findings FDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant. Conclusions The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs. Please see later in the article for the Editors' Summary PMID:22448149
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-30
...).'' This workshop series provides a forum for the AMNPO to present the proposed design of the National...: Blueprint for Action: Workshop on the Design of the National Network for Manufacturing Innovation (NNMI... Standards and Technology (NIST), announces the first workshop in a new series of public workshops entitled...
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BLAKE, KELLY D.; PORTNOY, DAVID B.; KAUFMAN, ANNETTE R.; LIN, CHUNG-TUNG JORDAN; LO, SERENA C.; BACKLUND, ERIC; CANTOR, DAVID; HICKS, LLOYD; LIN, AMY; CAPORASO, ANDREW; DAVIS, TERISA; MOSER, RICHARD P.; HESSE, BRADFORD W.
2016-01-01
The National Cancer Institute (NCI) developed the Health Information National Trends Survey (HINTS) to monitor population trends in cancer communication practices, information preferences, health risk behaviors, attitudes, and cancer knowledge. The U.S. Food and Drug Administration (FDA) recognized HINTS as a unique data resource for informing its health communication endeavors and partnered with NCI to field HINTS-FDA 2015. HINTS-FDA 2015 was a self-administered paper instrument sent by mail May 29 to September 8, 2015, using a random probability-based sample of U.S. postal addresses stratified by county-level smoking rates, with an oversampling of high and medium-high smoking strata to increase the yield of current smokers responding to the survey. The response rate for HINTS-FDA 2015 was 33% (N = 3,738). The yield of current smokers (n = 495) was lower than expected, but the sampling strategy achieved the goal of obtaining more former smokers (n = 1,132). Public-use HINTS-FDA 2015 data and supporting documentation have been available for download and secondary data analyses since June 2016 at http://hints.cancer.gov. NCI and FDA encourage the use of HINTS-FDA for health communication research and practice related to tobacco-related communications, public knowledge, and behaviors as well as beliefs and actions related to medical products and dietary supplements. PMID:27892827
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Blake, Kelly D; Portnoy, David B; Kaufman, Annette R; Lin, Chung-Tung Jordan; Lo, Serena C; Backlund, Eric; Cantor, David; Hicks, Lloyd; Lin, Amy; Caporaso, Andrew; Davis, Terisa; Moser, Richard P; Hesse, Bradford W
2016-12-01
The National Cancer Institute (NCI) developed the Health Information National Trends Survey (HINTS) to monitor population trends in cancer communication practices, information preferences, health risk behaviors, attitudes, and cancer knowledge. The U.S. Food and Drug Administration (FDA) recognized HINTS as a unique data resource for informing its health communication endeavors and partnered with NCI to field HINTS-FDA 2015. HINTS-FDA 2015 was a self-administered paper instrument sent by mail May 29 to September 8, 2015, using a random probability-based sample of U.S. postal addresses stratified by county-level smoking rates, with an oversampling of high and medium-high smoking strata to increase the yield of current smokers responding to the survey. The response rate for HINTS-FDA 2015 was 33% (N = 3,738). The yield of current smokers (n = 495) was lower than expected, but the sampling strategy achieved the goal of obtaining more former smokers (n = 1,132). Public-use HINTS-FDA 2015 data and supporting documentation have been available for download and secondary data analyses since June 2016 at http://hints.cancer.gov . NCI and FDA encourage the use of HINTS-FDA for health communication research and practice related to tobacco-related communications, public knowledge, and behaviors as well as beliefs and actions related to medical products and dietary supplements.
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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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76 FR 14028 - Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-15
... is reopening the comment period for the expected duration of the active negotiation phase to ensure... throughout the negotiation phase, FDA is reopening the comment period until June 30, 2011. FDA expects that the public component of the GDUF negotiations will be complete by the end of June 2011. Therefore, the...
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77 FR 76050 - Public Workshop on Minimal Residual Disease; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
... the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum... acute and chronic leukemia. The Office of Hematology and Oncology Products has explored, or plans to...
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77 FR 76051 - Public Workshop on Minimal Residual Disease; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
... the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum... in certain subtypes of acute and chronic leukemia. The Office of Hematology and Oncology Products...
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Use of data mining at the Food and Drug Administration.
Duggirala, Hesha J; Tonning, Joseph M; Smith, Ella; Bright, Roselie A; Baker, John D; Ball, Robert; Bell, Carlos; Bright-Ponte, Susan J; Botsis, Taxiarchis; Bouri, Khaled; Boyer, Marc; Burkhart, Keith; Condrey, G Steven; Chen, James J; Chirtel, Stuart; Filice, Ross W; Francis, Henry; Jiang, Hongying; Levine, Jonathan; Martin, David; Oladipo, Taiye; O'Neill, Rene; Palmer, Lee Anne M; Paredes, Antonio; Rochester, George; Sholtes, Deborah; Szarfman, Ana; Wong, Hui-Lee; Xu, Zhiheng; Kass-Hout, Taha
2016-03-01
This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA). We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities. Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the US.
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Environmental assessments and findings of no significant impact--FDA. Notice.
1998-05-18
The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.
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21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0556...: ``Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years;'' Request for... Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled...
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21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.
Code of Federal Regulations, 2012 CFR
2012-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...
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21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.
Code of Federal Regulations, 2014 CFR
2014-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...
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21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.
Code of Federal Regulations, 2010 CFR
2010-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0556... Institute of Medicine Report: ``Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at...; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the...
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21 CFR 314.150 - Withdrawal of approval of an application or abbreviated application.
Code of Federal Regulations, 2013 CFR
2013-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.150 Withdrawal of approval of an... abbreviated application for a new drug on a finding that there is an imminent hazard to the public health. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-10
... under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for... adhere to these principles, and performance goals for this program. FDA plans to review the comments... drug marketing applications were submitted each year for FDA review. The number of participants in the...
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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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... Surgical Clinics of North America; 83(5):1045-51, v-vi. 2 . http://www.facs.org/public_ ... FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products ...
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Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M
2017-12-05
To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-03
...: ``Designing for Impact: Workshop on Building the National Network for Manufacturing Innovation'' AGENCY...), housed at the National Institute of Standards and Technology (NIST), announces the first of a series of public workshops entitled ``Designing for Impact: Workshop on Building the National Network for...
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Applications of functional data analysis: A systematic review.
Ullah, Shahid; Finch, Caroline F
2013-03-19
Functional data analysis (FDA) is increasingly being used to better analyze, model and predict time series data. Key aspects of FDA include the choice of smoothing technique, data reduction, adjustment for clustering, functional linear modeling and forecasting methods. A systematic review using 11 electronic databases was conducted to identify FDA application studies published in the peer-review literature during 1995-2010. Papers reporting methodological considerations only were excluded, as were non-English articles. In total, 84 FDA application articles were identified; 75.0% of the reviewed articles have been published since 2005. Application of FDA has appeared in a large number of publications across various fields of sciences; the majority is related to biomedicine applications (21.4%). Overall, 72 studies (85.7%) provided information about the type of smoothing techniques used, with B-spline smoothing (29.8%) being the most popular. Functional principal component analysis (FPCA) for extracting information from functional data was reported in 51 (60.7%) studies. One-quarter (25.0%) of the published studies used functional linear models to describe relationships between explanatory and outcome variables and only 8.3% used FDA for forecasting time series data. Despite its clear benefits for analyzing time series data, full appreciation of the key features and value of FDA have been limited to date, though the applications show its relevance to many public health and biomedical problems. Wider application of FDA to all studies involving correlated measurements should allow better modeling of, and predictions from, such data in the future especially as FDA makes no a priori age and time effects assumptions.
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Applications of functional data analysis: A systematic review
2013-01-01
Background Functional data analysis (FDA) is increasingly being used to better analyze, model and predict time series data. Key aspects of FDA include the choice of smoothing technique, data reduction, adjustment for clustering, functional linear modeling and forecasting methods. Methods A systematic review using 11 electronic databases was conducted to identify FDA application studies published in the peer-review literature during 1995–2010. Papers reporting methodological considerations only were excluded, as were non-English articles. Results In total, 84 FDA application articles were identified; 75.0% of the reviewed articles have been published since 2005. Application of FDA has appeared in a large number of publications across various fields of sciences; the majority is related to biomedicine applications (21.4%). Overall, 72 studies (85.7%) provided information about the type of smoothing techniques used, with B-spline smoothing (29.8%) being the most popular. Functional principal component analysis (FPCA) for extracting information from functional data was reported in 51 (60.7%) studies. One-quarter (25.0%) of the published studies used functional linear models to describe relationships between explanatory and outcome variables and only 8.3% used FDA for forecasting time series data. Conclusions Despite its clear benefits for analyzing time series data, full appreciation of the key features and value of FDA have been limited to date, though the applications show its relevance to many public health and biomedical problems. Wider application of FDA to all studies involving correlated measurements should allow better modeling of, and predictions from, such data in the future especially as FDA makes no a priori age and time effects assumptions. PMID:23510439
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21 CFR 516.157 - Publication of the index and content of an index listing.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Publication of the index and content of an index listing. 516.157 Section 516.157 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... available through the FDA Web site. A printed copy can be obtained by writing to the FDA Freedom of...
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FDA regulation of tobacco: blessing or curse for FDA professionals?
O'Reilly, James T
2009-01-01
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
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Food and Drug Administration tobacco regulation and product judgments.
Kaufman, Annette R; Finney Rutten, Lila J; Parascandola, Mark; Blake, Kelly D; Augustson, Erik M
2015-04-01
The Family Smoking Prevention and Tobacco Control Act granted the Food and Drug Administration (FDA) the authority to regulate tobacco products in the U.S. However, little is known about how regulation may be related to judgments about tobacco product-related risks. To understand how FDA tobacco regulation beliefs are associated with judgments about tobacco product-related risks. The Health Information National Trends Survey is a national survey of the U.S. adult population. Data used in this analysis were collected from October 2012 through January 2013 (N=3,630) by mailed questionnaire and analyzed in 2013. Weighted bivariate chi-square analyses were used to assess associations among FDA regulation belief, tobacco harm judgments, sociodemographics, and smoking status. A weighted multinomial logistic regression was conducted where FDA regulation belief was regressed on tobacco product judgments, controlling for sociodemographic variables and smoking status. About 41% believed that the FDA regulates tobacco products in the U.S., 23.6% reported the FDA does not, and 35.3% did not know. Chi-square analyses showed that smoking status was significantly related to harm judgments about electronic cigarettes (p<0.0001). The multinomial logistic regression revealed that uncertainty about FDA regulation was associated with tobacco product harm judgment uncertainty. Tobacco product harm perceptions are associated with beliefs about tobacco product regulation by the FDA. These findings suggest the need for increased public awareness and understanding of the role of tobacco product regulation in protecting public health. Copyright © 2015. Published by Elsevier Inc.
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75 FR 8099 - Public Workshop on Marine Technology and Standards
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-23
... Technology and Standards AGENCY: Coast Guard, DHS. ACTION: Notice. SUMMARY: The American Society of...-day public workshop in Washington DC on marine technology and standards. This public workshop will provide a unique opportunity for classification societies, industry groups, standards development...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
...] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014... and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will... documents, FDA has committed to updating its Web site in a timely manner to reflect the Agency's review of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-08
... series of public workshops entitled ``Designing for Impact: Workshop on Building the National Network for... Education and Workforce Development. The Designing for Impact workshop series is organized by... series will be held on Monday, July 9, 2012 from 8:00 a.m. until 4:30 p.m. Eastern time. Event check-in...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-30
...] Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop AGENCY: Food and... Infusions.'' The purpose of the public workshop is to identify and discuss potential risk mitigation...) (Human) infusion. Complications of hemolysis include severe anemia requiring transfusion, renal failure...
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75 FR 49502 - Medical Device User Fee Act; Public Meeting; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-13
... Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the...)) requires that, before FDA begins negotiations with the regulated industry on user fee reauthorization, we...
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Leonard, Elizabeth Weeks
2009-01-01
On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
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77 FR 49447 - Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-16
...] Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop AGENCY: Food and Drug... public workshop to discuss the endpoints for clinical trials of drugs and therapeutic biologics in kidney... trials of kidney transplantation. The meeting will include a discussion of measure of patient and graft...
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78 FR 56268 - Pipeline Safety: Public Workshop on Integrity Verification Process, Comment Extension
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-12
.... PHMSA-2013-0119] Pipeline Safety: Public Workshop on Integrity Verification Process, Comment Extension... public workshop on ``Integrity Verification Process'' which took place on August 7, 2013. The notice also sought comments on the proposed ``Integrity Verification Process.'' In response to the comments received...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-13
...] Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments... Cardiovascular Devices 30-Day Notices and Annual Reports.'' This public workshop will be cosponsored with... approval applications (PMAs), 30-day notices and annual reports, specifically for cardiovascular devices...
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Life cycle of medical product rules issued by the US Food and Drug Administration.
Hwang, Thomas J; Avorn, Jerry; Kesselheim, Aaron S
2014-08-01
The US Food and Drug Administration (FDA) uses rulemaking as one of its primary tools to protect the public health and implement laws enacted by Congress and the president. Because of the many effects that these rules have on social welfare and the economy, the FDA and other executive agencies receive input from the executive branch, the public, and in some cases, the courts, during the process of rulemaking. In this article, we examine the life cycle of FDA regulations concerning medical products and review notable features of the rulemaking process. The current system grants substantial opportunities for diverse stakeholders to participate in and influence how rules are written and implemented. However, the duration, complexity, and adversarial qualities of the rulemaking process can hinder the FDA's ability to achieve its policy and public health goals. There is considerable variation in the level of transparency at different stages in the process, ranging from freely accessible public comments to undisclosed internal agency deliberations. In addition, significant medical product rules are associated with lengthy times to finalization, in some cases for unclear reasons. We conclude by identifying potential areas for reform on the basis of transparency and efficiency. Copyright © 2014 by Duke University Press.
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78 FR 12763 - Fecal Microbiota for Transplantation; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-25
... public workshop will be provided on a space available basis beginning at 8 a.m. If you need special... this workshop to provide a forum for the exchange of information, knowledge, and experience between...
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Ramsingh, R; Mills, C J
1997-01-01
The objective of this paper is to assess the impact of the 1994 Workshop on Public Education Messages for Reducing Health Risks from Ultraviolet Radiation (UVR). The target audience was any organization in Canada doing education on the health risks of UVR. A mailed survey with telephone follow-up was distributed to 130 addresses, including workshop participants, recipients of the workshop report and 40 local public health units. The response rate was 62%. Public health messages from the workshop served as an added impetus or helped to initiate activities around UVR in approximately 40% of organizations over the two years since the workshop. The public health messages were used directly in programming by approximately 38% of all organizations responding. However, looking at those who had previously seen the messages, 61% used them directly in programming. Forty percent of those sampled had never seen a copy of the messages. The results suggest the need for improved dissemination of consensus statements.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-19
...] Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop AGENCY: Food... outcomes in kidney transplantation. This public workshop is intended to obtain information from health care... for the prophylaxis and/or treatment of delayed graft function (DGF) and related conditions in kidney...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-23
...] Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop; Request for... Issues in Developing Drug and Biological Products for Rare Diseases.'' The purpose of the public workshop is twofold: To discuss complex issues in clinical trials for developing drug and biological products...
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75 FR 54351 - Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-07
...] Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop AGENCY: Food and Drug... Biologics Evaluation and Research (CBER) is announcing a public workshop entitled ``Cell and Gene Therapy... regarding best practices related to cell and gene therapy clinical trials in pediatric populations, as well...
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The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.
Sinha, Michael S; Kesselheim, Aaron S
2018-05-01
In a Guest Editorial, Aaron S. Kesselheim and Michael S. Sinha show how federal and state legislation to allow promotion of drugs for non-approved uses threatens to undermine the FDA's public health mission.
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78 FR 30964 - Pipeline Safety: Workshop on Public Awareness Programs
Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-23
...-day public awareness workshop on June 19 and June 20, 2013, at the Hyatt Regency North Dallas hotel in.... until approximately 5:00 p.m. central time, both days. Refer to the meeting Web site for agenda and... workshop presentations will be available on the meeting Web site within 15 days following the workshop...
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Miller, Jennifer E; Korn, David; Ross, Joseph S
2015-01-01
Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge. PMID:26563214
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-07
...The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. Clinical trials are a critical source of evidence to inform medical policy and practice, and effective regulatory oversight is needed to ensure that human subjects are protected and resulting clinical trial data are credible and accurate. FDA is aware of concerns within the clinical trial community that certain regulations and policies applicable to the conduct of clinical trials may result in inefficiencies or increased cost and may not facilitate the use of innovative methods and technological advances to improve clinical trial quality. The Agency is involved in an effort to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP). The purpose of this hearing is to solicit public input from a broad group of stakeholders on the scope and direction of this effort, including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise.
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Chambers, James D; May, Katherine E; Neumann, Peter J
2013-06-01
The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-02
...] Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public... Neurocognitive Assessments for Cardiovascular Devices.'' The purpose of the public workshop is to solicit... various neurological and neurocognitive assessments for pediatric patients implanted with cardiovascular...
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Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan
2016-01-01
Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.
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Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study.
Vitry, Agnes; Nguyen, Tuan; Entwistle, Vikky; Roughead, Elizabeth
2015-01-01
Withdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. We present a case study of the US Food and Drug Administration (FDA)'s decision to withdraw the indication of bevacizumab for the treatment of advanced breast cancer and include an analysis of the reactions of stakeholders with a view to identifying opportunities for improving risk management for new medicines with conditional approval or funding. We drew on a range of information sources, including FDA documents, medical journals and media reports, to describe the evidentiary basis of the FDA decisions. We analysed the reactions and perspectives of the stakeholders. In 2008 bevacizumab was granted conditional approval for treatment of advanced breast cancer by the FDA pending submission of supplementary satisfactory evidence. In 2011 the FDA decision to withdraw the indication was met with a hostile reaction from many clinicians and cancer survivors. There were different interpretations of the therapeutic value of bevacizumab with strong beliefs among cancer survivors that the medicine was effective and potential harm was manageable. High expectations of the public may have been encouraged by overly positive media reports and limited understanding by the public of the complexity of the scientific evaluation of new medicines and of the regulatory processes. Improving understanding and acceptance of approval or coverage schemes conditional to evidence development may require the development of risk management plans by regulatory and funding institutions. They may include a range of strategies such as requirements for formal patient acknowledgment of the conditional availability of the medicine, 'black-triangle' equivalent labels that identify full approval is based on pending evidence, and ongoing communication with the media, public and health professionals.
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DOT National Transportation Integrated Search
2000-01-01
This document contains information about a Public Sector Workshop held in Minnesota that focused on increasing the awareness of Intelligent Transportation Systems (ITS) standards. It gives an overview of how the workshop proceeded, which topics were ...
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New technology in electrophysiology: FDA process and perspective.
Selzman, Kimberly A; Fellman, Mark; Farb, Andrew; de Del Castillo, Sergio; Zuckerman, Bram
2016-10-01
The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.
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Incentives for orphan drug research and development in the United States.
Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Szeinbach, Sheryl L; Visaria, Jay
2008-12-16
The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.
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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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Code of Federal Regulations, 2010 CFR
2010-04-01
... § 10.204 General. (a) FDA has for many years willingly committed itself to a policy of openness. In many instances FDA has sought to make the open portions of agency public administrative proceedings... proceeding. Knowledge of anticipated media coverage will allow the presiding officer to make any special...
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76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a...
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77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-26
... barriers such as prevention or warning fatigue or inaccurate risk perception. FDA intends to make...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Risk...
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Regulating nanomedicine - can the FDA handle it?
Bawa, Raj
2011-05-01
There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle nanomedicine research and development (R&D) and erode public acceptance of nanoproducts. The end-result of this could be a delay or loss of commercialized nanoproducts. Whether the FDA eventually creates new regulations, tweaks existing ones or establishes a new regulatory center to handle nanoproducts, for the time being it should at least look at nanoproducts on a case-by-case basis. The FDA should not attempt regulation of nanomedicine by applying existing statutes alone, especially where scientific evidence suggests otherwise. Incorporating nanomedicine regulation into the current regulatory scheme is a poor idea. Regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection and safety.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-17
...The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements, including third party disclosure, contained in FDA's regulations on prescription drug advertisements.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-08
... Guidance Document: Labeling for Natural Rubber Latex Condoms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0492...
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75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...
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78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...
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77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...
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78 FR 2677 - Blood Products Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-12
... protection of public health, safety, and ethical standards, FDA has established human subject protection... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0560... Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually...
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76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0380...: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...
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78 FR 16401 - Institutional Review Boards; Correcting Amendments
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-15
... Administration, HHS. ACTION: Final rule; correcting amendments. SUMMARY: The Food and Drug Administration (FDA... the regulatory text and to update contact information. This action is editorial in nature and is... action under the Administrative Procedures Act (5 U.S.C. 553). FDA has determined that notice and public...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0172... Not Conducted Under an Investigational New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0430... Food/Feed Facility Profile Information AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0110...: Manufacturer, Importer, User Facility, and Distributor Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...
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78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-19
... recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by... performance of a tobacco product), packing, and storage of a tobacco product conform to current good... group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice...
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78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-05
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0731... Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0101... Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...
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75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory...
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78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...
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75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...
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76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...
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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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EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future
Largent, Emily A.
2016-01-01
Abstract In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments, sparked calls to use experimental interventions in the field, and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it showcased FDA's global role in drug development, approval, and access. FDA's response to EVD highlights the panoply of agency powers and demonstrates the flexibility of FDA's regulatory framework. This paper evaluates the strengths and weaknesses of FDA's response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats. In particular, it argues that greater emphasis should be placed on drug development in interoutbreak periods and on assuring access to approved products. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response. PMID:28852537
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Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G
2015-04-01
The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.
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Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D
2014-10-01
Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.
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Downing, Nicholas S; Shah, Nilay D; Neiman, Joseph H; Aminawung, Jenerius A; Krumholz, Harlan M; Ross, Joseph S
2016-04-14
Pivotal trials, the clinical studies that inform U.S. Food and Drug Administration (FDA) approval decisions, provide the foundational evidence supporting the safety and efficacy of novel therapeutics. We determined the representation of the elderly, women, and patients from racial and ethnic minorities in pivotal trials and whether the FDA is making subgroup efficacy analyses among these subpopulations available to the public. We conducted a cross-sectional study of novel therapeutics approved by the FDA between 2011 and 2013. Using publicly available FDA documents, we collected information on the demographic characteristics of pivotal trial participants (age ≥65 years, sex [male, female], race [white, black, Asian, other], and ethnicity [Hispanic, non-Hispanic]) and determined the availability of subgroup analyses by age, sex, race, and ethnicity. We identified 86 novel therapeutic that were approved by the FDA between 2011 and 2013 for 92 indications on the basis of 206 pivotal trials. The median age of pivotal trial patients was 53.1 years (interquartile range 40.6-60.6), and the mean proportion of patients ≥65 years of age was 28.9 % (95 % CI 23.5-34.4 %). Similar proportions of pivotal trial participants were male (mean 50.3 %, 95 % CI 45.3-55.2 %) and female (mean 49.7 %, 95 % CI 44.7-54.7 %). Most participants were white (mean 79.2 %, 95 % CI 75.9-82.6 %), while the mean proportion of black patients was 7.4 % (95 % CI 5.5-9.3 %), that of Asian patients was 7.4 % (95 % CI 5.2-9.7 %), and that of patients of other races was 5.9 % (95 % CI 4.4-7.5 %). Information about ethnicity was available for only 59.8 % of indications, and where such data were available, the mean proportion of Hispanic participants was 13.3 % (95 % CI 10.3-16.3 %). FDA reviewers performed and made available subgroup efficacy analyses by age, sex, and race for at least one of the pivotal trials used as the basis of approval for over 80 % of indications. Although women are equally represented in pivotal trials supporting recent novel therapeutic approvals by the FDA, elderly patients and those from racial and ethnic minorities are underrepresented. FDA reviewers generally perform subgroup efficacy analyses by age, sex, and race and make these subgroup analyses available to the public.
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Enhancing Your Library's Public Relations with "Lunch-and-Learn" Workshops.
ERIC Educational Resources Information Center
Godbey, Ruth
The staff of the Creighton University (Omaha, Nebraska) Health Sciences Library has been able to improve not only the library's public relations but also the image of the library by presenting weekly "Lunch-and-Learn" workshops. Since 1990, approximately 15 workshops have been presented each semester with topics ranging from cancer…
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DOT National Transportation Integrated Search
2012-06-08
This report provides a summary and overview of the Public Workshop entitled, Enabling a Secure Environment for Vehicle-to-Vehicle and Vehicle-to-Infrastructure Transactions, presented by USDOT. The workshop took place on April 19-20, 2012 at th...
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ENVIRONMENTAL PUBLIC HEALTH OUTCOMES WORKSHOP PROCEEDINGS -RESEARCH TRIANGLE PARK, NC, 7/30-31/2002
To better define ORD's Environmental Public Health Outcomes (EPHO) research agenda, a workshop was held 7/30-31/2002 at EPA facilities in Research Triangle Park, NC. The intent of this workshop was to engage federal and other organizations in a dialog that will assist ORD in deve...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-15
... Atlantic stock of black sea bass and golden tilefish will consist of a series of three workshops: A Data Workshop, an Assessment Workshop, and a Review Workshop. The Review Workshop date, time, and location will...
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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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77 FR 55845 - Anti-Infective Drugs Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-11
... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anti... indication of treatment of inhalational anthrax. FDA intends to make background material available to the... of the general nature of the evidence or arguments they wish to present, the names and addresses of...
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DMSO, Hobby Shops and the FDA: The Diffusion of a Health Policy Dilemma.
ERIC Educational Resources Information Center
Weinstock, Edward; Davis, Phillip
1985-01-01
Despite being banned by the FDA, DMSO (dimethyl sulfoxide) usage has spread rapidly among arthritic victims and weekend athletes. This study looked at current and past users to learn how they discovered DMSO, their reactions to buying an illegal drug, and possible implications for public health policy. (MT)
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77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2012-N-0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science...
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75 FR 59732 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...
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21 CFR 60.40 - Request for hearing.
Code of Federal Regulations, 2010 CFR
2010-04-01
... RESTORATION Due Diligence Hearings § 60.40 Request for hearing. (a) Any person may request, not later than 60 days after the publication under § 60.34(a) of FDA's due diligence determination, that FDA conduct an informal hearing on the due diligence determination. (b) The request for a hearing under this section shall...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0356... Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1432... Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0411... Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...
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76 FR 56201 - Prescription Drug User Fee Act; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-12
... PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect... and upgrade its information technology systems. At the same time, FDA committed to complete reviews in...\\ Since PDUFA was enacted, the median approval time of original NDAs and BLAs has been reduced by about 50...
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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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Lunar Commercialization Workshop
NASA Technical Reports Server (NTRS)
Martin, Gary L.
2008-01-01
This slide presentation describes the goals and rules of the workshop on Lunar Commercialization. The goal of the workshop is to explore the viability of using public-private partnerships to open the new space frontier. The bulk of the workshop was a team competition to create a innovative business plan for the commercialization of the moon. The public private partnership concept is reviewed, and the open architecture as an infrastructure for potential external cooperation. Some possible lunar commercialization elements are reviewed.
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Salas, Maribel; Martin, Michelle; Pisu, Maria; McCall, Erin; Zuluaga, Alvaro; Glasser, Stephen P
2008-03-01
Recent studies have suggested that there has been an increase in the number of 'warning letters' issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion. All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached. Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims. There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines. We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the main causes of FDA issued warning letters for promotional claims related to medications.
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41 CFR 60-741.47 - Sheltered workshops.
Code of Federal Regulations, 2014 CFR
2014-07-01
... sheltered workshops may be included within an affirmative action program if the sheltered workshop trains... 41 Public Contracts and Property Management 1 2014-07-01 2014-07-01 false Sheltered workshops. 60... REGARDING INDIVIDUALS WITH DISABILITIES Affirmative Action Program § 60-741.47 Sheltered workshops...
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Antiperspirant drug products for over-the-counter human use; final monograph. Final rule.
2003-06-09
The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention.
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Rathi, Vinay K; Gadkaree, Shekhar K; Ross, Joseph S; Kozin, Elliott D; Sethi, Rosh K; Naunheim, Matthew R; Puram, Sidharth V; Gray, Stacey T
2017-10-01
Objective The US Food and Drug Administration (FDA) clears moderate-risk devices via the 510(k) process based on substantial equivalence to previously cleared devices; evidence of safety and effectiveness is not required. We characterized the premarket evidence supporting FDA clearance of otolaryngologic devices. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects and Methods Recently cleared (1997-2016) moderate-risk otolaryngologic devices were categorized by type (diagnostic/therapeutic), subspecialty, implantable designation (yes/no), and recall history (yes/no). Supporting evidence was categorized by type (clinical/nonclinical/none; nonclinical and clinical mutually inclusive) and public availability of nonclinical and clinical performance data (available/not provided/not applicable). Results Between 1997 and 2016, the FDA cleared 377 moderate-risk otolaryngologic devices. The majority were therapeutic (n = 240/377 [63.7%]) and otologic (n = 311/377 [82.5%]); roughly one-third (n = 121/377 [32.1%]) were implantable. Few (n = 10/377 [2.7%]) devices were subject to recall. FDA documents summarizing premarket evidence were accessible for two-thirds (n = 247/377 [65.5%]) of devices. Among these devices, one-quarter (n = 66/247 [26.7%]) were supported by clinical evidence. The majority (n = 177/247 [71.7%]) were supported by nonclinical evidence, although nearly one-quarter (n = 58/247 [23.5%]) were cleared without supporting evidence. Therapeutic devices were more often cleared without supporting evidence (therapeutic: n = 53/170 [31.2%]; diagnostic: n = 5/77 [6.5%]; P < .0001). Nonclinical and clinical performance data were rarely available (nonclinical: n = 49/247 [19.8%]; clinical: n = 32/247 [13.0%]) within public summaries. Conclusion The FDA cleared most moderate-risk otolaryngologic devices for marketing via the 510(k) process without clinical evidence of safety and effectiveness. Otolaryngologists should be aware of limitations in premarket evidence when considering the adoption of new devices into clinical practice.
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Lutgring, Joseph D; Machado, María-José; Benahmed, Faiza H; Conville, Patricia; Shawar, Ribhi M; Patel, Jean; Brown, Allison C
2018-02-01
The FDA-CDC Antimicrobial Resistance Isolate Bank was created in July 2015 as a publicly available resource to combat antimicrobial resistance. It is a curated repository of bacterial isolates with an assortment of clinically important resistance mechanisms that have been phenotypically and genotypically characterized. In the first 2 years of operation, the bank offered 14 panels comprising 496 unique isolates and had filled 486 orders from 394 institutions throughout the United States. New panels are being added. Copyright © 2018 American Society for Microbiology.
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Impact of After-School Nutrition Workshops in a Public Library Setting
ERIC Educational Resources Information Center
Freedman, Marjorie R.; Nickell, Audrey
2010-01-01
Objective: To determine if after-school nutrition workshops conducted in public libraries were related to lasting changes in food choice. Methods: "Snack Smart" workshops, based on Social Cognitive Theory, were conducted in 8 branch libraries (49 ethnically diverse children, ages 9 to 14) to assess changes in consumption of targeted food items by…
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Steinert, Yvonne; McLeod, Peter J; Liben, Stephen; Snell, Linda
2008-01-01
Although educational innovations in medical education are increasing in number, many educators do not submit their ideas for publication. The goal of this initiative was to assist faculty members write about their educational innovations. Twenty-four faculty members participated in this intervention, which consisted of a half-day workshop, three peer writing groups, and independent study. We assessed the impact of this intervention through post-workshop evaluations, a one-year follow-up questionnaire, tracking of manuscript submissions, and an analysis of curriculum vitae. The workshop evaluations and one-year follow-up demonstrated that participants valued the workshop small groups, self-instructional workbook, and peer support and feedback provided by the peer writing groups. One year later, nine participants submitted a total of 14 manuscripts, 11 of which were accepted for publication. In addition, 10 participants presented a total of 38 abstracts at educational meetings. Five years later, we reviewed the curriculum vitae of all participants who had published or presented their educational innovation. Although the total number of publications remained the same, the number of educationally-related publications and presentations at scientific meetings increased considerably. A faculty development workshop and peer writing group can facilitate writing productivity and presentations of scholarly work in medical education.
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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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77 FR 31329 - Northeast Fisheries Science Center, Woods, Hole, MA; Public Meeting/Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-25
... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Northeast Fisheries Science Center, Woods, Hole, MA; Public Meeting/Workshop AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of a public meeting...
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A Workshop on High Energy Astrophysical for Amateur Astronomers
NASA Technical Reports Server (NTRS)
Fishman, Gerald J.; Mattei, J. A.; Rose, M. Franklin (Technical Monitor)
2000-01-01
Amateur astronomers are, in general, an enthusiastic and dynamic group of individuals who can help greatly in astronomy public outreach and education programs. In the U.S., they outnumber professional astronomers by over a factor of ten. Over eighty amateur astronomers from all over the U.S. and abroad attended a unique workshop in Huntsville, Alabama in April of this year. Most attendees were provided with travel grants under the condition that they disseminate knowledge gained at the workshop to civic groups, astronomy clubs and science teacher groups in their home communities. Twelve lecturers were given over two days, primarily by active high-energy researchers from NASA-MSFC and NASA-GSFC. Funding for the workshop was provided by a variety of NASA-sponsored projects, offices within OSS and private funding sources. The workshop attendees were selected by the AAVSO, which also administered the funding for the workshop. This high-leverage educational and public outreach program was deemed to be highly successful and bodes well for similar, future workshops. Many of the participants have already begun to give public talks on HEA and GRBs.
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77 FR 26509 - Notice of Public Meeting-Cloud Computing Forum & Workshop V
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-04
...--Cloud Computing Forum & Workshop V AGENCY: National Institute of Standards & Technology (NIST), Commerce. ACTION: Notice. SUMMARY: NIST announces the Cloud Computing Forum & Workshop V to be held on Tuesday... workshop. This workshop will provide information on the U.S. Government (USG) Cloud Computing Technology...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-27
..., clinical studies conducted to demonstrate superiority to a control, instead of non- inferiority to a... will include no more than 10 non-FDA participants. Only one participant from an organization or company will be assigned to the discussion group. FDA will attempt to have a range of constituencies...
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78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...
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75 FR 69093 - Prescription Drug User Fee Act; Reopening of the Comment Period
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-10
... review program after negotiations with the regulated industry conclude. FDA expects that this additional...)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires that before FDA begins negotiations with the... requires public review of the recommendations for the human drug review program after negotiations with the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...; Notice of Meeting. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-10
... public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and... assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA...). The draft guidance, when finalized, will represent the Agency's current thinking on ``Generic Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name... is 214- 651-1234. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and...
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Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
2006-01-17
The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.
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76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-09
...] Medical Device Innovation Initiative; Public Meeting; Request for Comments AGENCY: Food and Drug... Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public... Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative...
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NASA Technical Reports Server (NTRS)
Kim, Yunjin (Editor)
1996-01-01
This publication contains the summaries for the Sixth Annual JPL Airborne Earth Science Workshop, held in Pasadena, California, on March 4-8, 1996. The main workshop is divided into two smaller workshops as follows: The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on March 4-6. The summaries for this workshop appear in Volume 1. The Airborne Synthetic Aperture Radar (AIRSAR) workshop, on March 6-8. The summaries for this workshop appear in Volume 2.
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Summaries of the Sixth Annual JPL Airborne Earth Science Workshop. Volume 1; AVIRIS Workshop
NASA Technical Reports Server (NTRS)
Green, Robert O. (Editor)
1996-01-01
This publication contains the summaries for the Sixth Annual JPL Airborne Earth Science Workshop, held in Pasadena, California, on March 4-8, 1996. The main workshop is divided into two smaller workshops as follows: (1) The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on March 4-6. The summaries for this workshop appear in Volume 1; (2) The Airborne Synthetic Aperture Radar (AIRSAR) workshop, on March 6-8. The summaries for this workshop appear in Volume 2.
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Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity
Benjamin, Daniel Kelly; Smith, Philip Brian; Murphy, M. Dianne; Roberts, Rosemary; Mathis, Lisa; Avant, Debbie; Califf, Robert M; Li, Jennifer S.
2009-01-01
Context Much of pediatric drug use is “off-label” because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children. In 1997, Congress authorized FDA to grant extensions of marketing rights known as “pediatric exclusivity” if FDA-requested pediatric trials were conducted. As a result, there have been over 100 product labeling changes. The publication status of studies completed for pediatric exclusivity has not been evaluated. Objective To quantify the dissemination of results of studies conducted for pediatric exclusivity into the peer-review literature. Design Cohort study of all trials conducted for Pediatric Exclusivity, the subsequent labeling changes, and the publication of those studies in peer-reviewed journals. We categorized each study in the exclusivity application as ”successful” or “unsuccessful” based on FDA approval of the indication sought by the sponsor. We categorized any labeling changes resulting from the studies as ”positive” or “negative” for the drug under study. We then evaluated aspects of the studies and product label changes that were associated with subsequent publication in peer-reviewed medical journals. Main Outcome Measures Publication of the trial data in peer-reviewed journals. Results Between 1998 and 2004, 253 studies were submitted to FDA for pediatric exclusivity: 50% evaluated efficacy, 20% were multi-dose pharmacokinetic, 13% were single-dose pharmacokinetic, and 17% were safety studies. Labeling changes were positive for 127/253 (50%) of studies; only 112/253 (44%) were published. Efficacy studies and those with a favorable labeling change were more likely to be published. Of 100 studies resulting in important labeling changes, only 33 were published. Conclusions The pediatric exclusivity program has been successful in encouraging drug studies in children. However, the dissemination of these results in the peer-reviewed literature is limited. The results of these trials and future studies conducted for pediatric exclusivity should be published in peer-reviewed journals. Mechanisms to more widely disperse this information warrant further evaluation. PMID:16968851
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1993-07-27
The Food and Drug Administration (FDA) is announcing that it is establishing a public docket for policy speeches, policy statements, and standard operating procedure guides pertaining to product evaluation and regulatory enforcement for its medical device and radiological health programs. The docket will operate on a 1-year trial basis and will serve both as a repository for critical policy documents generated by the Center for Devices and Radiological Health (CDRH) and as a public display mechanism for access by representatives of the industry and other interested persons. This action is one element of an overall communications initiative to ensure uniform and timely access to important information.
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Game-Coding Workshops in New Zealand Public Libraries: Evaluation of a Pilot Project
ERIC Educational Resources Information Center
Bolstad, Rachel
2016-01-01
This report evaluates a game coding workshop offered to young people and adults in seven public libraries round New Zealand. Participants were taken step by step through the process of creating their own simple 2D videogame, learning the basics of coding, computational thinking, and digital game design. The workshops were free and drew 426 people…
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General Public Space Travel and Tourism. Volume 2; Workshop Proceedings
NASA Technical Reports Server (NTRS)
ONeil, D. (Compiler); Mankins, J. (Editor); Bekey, I. (Editor); Rogers, T. (Editor); Stallmer, E. (Editor); Piland, W. (Editor)
1999-01-01
The Space Transportation Association and NASA conducted a General Public Space Travel study between 1996 and 1998. During the study, a workshop was held at Georgetown University. Participants included representatives from the travel, aerospace, and construction industries. This report is the proceedings from that workshop. Sections include infrastructure needs, travel packages, policy related issues, and potential near-term activities.
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The Drug Facts Box: Improving the communication of prescription drug information.
Schwartz, Lisa M; Woloshin, Steven
2013-08-20
Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.
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The Drug Facts Box: Improving the communication of prescription drug information
Schwartz, Lisa M.; Woloshin, Steven
2013-01-01
Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130
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Wang, An-Li; Romer, Dan; Elman, Igor; Turetsky, Bruce I.; Gur, Ruben C.; Langleben, Daniel D.
2015-01-01
There is an ongoing public debate about the new graphic warning labels (GWLs) that the Food and Drug Administration (FDA) proposes to place on cigarette packs. Tobacco companies argued that the strongly emotional images FDA proposed to include in the GWLs encroached on their constitutional rights. The court ruled that FDA did not provide sufficient scientific evidence of compelling public interest in such encroachment. This study’s objectives were to examine the effects of the GWLs on the electrophysiological and behavioral correlates of smoking addiction and to determine whether labels rated higher on the emotional reaction (ER) scale are associated with greater effects. We studied 25 non-treatment-seeking smokers. Event-related potentials (ERPs) were recorded while participants viewed a random sequence of paired images, in which visual smoking (Cues) or non-smoking (non-Cues) images were preceded by GWLs or neutral images. Participants reported their cigarette craving after viewing each pair. Dependent variables were magnitude of P300 ERPs and self-reported cigarette craving in response to Cues. We found that subjective craving response to Cues was significantly reduced by preceding GWLs, whereas the P300 amplitude response to Cues was reduced only by preceding GWLs rated high on the ER scale. In conclusion, our study provides experimental neuroscience evidence that weighs in on the ongoing public and legal debate about how to balance the constitutional and public health aspects of the FDA-proposed GWLs. The high toll of smoking-related illness and death adds urgency to the debate and prompts consideration of our findings while longitudinal studies of GWLs are underway. PMID:24330194
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Holden, Mark
2015-01-01
This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-02
...), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking: Announcement of a public technical... this proposal. The first event, a public technical workshop, will be held on March 11, 2011, to discuss technical issues relevant to the test procedure described in the proposed rule. The second event, a public...
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Improving risk communication through interactive training in communication skills
DOE Office of Scientific and Technical Information (OSTI.GOV)
White, D.A.; White, R.K.
1990-01-01
This paper describes a workshop in communication and public speaking skills recently conducted for a group of public officials whose responsibilities include presenting risk information at public meetings associated with hazardous waste sites. We detail the development and execution of the 2 1/2 day workshop, including the development and integration of a 45-minute video of a simulated public meeting used to illustrate examples of good and bad communication behaviors. The workshop uses a mock public meeting video, participatory video exercises, role-playing, and instructor, and a resource text. This interactive approach to teaching communication skills can help sensitize scientists to themore » public's understanding of risk and improve scientists' confidence and effectiveness in communicating scientific information. 10 refs., 1 fig.« less
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Public reactions to e-cigarette regulations on Twitter: a text mining analysis.
Lazard, Allison J; Wilcox, Gary B; Tuttle, Hannah M; Glowacki, Elizabeth M; Pikowski, Jessica
2017-12-01
In May 2016, the Food and Drug Administration (FDA) issued a final rule that deemed e-cigarettes to be within their regulatory authority as a tobacco product. News and opinions about the regulation were shared on social media platforms, such as Twitter, which can play an important role in shaping the public's attitudes. We analysed information shared on Twitter for insights into initial public reactions. A text mining approach was used to uncover important topics among reactions to the e-cigarette regulations on Twitter. SAS Text Miner V.12.1 software was used for descriptive text mining to uncover the primary topics from tweets collected from May 1 to May 17 2016 using NUVI software to gather the data. A total of nine topics were generated. These topics reveal initial reactions to whether the FDA's e-cigarette regulations will benefit or harm public health, how the regulations will impact the emerging e-cigarette market and efforts to share the news. The topics were dominated by negative or mixed reactions. In the days following the FDA's announcement of the new deeming regulations, the public reaction on Twitter was largely negative. Public health advocates should consider using social media outlets to better communicate the policy's intentions, reach and potential impact for public good to create a more balanced conversation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Amendment to examination and investigation sample requirements--FDA. Direct final rule.
1998-09-25
The Food and Drug Administration (FDA) is amending its regulations regarding the collection of twice the quantity of food, drug, or cosmetic estimated to be sufficient for analysis. This action increases the dollar amount that FDA will consider to determine whether to routinely collect a reserve sample of a food, drug, or cosmetic product in addition to the quantity sufficient for analysis. Experience has demonstrated that the current dollar amount does not adequately cover the cost of most quantities sufficient for analysis plus reserve samples. This direct final rule is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on food, drugs, and cosmetics without diminishing the protection of the public health. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws this direct final rule.
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Summaries of the 4th Annual JPL Airborne Geoscience Workshop. Volume 1: AVIRIS Workshop
NASA Technical Reports Server (NTRS)
Green, Robert O. (Editor)
1993-01-01
This publication contains the summaries for the Fourth Annual JPL Airborne Geoscience Workshop, held in Washington, D. C. October 25-29, 1993 The main workshop is divided into three smaller workshops as follows: The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, October 25-26 (the summaries for this workshop appear in this volume, Volume 1); The Thermal Infrared Multispectral Scanner (TMIS) workshop, on October 27 (the summaries for this workshop appear in Volume 2); and The Airborne Synthetic Aperture Radar (AIRSAR) workshop, October 28-29 (the summaries for this workshop appear in Volume 3).
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Blueprint for prescriber continuing education program.
2012-06-01
On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.
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This publication is the result of a workshop and it is intended for publication through the SETAC Special Publication Series based on the proceedings from the SETAC sponsored workshop that was titles "Toxicity Identification Evaluation (TIE) Forum: What Works, What Doesn't, ...
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76 FR 34994 - Vaccine To Protect Children From Anthrax-Public Engagement Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-15
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Vaccine To Protect Children From Anthrax--Public.... SUMMARY: The National Biodefense Science Board's (NBSB) Anthrax Vaccine (AV) Working Group (WG) will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-29
... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 199-205] South Carolina Public Service Authority; Notice of Workshop for Santee Cooper Hydroelectric Project On May 26 and...) and the South Carolina Public Service Authority (SCPSA), licensee for the Santee-Cooper Hydroelectric...
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Company stock prices before and after public announcements related to oncology drugs.
Rothenstein, Jeffrey M; Tomlinson, George; Tannock, Ian F; Detsky, Allan S
2011-10-19
Phase III clinical trials and Food and Drug Administration (FDA) regulatory decisions are critical for success of new drugs and can influence a company's market valuation. Knowledge of trial results before they are made public (ie, "inside information") can affect the price of a drug company's stock. We examined the stock prices of companies before and after public announcements regarding experimental anticancer drugs owned by the companies. We identified drugs that were undergoing evaluation in phase III trials or for regulatory approval by the US FDA from January 2000 to January 2009. Stock prices of companies that owned such drugs were analyzed for 120 trading days before and after the first public announcement of 1) results of clinical trials with positive and negative outcomes and 2) positive and negative regulatory decisions. All statistical tests were two-sided. We identified public announcements from 23 positive trials and 36 negative trials and from 41 positive and nine negative FDA regulatory decisions. The mean stock price for the 120 trading days before a phase III clinical trial announcement increased by 13.7% (95% confidence interval = -2.2% to 29.6%) for companies that reported positive trials and decreased by 0.7% (95% confidence interval = -13.8% to 12.3%) for companies that reported negative trials (P = .09). In a post hoc analysis comparing the stock price averaged over 60 trading days before and after day -60 relative to the clinical trial announcement, the mean stock price increased by 9.4% for companies that reported positive trials and decreased by 4.5% for companies that reported negative trials (P = .03). Changes in company stock prices before FDA regulatory decisions did not differ statistically between companies with positive decision and companies with negative decisions. Trends in company stock prices before the first public announcement differ for companies that report positive vs negative trials. This finding has important legal and ethical implications for investigators, drug companies, and the investment industry.
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Array Funded Projects Geochronology Synthesis Workshops Scientific Publications Science Nuggets ES Synthesis Workshop 06-12 | 06-14 IRIS Workshop: Foundations, Frontiers, and Future Facilities for Seismology 06-15 | Call for Science Nuggets this spring! 07-26 | 07-28 Midcontinent Rift Synthesis Workshop See
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OMLTA Workshop Booklet, 1978-1979.
ERIC Educational Resources Information Center
Ohio Modern Language Teachers Association, Columbus.
This booklet is a guideline to those interested in the Ohio Modern Language Teachers Association Workshops. Outlined are the membership policies, responsibilities of the local workshop director, guidelines for selecting consultants, site selection, publicity guidelines, and OMLTA workshops and consultants. A complete description of each workshop…
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Regulation of prescription drug promotion: direct-to-consumer advertising.
Baylor-Henry, M; Drezin, N A
1998-01-01
The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.
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Dzanis, David A
2008-08-01
Pet foods on the market that are contaminated or otherwise present a health risk to humans or animals may be subject to a recall under US Food and Drug Administration (FDA) regulations. Legally, all recalls are "voluntary," but there is little incentive for companies to refuse a request by FDA to conduct a recall. While the firm does the bulk of the work, FDA oversees all aspects of a recall to help ensure that violative product is swiftly removed from the market. A recent new federal law will require FDA to improve its abilities to detect outbreaks of pet food-borne illness, respond to a contamination incident, and communicate with industry and the public on the matter of recalls. Veterinarians play a key role in detecting and reporting pet food-borne illness.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-31
... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Public Meeting... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179, and 211 [Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921] Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-13
... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Public Meeting... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179, and 211 [Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921] Food and...
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77 FR 7136 - Caribbean Fishery Management Council; Public Meetings
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-10
.../Sedar_Workshops.jsp?WorkshopNum=26 ) 5. Discussion of options paper on parrotfish size and trip limits 6... meetings are open to the public, and will be conducted in English. Simultaneous interpretation (English...
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The science of public messages for suicide prevention: a workshop summary.
Chambers, David A; Pearson, Jane L; Lubell, Keri; Brandon, Susan; O'brien, Kevin; Zinn, Janet
2005-04-01
There is minimal guidance for efforts to create effective public messages that increase awareness that suicide is preventable. To address this need, several agencies in the U.S. Department of Health and Human Services and the Annenberg Foundation convened a workshop consisting of suicide prevention advocates and persons with expertise in public health evaluation, suicide contagion, decision-making, and marketing. "Logic models" were used to define intended messages and audiences, assumed mechanisms of change, and outcomes. This summary describes some of the challenges and opportunities identified by workshop participants in evaluating public awareness campaigns in suicide prevention, technical assistance needs, and a proposed research agenda.
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77 FR 74829 - Notice of Public Meeting-Cloud Computing and Big Data Forum and Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-18
...--Cloud Computing and Big Data Forum and Workshop AGENCY: National Institute of Standards and Technology... Standards and Technology (NIST) announces a Cloud Computing and Big Data Forum and Workshop to be held on... followed by a one-day hands-on workshop. The NIST Cloud Computing and Big Data Forum and Workshop will...
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DIAPER INDUSTRY WORKSHOP REPORT
This report is the product of a one-day workshop on the diaper industry that was sponsored by the U.S. EPA. our topics covered during the workshop were public health and safety, recycling, composting, and product life cycle analysis. he primary objective of the workshop was to id...
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41 CFR 60-741.45 - Sheltered workshops.
Code of Federal Regulations, 2011 CFR
2011-07-01
... within an affirmative action program if the sheltered workshop trains employees for the contractor and... 41 Public Contracts and Property Management 1 2011-07-01 2009-07-01 true Sheltered workshops. 60... INDIVIDUALS WITH DISABILITIES Affirmative Action Program § 60-741.45 Sheltered workshops. Contracts with...
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41 CFR 60-741.45 - Sheltered workshops.
Code of Federal Regulations, 2010 CFR
2010-07-01
... within an affirmative action program if the sheltered workshop trains employees for the contractor and... 41 Public Contracts and Property Management 1 2010-07-01 2010-07-01 true Sheltered workshops. 60... INDIVIDUALS WITH DISABILITIES Affirmative Action Program § 60-741.45 Sheltered workshops. Contracts with...
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41 CFR 60-741.45 - Sheltered workshops.
Code of Federal Regulations, 2013 CFR
2013-07-01
... within an affirmative action program if the sheltered workshop trains employees for the contractor and... 41 Public Contracts and Property Management 1 2013-07-01 2013-07-01 false Sheltered workshops. 60... INDIVIDUALS WITH DISABILITIES Affirmative Action Program § 60-741.45 Sheltered workshops. Contracts with...
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41 CFR 60-741.45 - Sheltered workshops.
Code of Federal Regulations, 2012 CFR
2012-07-01
... within an affirmative action program if the sheltered workshop trains employees for the contractor and... 41 Public Contracts and Property Management 1 2012-07-01 2009-07-01 true Sheltered workshops. 60... INDIVIDUALS WITH DISABILITIES Affirmative Action Program § 60-741.45 Sheltered workshops. Contracts with...
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Kepler Mission IYA Teacher Professional Development Workshops
NASA Astrophysics Data System (ADS)
Devore, E. K.; Harman, P.; Gould, A. D.; Koch, D.
2009-12-01
NASA's Kepler Mission conducted six teacher professional development workshops on the search for Earth-size in the habitable zone of Sun-like stars. The Kepler Mission launched in March, 2009. As a part of International Year of Astronomy 2009, this series of one-day workshops were designed and presented for middle and high school teachers, and science center and planetarium educators prior to and after the launch. The professional development workshops were designed using the best practices and principals from the National Science Education Standards and similar documents. Sharing the outcome of our plans, strategies and formative evaluation results can be of use to other Education and Public Outreach practitioners who plan similar trainings. Each event was supported by a Kepler team scientist, two Education & Public Outreach staff and local hosts. The workshops combined a science content lecture and discussion, making models, kinesthetic activities, and interpretation of transit data. The emphasis was on inquiry-based instruction and supported science education standards in grades 7-12. Participants’ kit included an orrery, optical sensor and software to demonstrate transit detection. The workshop plan, teaching strategies, and lessons learned from evaluation will be discussed. Future events are planned. Kepler's Education and Public Outreach program is jointly conducted by the SETI Institute and Lawrence Hall of Science at UC Berkeley in close coordination with the Kepler Mission at NASA Ames Research Center. The IYA Kepler Teacher Professional Development workshops were supported by NASA Grants to the E. DeVore, SETI Institute NAG2-6066 Kepler Education and Public Outreach and NNX08BA74G, IYA Kepler Mission Pre-launch Workshops. Teachers participate in human orrery.
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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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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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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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Stone, Benjamin V; Forde, James C; Levit, Valerie B; Lee, Richard K; Te, Alexis E; Chughtai, Bilal
2016-11-01
In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. Google Trends™ was utilized to evaluate search engine trends for the term "pelvic organ prolapse" and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term "pelvic organ prolapse." The search results for the term "pelvic organ prolapse" were assessed for quality using the Health On the Net Foundation (HON) certification. There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r 2 = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information. Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.
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Seife, Charles
2015-04-01
Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature. To identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature. Cross-sectional analysis of publicly available documents, dated from January 1, 1998, to September 30, 2013, describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found. For each inspection document that could be linked to a specific published clinical trial, the main measure was a yes/no determination of whether there was mention in the peer-reviewed literature of problems the FDA had identified. Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published. When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.
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Zineh, Issam; Pacanowski, Michael A
2011-08-01
Pharmacogenomics is the study of how genetic variations influence responses to drugs, diagnostics, or biologic agents. The field of pharmacogenomics has significant potential to enhance drug development and aid in making regulatory decisions. The United States Food and Drug Administration (FDA) has supported pharmacogenomics for nearly a decade by providing regulatory advice and reviewing applications, with the intent of discovering and applying genetic determinants of treatment effects. The FDA will continue to develop policies and processes centered on genomics and individualized therapeutics to guide rational drug development. It will also continue to inform the public of clinically relevant pharmacogenomic issues through various mechanisms of communication, such as drug labeling. In this review, we provide a perspective on several pharmacogenomic activities at the FDA. In addition, we attempt to clarify what we believe are several misperceptions regarding the FDA's pharmacogenomic initiatives. We hope this perspective provides a window into some ways in which the FDA is enabling individualized therapeutics through its mission-critical activities.
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Summaries of the Third Annual JPL Airborne Geoscience Workshop. Volume 2: TIMS Workshop
NASA Technical Reports Server (NTRS)
Realmuto, Vincent J. (Editor)
1992-01-01
This publication contains the preliminary agenda and summaries for the Third Annual JPL Airborne Geoscience Workshop, held at the Jet Propulsion Laboratory, Pasadena, California, on 1-5 June 1992. This main workshop is divided into three smaller workshops as follows: (1) the Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on June 1 and 2; the summaries for this workshop appear in Volume 1; (2) the Thermal Infrared Multispectral Scanner (TIMS) workshop, on June 3; the summaries for this workshop appear in Volume 2; and (3) the Airborne Synthetic Aperture Radar (AIRSAR) workshop, on June 4 and 5; the summaries for this workshop appear in Volume 3.
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Summaries of the Third Annual JPL Airborne Geoscience Workshop. Volume 3: AIRSAR Workshop
NASA Technical Reports Server (NTRS)
Vanzyl, Jakob (Editor)
1992-01-01
This publication contains the preliminary agenda and summaries for the Third Annual JPL Airborne Geoscience Workshop, held at the Jet Propulsion Laboratory, Pasadena, California, on 1-5 June 1992. This main workshop is divided into three smaller workshops as follows: (1) the Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on June 1 and 2; the summaries for this workshop appear in Volume 1; (2) the Thermal Infrared Multispectral Scanner (TIMS) workshop, on June 3; the summaries for this workshop appear in Volume 2; and (3) the Airborne Synthetic Aperture Radar (AIRSAR) workshop, on June 4 and 5; the summaries for this workshop appear in Volume 3.
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Summaries of the Fifth Annual JPL Airborne Earth Science Workshop. Volume 3: AIRSAR Workshop
NASA Technical Reports Server (NTRS)
Vanzyl, Jakob (Editor)
1995-01-01
This publication is the third containing summaries for the Fifth Annual JPL Airborne Earth Science Workshop, held in Pasadena, California, on January 23-26, 1995. The main workshop is divided into three smaller workshops as follows: (1) The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on January 23-24. The summaries for this workshop appear in Volume 1; (2) The Airborne synthetic Aperture Radar (AIRSAR) workshop, on January 25-26. The summaries for this workshop appear in this volume; and (3) The Thermal Infrared Multispectral Scanner (TIMS) workshop, on January 26. The summaries for this workshop appear in Volume 2.
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Summaries of the Fifth Annual JPL Airborne Earth Science Workshop. Volume 1: AVIRIS Workshop
NASA Technical Reports Server (NTRS)
Green, Robert O. (Editor)
1995-01-01
This publication is the first of three containing summaries for the Fifth Annual JPL Airborne Earth Science Workshop, held in Pasadena, California, on January 23-26, 1995. The main workshop is divided into three smaller workshops as follows: (1) The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on January 23-24. The summaries for this workshop appear in this volume; (2) The Airborne Synthetic Aperture Radar (AIRSAR) workshop, on January 25-26. The summaries for this workshop appear in Volume 3; and (3) The Thermal Infrared Multispectral Scanner (TIMS) workshop, on January 26. The summaries for this workshop appear in Volume 2.
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Summaries of the 4th Annual JPL Airborne Geoscience Workshop. Volume 2: TIMS Workshop
NASA Technical Reports Server (NTRS)
Realmuto, Vincent J. (Editor)
1993-01-01
This is volume 2 of a three volume set of publications that contain the summaries for the Fourth Annual JPL Airborne Geoscience Workshop, held in Washington, D.C. on October 25-29, 1993. The main workshop is divided into three smaller workshops as follows: The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on October 25-26. The summaries for this workshop appear in Volume 1. The Thermal Infrared Multispectral Scanner (TIMS) workshop, on October 27. The summaries for this workshop appear in Volume 2. The Airborne Synthetic Aperture Radar (AIRSAR) workshop, on October 28-29. The summaries for this workshop appear in Volume 3.
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Summaries of the Fifth Annual JPL Airborne Earth Science Workshop. Volume 2: TIMS Workshop
NASA Technical Reports Server (NTRS)
Realmuto, Vincent J. (Editor)
1995-01-01
This publication is the second volume of the summaries for the Fifth Annual JPL Airborne Earth Science Workshop, held in Pasadena, California, on January 23-26, 1995. The main workshop is divided into three smaller workshops as follows: (1) The Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop on January 23-24. The summaries for this workshop appear in Volume 1; (2) The Airborne Synthetic Aperture Radar (AIRSAR) workshop on January 25-26. The summaries for this workshop appear in volume 3; and (3) The Thermal Infrared Multispectral Scanner (TIMS) workshop on January 26. The summaries for this workshop appear in this volume.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-30
... Diseases; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public hearing... with rare diseases, a recent public law (Agriculture, Rural Development, Food and Drug Administration...
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Biomedical applications of tissue engineering technology: regulatory issues.
Hellman, K B
1995-01-01
Novel emerging technologies such as tissue engineering, which utilize the approaches of molecular and cell biology, biotechnology, as well as materials science and engineering, are being used in the development of a wide range of biomedical products developed by industries regulated by the U.S. Food and Drug Administration (FDA). The FDA's mission is to promote and protect the public health by ensuring the safety and effectiveness of pharmaceuticals and medical devices, including those manufactured by novel technology, as assessed by scientific principles and methods. Regulatory review is conducted on a product-by-product basis. To accomplish its mission over the wide range of products in its regulatory purview, the FDA has six centers, each staffed with the scientific and regulatory expertise to evaluate the products in the center's jurisdiction. Recent legislative and regulatory changes are designed to simplify and facilitate the administrative process for evaluating novel combination products emanating from such interdisciplinary technology as tissue engineering and to resolve questions of product regulatory jurisdiction. Under the new procedures, the FDA may designate a lead FDA center for product review based on the primary mode of action of the combination product, with additional center(s) designated to assist in the evaluation in a collaborative or consultative capacity. In addition, FDA centers have increased their cooperation and information sharing with regard to evolving interdisciplinary technology. The FDA InterCenter Tissue Engineering Initiative was established to develop information on intercenter efforts in the evaluation of tissue engineering applications and to identify areas for further consideration. The FDA InterCenter Tissue Engineering Working Group, comprised of staff from the Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.
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75 FR 25281 - Food Protection Workshop; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-07
... establishments such as farms, manufacturers, processors, distributors, retailers, and restaurants. Date and Time... establishments (such as farms, manufacturers, processors, distributors, retailers, and restaurants) originating..., distributors, retailers, and restaurants) to better comply with any regulations authorized by the Public Health...
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Beijers, Lian; Jeronimus, Bertus F; Turner, Erick H; de Jonge, Peter; Roest, Annelieke M
2017-03-29
This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as 'non-FDA' concerns. Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.
Kowitt, Sarah D; Schmidt, Allison M; Hannan, Anika; Goldstein, Adam O
2017-01-01
Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125) and adults (N = 5,014), we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA) and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA). In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.
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Summaries of the Third Annual JPL Airborne Geoscience Workshop. Volume 1: AVIRIS Workshop
NASA Technical Reports Server (NTRS)
Green, Robert O. (Editor)
1992-01-01
This publication contains the preliminary agenda and summaries for the Third Annual JPL Airborne Geoscience Workshop, held at the Jet Propulsion Laboratory, Pasadena, California, on 1-5 June 1992. This main workshop is divided into three smaller workshops as follows: (1) the Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) workshop, on June 1 and 2; (2) the Thermal Infrared Multispectral Scanner (TIMS) workshop, on June 3; and (3) the Airborne Synthetic Aperture Radar (AIRSAR) workshop, on June 4 and 5. The summaries are contained in Volumes 1, 2, and 3, respectively.
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Summaries of the 4th Annual JPL Airborne Geoscience Workshop. Volume 3: AIRSAR Workshop
NASA Technical Reports Server (NTRS)
Vanzyl, Jakob (Editor)
1993-01-01
This publication contains the summaries for the Fourth Annual JPL Airborne Geoscience Workshop, held in Washington, D.C. on October 25-29, 1993. The main workshop is divided into three smaller workshops as follows: The Airborne Visible/Infrared Spectrometer (AVIRIS) workshop, on October 25-26, whose summaries appear in Volume 1; The Thermal Infrared Multispectral Scanner (TIMS) workshop, on October 27, whose summaries appear in Volume 2; and The Airborne Synthetic Aperture Radar (AIRSAR) workshop, on October 28-29, whose summaries appear in this volume, Volume 3.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-18
... help FDA in developing an enforcement action plan. FDA is seeking input on a number of specific issues... generally and to reduce tobacco use by minors. Tobacco products are responsible for more than 440,000 deaths... other things, that the use of tobacco products by children is a pediatric disease and virtually all new...
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The history and contemporary challenges of the US Food and Drug Administration.
Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric
2007-01-01
The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.
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Natural resource workshop: Public/private partnership for sustainable use of natural resources
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-07-01
As part of an effort to shape Federal policy for environmentally sound, sustainable economic development, the White House Office of Science and Technology Policy sponsored a workshop in Boise, Idaho on February 1--2, 1995. The Boise Idaho workshop focused on the sustainable use of natural resources, a topic of considerable interest in Idaho. The workshop gave representatives from industry, academia, research, the public, and local and state government an opportunity to provide input to lawmakers and policymakers for establishing a National Environmental Technology Strategy to be issued by Earth Day, 1995.
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78 FR 66368 - National Institute of Mental Health; Notice of Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-05
... Health; Notice of Workshop Notice is hereby given of a workshop convened by the Interagency Autism... Plan for Autism Spectrum Disorder Research. The workshop will be open to the public and accessible by live webcast and conference call. Name of Committee: Interagency Autism Coordinating Committee (IACC...
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77 FR 2040 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-13
... workshop. The workshop topic is volunteer angler data collection. DATES: The meeting will be held on...: (302) 526-5255. SUPPLEMENTARY INFORMATION: The workshop will include briefings on established volunteer... volunteer angler data collections and their uses. This workshop is a product of the Marine Recreational...
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The Assessment and Management of Suicide Risk: State of Workshop Education
ERIC Educational Resources Information Center
Pisani, Anthony R.; Cross, Wendi F.; Gould, Madelyn S.
2011-01-01
A systematic search of popular and scholarly databases identified workshops that addressed general clinical competence in the assessment or management of suicide risk, targeted mental health professionals, and had at least one peer-reviewed publication. We surveyed workshop developers and examined empirical articles associated with each workshop.…
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Tong, Weida; Harris, Stephen C; Fang, Hong; Shi, Leming; Perkins, Roger; Goodsaid, Federico; Frueh, Felix W
2007-01-01
Pharmacogenomics (PGx) is identified in the FDA Critical Path document as a major opportunity for advancing medical product development and personalized medicine. An integrated bioinformatics infrastructure for use in FDA data review is crucial to realize the benefits of PGx for public health. We have developed an integrated bioinformatics tool, called ArrayTrack, for managing, analyzing and interpreting genomic and other biomarker data (e.g. proteomic and metabolomic data). ArrayTrack is a highly flexible and robust software platform, which allows evolving with technological advances and changing user needs. ArrayTrack is used in the routine review of genomic data submitted to the FDA; here, three hypothetical examples of its use in the Voluntary eXploratory Data Submission (VXDS) program are illustrated.: © Published by Elsevier Ltd.
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1999-05-14
The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.
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Gruber, Marion F
2011-07-01
Vaccines for prevention or treatment of infectious diseases are biological products that are regulated by the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research of the US FDA. The legal framework for the regulation of vaccines derives primarily from Section 351 of the Public Health Service Act and from certain sections of the Federal Food, Drug and Cosmetic Act (FFD & C Act). The FDA Amendments Act of 2007 (FDAAA 2007) includes extensive modifications to the FFD & C Act. This article provides an overview of the review process for preventive vaccines and highlights applicable statutory provisions. In addition, this article will discuss changes in the pre-and post-licensure evaluation process for preventive and therapeutic infectious disease vaccines since implementation of the FDAAA 2007.
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Wallach, Joshua D; Egilman, Alexander C; Dhruva, Sanket S; McCarthy, Margaret E; Miller, Jennifer E; Woloshin, Steven; Schwartz, Lisa M; Ross, Joseph S
2018-05-24
To characterize postmarketing requirements for new drugs and biologics approved by the US Food and Drug Administration (FDA), and to examine rates and timeliness of registration, results reporting, and publication of required prospective cohort studies, registries, and clinical trials. Cross sectional analysis. Postmarketing requirements for all new drugs and biologics approved by the FDA between 1 January 2009 and 31 December 2012, with follow-up up to 15 November 2017. Postmarketing requirements and their characteristics known at the time of FDA approval, including FDA authority, study design, and study characteristics. Rates and timeliness of registration and results reporting on ClinicalTrials.gov and publication in peer reviewed journals of required prospective cohort studies, registries, and clinical trials. Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one postmarketing requirement at the time of first approval, for a total of 437 postmarketing requirements. Postmarket study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) postmarketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies. Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomization, comparator type, allocation, outcome, and number of patients to be enrolled, respectively. Of 134 required prospective cohort studies, registries, and clinical trials, 102 (76.1%) were registered on ClinicalTrials.gov; of 50 registered and completed studies, 36 (72.0%) had reported results on ClinicalTrials.gov. Among 65 completed studies, 47 (72.3%) had either reported results or were published a median of 47 months (interquartile range 32-67) after FDA approval. 32 (68.1%) of these 47 studies did not report results publicly by the time of their original FDA report submission deadline. Postmarketing requirements for new drugs and biologics were often briefly described and did not contain enough information to characterize study designs. Approximately three quarters of postmarketing requirements for prospective cohort studies, registries, and clinical trials were registered on ClinicalTrials.gov, and nearly three quarters of completed studies reported results or were published, suggesting that at least a quarter of these required studies are not being publicly disseminated. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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First National Space Grant Conference report
NASA Technical Reports Server (NTRS)
1990-01-01
The main business of the conference centered around a series of 15 workshops in which 15 program directors of their designates discussed various components of the Space Grant Program. On the basis of the workshops and conference discussion, the workshop facilitators redrafted and edited the reports, and these reports are presented. The topics covered include: an evaluation of the NASA Space Grant Consortia Programs; pre-college and college education; the use of continuing adult education; publicity and public relations; underrepresented groups; outreach and public service; state and local governments; university-industry interaction; program management; and use of fellowships.
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Huang, Shiew-Mei; Strong, John M; Zhang, Lei; Reynolds, Kellie S; Nallani, Srikanth; Temple, Robert; Abraham, Sophia; Habet, Sayed Al; Baweja, Raman K; Burckart, Gilbert J; Chung, Sang; Colangelo, Philip; Frucht, David; Green, Martin D; Hepp, Paul; Karnaukhova, Elena; Ko, Hon-Sum; Lee, Jang-Ik; Marroum, Patrick J; Norden, Janet M; Qiu, Wei; Rahman, Atiqur; Sobel, Solomon; Stifano, Toni; Thummel, Kenneth; Wei, Xiao-Xiong; Yasuda, Sally; Zheng, Jenny H; Zhao, Hong; Lesko, Lawrence J
2008-06-01
Predicting clinically significant drug interactions during drug development is a challenge for the pharmaceutical industry and regulatory agencies. Since the publication of the US Food and Drug Administration's (FDA's) first in vitro and in vivo drug interaction guidance documents in 1997 and 1999, researchers and clinicians have gained a better understanding of drug interactions. This knowledge has enabled the FDA and the industry to progress and begin to overcome these challenges. The FDA has continued its efforts to evaluate methodologies to study drug interactions and communicate recommendations regarding the conduct of drug interaction studies, particularly for CYP-based and transporter-based drug interactions, to the pharmaceutical industry. A drug interaction Web site was established to document the FDA's current understanding of drug interactions (http://www.fda.gov/cder/drug/drugInteractions/default.htm). This report provides an overview of the evolution of the drug interaction guidances, includes a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document, Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling.
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Adverse drug events and the Freedom of Information Act: an apple in Eden.
Stang, P E; Fox, J L
1992-02-01
To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.
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Wood, Lauren N; Jamnagerwalla, Juzar; Markowitz, Melissa A; Thum, D Joseph; McCarty, Philip; Medendorp, Andrew R; Raz, Shlomo; Kim, Ja-Hong
2018-04-26
Uterine power morcellation, where the uterus is shred into smaller pieces, is a widely used technique for removal of uterine specimens in patients undergoing minimally invasive abdominal hysterectomy or myomectomy. Complications related to power morcellation of uterine specimens led to US Food and Drug Administration (FDA) communications in 2014 ultimately recommending against the use of power morcellation for women undergoing minimally invasive hysterectomy. Subsequently, practitioners drastically decreased the use of morcellation. We aimed to determine the effect of increased patient awareness on the decrease in use of the morcellator. Google Trends is a public tool that provides data on temporal patterns of search terms, and we correlated this data with the timing of the FDA communication. Weekly relative search volume (RSV) was obtained from Google Trends using the term “morcellation.” Higher RSV corresponds to increases in weekly search volume. Search volumes were divided into 3 groups: the 2 years prior to the FDA communication, a 1-year period following, and thereafter, with the distribution of the weekly RSV over the 3 periods tested using 1-way analysis of variance. Additionally, we analyzed the total number of websites containing the term “morcellation” over this time. The mean RSV prior to the FDA communication was 12.0 (SD 15.8), with the RSV being 60.3 (SD 24.7) in the 1-year after and 19.3 (SD 5.2) thereafter (P<.001). The mean number of webpages containing the term “morcellation” in 2011 was 10,800, rising to 18,800 during 2014 and 36,200 in 2017. Google search activity about morcellation of uterine specimens increased significantly after the FDA communications. This trend indicates an increased public awareness regarding morcellation and its complications. More extensive preoperative counseling and alteration of surgical technique and clinician practice may be necessary. ©Lauren N Wood, Juzar Jamnagerwalla, Melissa A Markowitz, D Joseph Thum, Philip McCarty, Andrew R Medendorp, Shlomo Raz, Ja-Hong Kim. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 26.04.2018.
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Wiseman, Samuel R
2015-01-01
In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers and local food proponents. The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the "sustainable agriculture" or "small farm" movement), to three aspects of the FDA's proposed rules--involving manure application, on-farm packing activities, and exemptions for very small farms--to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here--exemptions for very small farms--the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations, and yet prevailed. This suggests that the high salience of locavore and "slow food" issues might have allowed relatively small, dispersed interests to overcome traditional obstacles to political organization, and that the sustainable agriculture movement has indeed become an effective political force.
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Lacasse, Jeffrey R
2005-01-01
In the United States, antidepressant medications are heavily promoted through direct-to-consumer advertising, which is regulated by the Food and Drug Administration (FDA). Advertisements for selective serotonin reuptake inhibitors frequently contain information inconsistent with the scientific evidence on the treatment of depression with antidepressants. The information presented serves to promote the use of antidepressants by biasing the public against nonpharmacological treatment of depression. While the FDA enforces regulations requiring fair and balanced presentation when comparing one medication to another, there appears to be no action taken against pharmaceutical companies that distort scientific evidence in order to disparage nonmedical approaches to depression.
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Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.
Light, Donald W; Lexchin, Joel; Darrow, Jonathan J
2013-01-01
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. © 2013 American Society of Law, Medicine & Ethics, Inc.
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78 FR 59336 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food Hygiene
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-26
... for Food Safety, USDA. ACTION: Notice of public meeting and request for comments. SUMMARY: The Office... Administration (FDA), U.S. Department of Health and Human Services (HHS), are sponsoring a public meeting on October 23, 2013. The objective of the public meeting is to provide information and receive public...
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Continuing Education Workshops in Bioinformatics Positively Impact Research and Careers
Brazas, Michelle D.; Ouellette, B. F. Francis
2016-01-01
Bioinformatics.ca has been hosting continuing education programs in introductory and advanced bioinformatics topics in Canada since 1999 and has trained more than 2,000 participants to date. These workshops have been adapted over the years to keep pace with advances in both science and technology as well as the changing landscape in available learning modalities and the bioinformatics training needs of our audience. Post-workshop surveys have been a mandatory component of each workshop and are used to ensure appropriate adjustments are made to workshops to maximize learning. However, neither bioinformatics.ca nor others offering similar training programs have explored the long-term impact of bioinformatics continuing education training. Bioinformatics.ca recently initiated a look back on the impact its workshops have had on the career trajectories, research outcomes, publications, and collaborations of its participants. Using an anonymous online survey, bioinformatics.ca analyzed responses from those surveyed and discovered its workshops have had a positive impact on collaborations, research, publications, and career progression. PMID:27281025
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Continuing Education Workshops in Bioinformatics Positively Impact Research and Careers.
Brazas, Michelle D; Ouellette, B F Francis
2016-06-01
Bioinformatics.ca has been hosting continuing education programs in introductory and advanced bioinformatics topics in Canada since 1999 and has trained more than 2,000 participants to date. These workshops have been adapted over the years to keep pace with advances in both science and technology as well as the changing landscape in available learning modalities and the bioinformatics training needs of our audience. Post-workshop surveys have been a mandatory component of each workshop and are used to ensure appropriate adjustments are made to workshops to maximize learning. However, neither bioinformatics.ca nor others offering similar training programs have explored the long-term impact of bioinformatics continuing education training. Bioinformatics.ca recently initiated a look back on the impact its workshops have had on the career trajectories, research outcomes, publications, and collaborations of its participants. Using an anonymous online survey, bioinformatics.ca analyzed responses from those surveyed and discovered its workshops have had a positive impact on collaborations, research, publications, and career progression.
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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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Freeing Ourselves: Removing Internal Barriers to Equality. A Workshop for Women.
ERIC Educational Resources Information Center
Collier, Helen V.; And Others
This manual is for a developmental workshop for 12-18 women that uses didactic and experiential techniques to train participants to make freer educational and career choices. It contains four parts. Part 1, for the workshop administrator, overviews the nature of the workshop and provides information necessary for publicizing, organizing,…
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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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NIEHS/FDA CLARITY-BPA research program update.
Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T
2015-12-01
Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. Published by Elsevier Inc.
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NIEHS/FDA CLARITY-BPA research program update
Heindel, Jerrold J.; Newbold, Retha R.; Bucher, John R.; Camacho, Luísa; Delclos, K. Barry; Lewis, Sherry M.; Vanlandingham, Michelle; Churchwell, Mona I.; Twaddle, Nathan C.; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A.; Flaws, Jodi; Howard, Paul C.; Walker, Nigel J.; Zoeller, R. Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T.
2016-01-01
Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693
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Enhancing the incorporation of the patient's voice in drug development and evaluation.
Chalasani, Meghana; Vaidya, Pujita; Mullin, Theresa
2018-01-01
People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. FDA has conducted 24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings range from experiences common across rare diseases to more disease specific experiences that matter most to patients. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Patient-focused drug development is an ongoing effort and FDA looks forward to the next steps in advancing the science and the utilization of patient input throughout drug development and evaluation. The U.S. Food and Drug Administration (FDA) has multiple mechanisms for its regulators and staff to interact with patients -- but none quite like its novel Patient-Focused Drug Development (PFDD) initiative. FDA established the PFDD initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. Since the initiative's inception in 2012, FDA has held 24 PFDD meetings, covering a range of disease areas and hearing directly from thousands of patients and caregivers. FDA's PFDD meetings have also provided key stakeholders, including patient advocates, researchers, drug developers, healthcare providers, and other government officials, an opportunity to hear the patient's voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Further enhancing the incorporation of the patient's voice in drug development and evaluation continues to be a priority for FDA.
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76 FR 67461 - Cosmetic Microbiological Safety Issues; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0770] Cosmetic Microbiological Safety Issues; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments and opening of a docket. SUMMARY: The Food and Drug...
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Public key infrastructure for DOE security research
DOE Office of Scientific and Technical Information (OSTI.GOV)
Aiken, R.; Foster, I.; Johnston, W.E.
This document summarizes the Department of Energy`s Second Joint Energy Research/Defence Programs Security Research Workshop. The workshop, built on the results of the first Joint Workshop which reviewed security requirements represented in a range of mission-critical ER and DP applications, discussed commonalties and differences in ER/DP requirements and approaches, and identified an integrated common set of security research priorities. One significant conclusion of the first workshop was that progress in a broad spectrum of DOE-relevant security problems and applications could best be addressed through public-key cryptography based systems, and therefore depended upon the existence of a robust, broadly deployed public-keymore » infrastructure. Hence, public-key infrastructure ({open_quotes}PKI{close_quotes}) was adopted as a primary focus for the second workshop. The Second Joint Workshop covered a range of DOE security research and deployment efforts, as well as summaries of the state of the art in various areas relating to public-key technologies. Key findings were that a broad range of DOE applications can benefit from security architectures and technologies built on a robust, flexible, widely deployed public-key infrastructure; that there exists a collection of specific requirements for missing or undeveloped PKI functionality, together with a preliminary assessment of how these requirements can be met; that, while commercial developments can be expected to provide many relevant security technologies, there are important capabilities that commercial developments will not address, due to the unique scale, performance, diversity, distributed nature, and sensitivity of DOE applications; that DOE should encourage and support research activities intended to increase understanding of security technology requirements, and to develop critical components not forthcoming from other sources in a timely manner.« less
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NASA Astrophysics Data System (ADS)
Weller, N.; Bennett, I.; Bernstein, M.; Farooque, M.; Lloyd, J.; Lowenthal, C.; Sittenfeld, D.
2016-12-01
Actionable science seeks to align scientific inquiry with decision-making priorities to overcome rifts between scientific knowledge and the needs of decision makers. Combining actionable science with explorations of public values and priorities creates useful support for decision makers facing uncertainty, tradeoffs, and limited resources. As part of a broader project to create public forums about climate change resilience, we convened workshops with decision makers, resilience experts, and community stakeholders to discuss climate change resilience. Our goals were 1) to create case studies of resilience strategies for use in public deliberations at science museums across 8 U.S. cities; and 2) to build relationships with decision makers and stakeholders interested in these public deliberations. Prior to workshops, we created summaries of resilience strategies using academic literature, government assessments, municipal resilience plans, and conversations with workshop participants. Workshops began with example deliberation activities followed by semi-structured discussions of resilience strategies centered on 4 questions: 1) What are the key decisions to be made regarding each strategy? 2) What stakeholders and perspectives are relevant to each strategy? 3) What available data are relevant to each strategy? 4) What visualizations or other resources are useful for communicating things about each strategy? Workshops yielded actionable dialogue regarding issues of justice, feasibility, and the socio-ecological-technical systems impacted by climate change hazards and resilience strategies. For example, discussions of drought revealed systemic and individual-level challenges and opportunities; discussions of sea level rise included ways to account for the cultural significance of many coastal communities. The workshops provide a model for identifying decision-making priorities and tradeoffs and building partnerships among stakeholders, scientists, and decision makers.
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Gostin, L O; Arno, P S; Brandt, A M
1997-02-05
Perspectives on tobacco control in American society have shifted markedly. As the view that smoking as a voluntarily assumed health risk has declined, the social and political environment has become more conducive to industry regulation. This transformation can be traced to the mounting evidence of the health risks of secondary smoke; the addictive quality of nicotine; the vulnerability and exploitation of young people; and industry knowledge of the harmful effects of tobacco. Regulation of tobacco advertising and promotions by the Food and Drug Administration (FDA) raises serious concerns about constitutional protection for commercial speech. However, the minimal informational value of tobacco advertising suggests that it should be afforded a low level of constitutional protection. The FDA regulations impose reasonable "time, place, and manner" restrictions, leave open alternative channels of communication, restrict messages that are harmful to the public health, do not restrict political speech, prevent misleading messages, and help deter the unlawful sale of tobacco products to minors. The regulations meet the traditional criteria for regulating commercial speech, in that the government's asserted interest is strong, the agency's regulations directly advance that interest, and the regulations are no more extensive than necessary. Thus, the judiciary should defend the FDA's historical social and legislative mission to protect the public health.
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The Future of Public Health Informatics: Alternative Scenarios and Recommended Strategies
Edmunds, Margo; Thorpe, Lorna; Sepulveda, Martin; Bezold, Clem; Ross, David A.
2014-01-01
Background: In October 2013, the Public Health Informatics Institute (PHII) and Institute for Alternative Futures (IAF) convened a multidisciplinary group of experts to evaluate forces shaping public health informatics (PHI) in the United States, with the aim of identifying upcoming challenges and opportunities. The PHI workshop was funded by the Robert Wood Johnson Foundation as part of its larger strategic planning process for public health and primary care. Workshop Context: During the two-day workshop, nine experts from the public and private sectors analyzed and discussed the implications of four scenarios regarding the United States economy, health care system, information technology (IT) sector, and their potential impacts on public health in the next 10 years, by 2023. Workshop participants considered the potential role of the public health sector in addressing population health challenges in each scenario, and then identified specific informatics goals and strategies needed for the sector to succeed in this role. Recommendations and Conclusion: Participants developed recommendations for the public health informatics field and for public health overall in the coming decade. These included the need to rely more heavily on intersectoral collaborations across public and private sectors, to improve data infrastructure and workforce capacity at all levels of the public health enterprise, to expand the evidence base regarding effectiveness of informatics-based public health initiatives, and to communicate strategically with elected officials and other key stakeholders regarding the potential for informatics-based solutions to have an impact on population health. PMID:25848630
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Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S.
2011-01-01
Background Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Methods and Findings Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1–14). Six “teaser” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Conclusions Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information. PMID:21858076
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Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S
2011-01-01
Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
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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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Jamnagerwalla, Juzar; Markowitz, Melissa A; Thum, D Joseph; McCarty, Philip; Medendorp, Andrew R; Raz, Shlomo; Kim, Ja-Hong
2018-01-01
Background Uterine power morcellation, where the uterus is shred into smaller pieces, is a widely used technique for removal of uterine specimens in patients undergoing minimally invasive abdominal hysterectomy or myomectomy. Complications related to power morcellation of uterine specimens led to US Food and Drug Administration (FDA) communications in 2014 ultimately recommending against the use of power morcellation for women undergoing minimally invasive hysterectomy. Subsequently, practitioners drastically decreased the use of morcellation. Objective We aimed to determine the effect of increased patient awareness on the decrease in use of the morcellator. Google Trends is a public tool that provides data on temporal patterns of search terms, and we correlated this data with the timing of the FDA communication. Methods Weekly relative search volume (RSV) was obtained from Google Trends using the term “morcellation.” Higher RSV corresponds to increases in weekly search volume. Search volumes were divided into 3 groups: the 2 years prior to the FDA communication, a 1-year period following, and thereafter, with the distribution of the weekly RSV over the 3 periods tested using 1-way analysis of variance. Additionally, we analyzed the total number of websites containing the term “morcellation” over this time. Results The mean RSV prior to the FDA communication was 12.0 (SD 15.8), with the RSV being 60.3 (SD 24.7) in the 1-year after and 19.3 (SD 5.2) thereafter (P<.001). The mean number of webpages containing the term “morcellation” in 2011 was 10,800, rising to 18,800 during 2014 and 36,200 in 2017. Conclusions Google search activity about morcellation of uterine specimens increased significantly after the FDA communications. This trend indicates an increased public awareness regarding morcellation and its complications. More extensive preoperative counseling and alteration of surgical technique and clinician practice may be necessary. PMID:29699965
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2011-09-23
On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Originally, Boostrix was licensed in 2005 for persons aged 10 through 18 years, but in 2008, FDA approved an expanded age indication for Boostrix to include persons aged 19 through 64 years. FDA has now expanded the age indication to include persons aged 65 years and older. Boostrix is now licensed for use in persons aged 10 years and older as a single-dose booster vaccination. This notice summarizes the indications for use of Boostrix. Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously. Publication of revised Tdap recommendations within the next year is anticipated.
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78 FR 63223 - Fibromyalgia Public Meeting on Patient-Focused Drug Development; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-N-2013-1041] Fibromyalgia Public Meeting on Patient-Focused Drug Development; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments; correction. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0084] Submission of Extended Digital Electrocardiogram Waveform Data; Notice of Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and...
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Postmarketing Surveillance for “Modified-Risk” Tobacco Products
2012-01-01
Introduction: The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have “modified-risk” for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of marketing. Method: A narrative review approach was taken. The author searched and integrated publicly accessible literature on tobacco product surveillance as well as drug and medical device postmarket activities currently performed by FDA. Results: FDA relies on active and passive methods for postmarket surveillance and can require specific studies and risk evaluation and mitigation strategies for certain products, including those with abuse liability. Past efforts at examining the individual and population effects of reduced harm tobacco products provide an example of integrating different data streams. Discussion: Postmarket surveillance can be viewed in terms of the Agent–Host–Vector–Environment model, and concepts from diffusion of innovations are relevant to understanding factors associated with the adoption of new products by the population. Given that active and passive surveillance approaches have different strengths and weaknesses, multiple approaches may be necessary to evaluate population-level effects. Assuring that required studies are properly conducted and reported and that data indicating significant public health harms are quickly recognized will be important going forward. Conclusions: The advent of broad regulatory authority over tobacco provides opportunities for policy evaluation research. The research community can provide FDA with the independent science it needs to evaluate the public health impact of novel tobacco products. PMID:21330282
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Lesperance, Ann M.; Olson, Jarrod; Godinez, Melanie A.
On March 10, 2010 the workshop titled Social Networking for Emergency Management and Public Safety was held in Seattle, WA. The objective of this workshop was to showcase ways social media networking technologies can be used to support emergency management and public safety operations. The workshop highlighted the current state of social networking and where this dynamic engagement is heading, demonstrated some of the more commonly used technologies, highlighted case studies on how these tools have been used in a variety of jurisdictions and engaged the private sector on how these tools might serve as a conduit for two waymore » communication between with the public sector to address regional recovery issues and decision making.« less
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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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The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.
Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida
2016-07-01
The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.
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Berlin, Robert J
2009-09-01
I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement. One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category. Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products. Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-30
... foodborne illness. FSIS, FDA, and CDC are collaborating to address the methodological and data challenges... regarding metrics and on current methods being used. Accordingly, the Agencies will hold two regional public...
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76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... use, existing scientific research data to determine pediatric effectiveness based on a similar course... research data, and C. The methods to overcome the pitfalls and data gaps, including statistical approaches... announcing a public workshop entitled ``Using Scientific Research Data to Support Pediatric Medical Device...
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76 FR 70420 - New England Fishery Management Council; Public Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-14
... United States Coast Guard will hold a Commercial Fishing Gear Stowage Workshop to consider actions... Fisheries Training Center, 5200 East Hospital Road, Buzzards Bay, MA 02542. The public must preregister for this workshop to facilitate entrance to this secure facility, see supplementary information for details...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-30
... Quantitative Risk Assessment: Blood Safety and Availability; Public Workshops AGENCY: Food and Drug... and Transplantation Safety'' (EID public workshop) and ``Quantitative Risk Assessment: Blood Safety... Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, Suite 550N, Rockville, MD 20852-1448...
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Mitigation Strategies To Protect Food Against Intentional Adulteration. Final rule.
2016-05-27
The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).
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Teacher Professional Development: Lessons Learned from Six Kepler Mission Workshops
NASA Astrophysics Data System (ADS)
DeVore, Edna; Harman, P.; Gould, A.; Koch, D.
2010-01-01
NASA's Kepler Mission conducted teacher professional development workshops on the search for exoplanets in the habitable zone of Sun-like stars. During late 2008 and into 2009, six workshops were conducted surrounding the launch of the Kepler Mission. These were a part of the Kepler Mission's outreach honoring the International Year of Astronomy. Each workshop was supported by a Kepler team scientist, two Education & Public Outreach staff and local hosts. Activities combined a science content lecture and discussion, making models, kinesthetic activities, and interpretation of transit data. The emphasis was on inquiry-based instruction and supported science education standards in grades 7-12. Participants’ kit included an orrery, optical sensor and software to demonstrate transit detection. The workshop plan, teaching strategies, and lessons learned from evaluation will be discussed. The Kepler Mission teacher professional development workshops were designed using the best practices and principals from the National Science Education Standards and similar documents. Sharing the outcome of our plans, strategies and evaluation results can be of use to other Education and Public Outreach practitioners who plan similar events. In sharing our experiences, we hope to assist others, and to learn from them as well. Future events are planned. Supported by NASA Grants to the SETI Institute: NAG2-6066 Kepler Education and Public Outreach and NNX08BA74G, IYA Kepler Mission Pre-launch Workshops.
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75 FR 48179 - Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-09
...The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Ochs, R.
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-13
...) disposal facilities. The workshop has been developed to facilitate communication among Federal and State... and conceptual models, and (3) the selection of computer codes. Information gathered from invited.... NRC Public Meeting The purpose of this public meeting is to facilitate communication and gather...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-05
...] Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life...), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
... appropriate collection of data regarding the use, consumer perception, and health risks of an MRTP? III...] Scientific Evaluation of Modified Risk Tobacco Product Applications; Public Workshop; Request for Comments... obtain input on specific issues associated with the scientific evaluation of modified risk tobacco...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
... DEPARTMENT OF TRANSPORTATION Enabling a Secure Environment for Vehicle-to-Infrastructure Research Workshop; Notice of Public Meeting AGENCY: ITS Joint Program Office, Research and Innovative Technology Administration, U.S. Department of Transportation. ACTION: Notice. The U.S. Department of Transportation (USDOT...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-25
... hold a 1-day workshop on November 4, 2013. The workshop will be open to the public, with attendance limited to space available. DATES: The workshop will be held on November 4, 2013, from 8:00 a.m. to 3:30 p... entities. The November 4, 2013, workshop held by the KUHICC Urology Subcommittee, also called the ``Urology...
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Workshop on Molecular Animation
Bromberg, Sarina; Chiu, Wah; Ferrin, Thomas E.
2011-01-01
Summary February 25–26, 2010, in San Francisco, the Resource for Biocomputing, Visualization and Informatics (RBVI) and the National Center for Macromolecular Imaging (NCMI) hosted a molecular animation workshop for 21 structural biologists, molecular animators, and creators of molecular visualization software. Molecular animation aims to visualize scientific understanding of biomolecular processes and structures. The primary goal of the workshop was to identify the necessary tools for: producing high quality molecular animations, understanding complex molecular and cellular structures, creating publication supplementary materials and conference presentations, and teaching science to students and the public. Another use of molecular animation emerged in the workshop: helping to focus scientific inquiry about the motions of molecules and enhancing informal communication within and between laboratories. PMID:20947014
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77 FR 51814 - Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0882] Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-09
.... FDA-2013-N-0402] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public... public meeting that will provide an overview of the current status of the regulatory science initiatives... societies, and other interested stakeholders-- as it fulfills its statutory requirement under the Generic...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and... consumer interests on how to participate in the nomination and selection process for members representing...
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32 CFR 705.30 - Aerospace Education Workshop.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 32 National Defense 5 2011-07-01 2011-07-01 false Aerospace Education Workshop. 705.30 Section 705... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.30 Aerospace Education Workshop. (a) This... education programs. (b) Appropriate commands are encouraged to provide assistance to educational...
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76 FR 13984 - Cloud Computing Forum & Workshop III
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-15
... DEPARTMENT OF COMMERCE National Institute of Standards and Technology Cloud Computing Forum... public workshop. SUMMARY: NIST announces the Cloud Computing Forum & Workshop III to be held on April 7... provide information on the NIST strategic and tactical Cloud Computing program, including progress on the...
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Production Scheduling for Rehabilitation Workshops.
ERIC Educational Resources Information Center
Hietala, David A.
This publication examines production scheduling procedures for sheltered workshops. The manual includes three major sections: (1) the importance and benefits of production scheduling; (2) how-to information on performing basic scheduling in the workshop; and (3) answers to the question, What makes production scheduling work? The scheduling…
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32 CFR 705.30 - Aerospace Education Workshop.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 32 National Defense 5 2010-07-01 2010-07-01 false Aerospace Education Workshop. 705.30 Section 705... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.30 Aerospace Education Workshop. (a) This... education programs. (b) Appropriate commands are encouraged to provide assistance to educational...
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Value of Vintage Observatories and Historic Telescopes in Communicating Astronomy with the Public
NASA Astrophysics Data System (ADS)
Bell, T. E.
2010-10-01
The Antique Telescope Society convened a thematic workshop, The Vintage Observatory: Thriving in the 21st Century, on 2-4 May 2008. The workshop's purpose was to bring together those charged with the care of observatories and telescopes built before World War II, to examine common issues and share practical solutions, specifically in preparation for the International Year of Astronomy in 2009. Although much of the workshop concerned issues of preservation and restoration, several sessions focused on the uses of historical artefacts as a means for public education and outreach on astronomy and the history of astronomy, including discussion of the unique opportunities vintage observatories and telescopes offer in intriguing the public about astronomy.
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Brown, Kenneth H; McLachlan, Milla; Cardosa, Placido; Tchibindat, Félicité; Baker, Shawn K
2010-01-01
A three-day workshop was convened in Dakar, Senegal, to provide participants from West African and international academic and research institutions, public health agencies, and donor organisations an opportunity to review current public health nutrition research and training capabilities in West Africa, assess needs for strengthening the regional institutional and workforce capacities, and discuss appropriate steps required to advance this agenda. The workshop included presentations of background papers, experiences of regional and international training programmes and small group discussions. Participants concluded that there is an urgent need to: (1) increase the throughput of public health nutrition training programmes, including undergraduate education, pre-service and in-service professional training, and higher education in public health nutrition and related research skills; and (2) enhance applied research capacity, to provide the evidence base necessary for nutrition program planning and evaluation. A Task Team was appointed to inform the regional Assembly of Health Ministers of the workshop conclusions and to develop political and financial support for a regional nutrition initiative to: (1) conduct advocacy and nutrition stewardship; (2) survey existing training programmes and assist with curriculum development; and (3) develop a plan for a regional applied research institute in Public Health Nutrition.
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Meeting the challenges of medical countermeasure development.
Maher, Carmen; Hu-Primmer, Jean; MacGill, Tracy; Courtney, Brooke; Borio, Luciana
2012-09-01
Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three-pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures - and the systems to deliver them - and the requisite support of all stakeholders, including national leadership. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.
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Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J
2014-08-01
The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
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Toys and confectionery--a legally hazardous combination?
Eldred, J S; Pape, S M
1998-01-01
"What kind of magic has Nestlé worked on FDA?" Many in the confectionery business were asking this very question after seeing the company introduce onto the market in July 1997 - without any immediate agency intervention - a chocolate product surrounding an inedible plastic sphere enclosing a toy, bearing the moniker Nestlé Magic(R). A spate of recent publicity 1 on the controversy engendered by the new product has focused public attention on a little-known provision of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically section 402(d)(1). Adding fuel to the proverbial regulatory fire was the Food and Drug Administration's (FDA's) signaling of a possible reversal of its long-standing policy prohibiting the marketing of combination "confectionery and toy" products that contain nonfunctional, nonnutritive objects. After the product was launched, FDA, in response to a petition filed by Nestlé USA, stated its intention to 1) issue a guidance document that would purport to sanction such products on an interim basis, and 2) promulgate a regulation setting safety standards for such products and thereby authorize their marketing. Although Nestlé subsequently announced its withdrawal of the product,2 questions remain about the applicable law and FDA's authority. This article critically examines the agency's authority to authorize marketing of such products through a regulation that addresses the criteria set forth in section 402(d)(1).
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367
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76 FR 72389 - Pacific Fishery Management Council; Public Meetings/Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-23
... hold an online webinar to review and critique its groundfish stock assessment process in 2011. The online Groundfish Stock Assessment Process Review Workshop webinar is open to the public. DATES: The..., 2011 and continue until 5 p.m. or as necessary to complete business for the day. ADDRESSES: To join the...
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The Science of Public Messages for Suicide Prevention: A Workshop Summary
ERIC Educational Resources Information Center
Chambers, David A.; Pearson, Jane L.; Lubell, Keri; Brandon, Susan; O'Brien, Kevin; Zinn, Janet
2005-01-01
There is minimal guidance for efforts to create effective public messages that increase awareness that suicide is preventable. To address this need, several agencies in the U.S. Department of Health and Human Services and the Annenberg Foundation convened a workshop consisting of suicide prevention advocates and persons with expertise in public…
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Public Policy, Science, and Environmental Risk. Brookings Dialogues on Public Policy.
ERIC Educational Resources Information Center
Panem, Sandra, Ed.
This workshop explored the complex issues involved in scientific measurement of environmental risk. Specific purposes were to articulate policy issues that concern the use of scientific data in environmental risk assessment and to contribute to the dialogue from which better policy might emerge. Viewpoints of workshop participants from the…
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The Energy Crisis in the Public Schools; Alternative Solutions.
ERIC Educational Resources Information Center
Grossbach, Wilmar; Shaffer, William
One hundred and eighty school personnel held a workshop with representatives of the petroleum, natural gas, and electrical power industries. The objectives of the workshop were (1) to provide participants with a common body of knowledge and a common understanding of the energy crisis and its implications for the public schools, (2) to delineate…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-15
... Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations; Public Workshop AGENCY: Food and... Methods to Multiplex Detection of Transfusion- Transmissible Agents and Blood Cell Antigens in Blood... and the use of these tests in blood donor screening and blood cell antigen typing. The public workshop...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-25
... the International Maritime Organization's Development of a Mandatory Code for Ships Operating in Polar... States Coast Guard will hold a public workshop in Washington, DC on topics related to the development of... Polar Code). Various safety topics will be discussed including design, equipment, and operational...
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Workshop on Europa's Icy Shell: Past, Present, and Future
NASA Technical Reports Server (NTRS)
2004-01-01
This volume contains abstracts that have been accepted for presentation at the workshop on Europa's Icy Shell: Past, Present, and Future, February 6-8,2004, Houston, Texas. Administration and publications support for this meeting were provided by the staff of the Publications and Program Services Department at the Lunar and Planetary Institute.
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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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76 FR 62373 - Notice of Public Meeting-Cloud Computing Forum & Workshop IV
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-07
...--Cloud Computing Forum & Workshop IV AGENCY: National Institute of Standards and Technology (NIST), Commerce. ACTION: Notice. SUMMARY: NIST announces the Cloud Computing Forum & Workshop IV to be held on... to help develop open standards in interoperability, portability and security in cloud computing. This...
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Workshop on Children and Domestic Abuse.
ERIC Educational Resources Information Center
National Academy of Sciences - National Research Council, Washington, DC. Board on Children, Youth, and Families.
This workshop coordinates with the publication of a volume of "The Future of Children." The goal of the workshop is to bring together researchers, policymakers, health providers, and law enforcement to review available research literature on children and domestic violence. Topics that were addressed include prevalence and effect of…
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A public workshop, organized by a Steering Committee of scientists from government, industry, universities, and research organizations, was held at the National Institute of Environmental Health Sciences (NIEHS) in September, 2010. The workshop explored the dose-response implicat...
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Proceedings of the 1981 Workshop on Rural Transportation on Indian Reservations, with Bibliography.
DOT National Transportation Integrated Search
1983-11-01
This is a final report on the proceedings of the Workshop on Rural Transportation on Indian Reservations. The workshop was held on August 17, 1981 as an adjunct to the Fifth National Conference on Rural Public Transportation. The purpose of the works...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-28
... certificate in order to fish with or renew their limited-access shark and limited-access swordfish permits... Atlantic Shark Identification Workshops and Protected Species Safe Handling, Release, and Identification... (NOAA), Commerce. ACTION: Notice of public workshops. SUMMARY: Free Atlantic Shark Identification...
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78 FR 23574 - Public Workshop on Marine Technology and Standards
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-19
... Technology and Standards AGENCY: Coast Guard, DHS. ACTION: Notice. SUMMARY: The American Society of... workshop on marine technology and standards in Arlington, VA. We originally published a notice regarding... Engineers/United States Coast Guard (ASME/USCG) Workshop on Marine Technology and Standards provides a...
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Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?
Connolly, Gregory N; Alpert, Hillel R
2014-01-01
Background Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of “Lights” descriptors or similar terms on tobacco products that convey messages of reduced risk. Manufacturers eliminated terms explicitly stated and substituted colour name descriptors corresponding to the banned terms. This paper examines whether the tobacco industry complied with or circumvented the law and potential FDA regulatory actions. Methods Philip Morris retailer manuals, manufacturers' annual reports filed with the Massachusetts Department of Public Health, a national public opinion survey, and market-wide cigarette sales data were examined. Results Manufacturers substituted “Gold” for “Light” and “Silver” for “Ultra-light” in the names of Marlboro sub-brands, and “Blue”, “Gold”, and “Silver” for banned descriptors in sub-brand names. Percent filter ventilation levels, used to generate the smoke yield ranges associated with “Lights” categories, appear to have been reassigned to the new colour brand name descriptors. Following the ban, 92% of smokers reported they could easily identify their usual brands, and 68% correctly named the package colour associated with their usual brand, while sales for “Lights” cigarettes remained unchanged. Conclusions Tobacco manufacturers appear to have evaded a critical element of the FSPTCA, the ban on misleading descriptors that convey reduced health risk messages. The FPSTCA provides regulatory mechanisms, including banning these products as adulterated (Section 902). Manufacturers could then apply for pre-market approval as new products and produce evidence for FDA evaluation and determination whether or not sales of these products are in the public health interest. PMID:23485704
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Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration.
Robb, Melissa A; Racoosin, Judith A; Worrall, Chris; Chapman, Summer; Coster, Trinka; Cunningham, Francesca E
2012-11-01
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.
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Communicating uncertainties about prescription drugs to the public: a national randomized trial.
Schwartz, Lisa M; Woloshin, Steven
2011-09-12
Many new drugs are aggressively promoted. The public may not realize that even with US Food and Drug Administration (FDA) approval, important uncertainties about the benefits and harms of these drugs remain. We assessed the US public's understanding of the meaning of FDA drug approval and tested how brief explanations communicating drug uncertainties affect consumer choices. We conducted an Internet-based randomized controlled trial using a national sample of US adults from a research panel of approximately 30,000 households. A total of 2944 participants were randomized to receive 1 of 3 explanations about a pair of cholesterol drugs (1 approved based only on a surrogate outcome [lower cholesterol] and 1 based on a patient outcome [reduced myocardial infarctions]). Participants were randomized a second time to receive 1 of 3 explanations about a pair of heartburn drugs (1 newly approved and 1 approved 8 years earlier). Controls received no explanation; the nondirective group received explanations (for the cholesterol drugs, surrogates do not always translate into patient outcomes; for the heartburn drugs, it takes time to establish the safety of new drugs); the directive group received explanations plus advice to "Ask for a drug shown to reduce heart attacks or ask for one with a longer track record." The primary outcomes were choice: the cholesterol drug reducing myocardial infarctions, and the older heartburn drug. Thirty-nine percent mistakenly believed that the FDA approves only "extremely effective" drugs; 25% mistakenly believed that the FDA approves only drugs without serious side effects. Explanations affected choices: 71% of those in the directive group, 71% in the nondirective group, and 59% of controls chose the cholesterol drug that reduced myocardial infarctions (absolute difference, 12% [95% confidence interval, 7%-18%] for each explanation vs control). For the heartburn drugs, 53% of the directive group, 53% of the nondirective group, and 34% of controls chose the older drug (absolute difference, 19% [95% confidence interval, 13%-24%] for each explanation vs control). A substantial proportion of the public mistakenly believes that the FDA approves only extremely effective drugs and drugs lacking serious side effects. Brief explanations highlighting uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices. Nondirective explanations worked as well as directive ones. clinicaltrials.gov Identifiers: NCT00950157, NCT00950131.
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Pawar, Rahul S; Grundel, Erich
2017-03-01
The multi-billion dollar dietary supplement industry is global in reach. The industry has been criticized for problems related to poor quality control, safety, misbranding, and adulteration. In this review, we describe how the US Food and Drug Administration (FDA) regulates dietary supplements within the framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the FD&C Act, gave the FDA the authority to promulgate Good Manufacturing Practices for dietary supplements and required that manufacturers provide the FDA information supporting a conclusion that the ingredients are reasonably expected to be safe if the dietary ingredients were not marketed in the USA before 15 October 1994. Recent amendments to the FD&C Act require that serious dietary-supplement-related adverse events be reported to the FDA and provide the agency with mandatory recall authority. We discuss the presence of naturally occurring (e.g. Ephedra, Citrus aurantium, Acacia) and synthetic (e.g. β-methylphenethylamines, methylsynephrine, α-ethyl-phenethylamine) biologically active phenethylamines (PEAs) in dietary supplements and of PEA drugs (e.g. clenbuterol, fenfluramine, sibutramine, lorcaserin) in weight-loss products. Regulatory actions against manufacturers of products labelled as dietary supplements that contain the aliphatic amines 1,3-dimethylamine and 1,3-dimethylbutylamine, and PEAs such as β-methylphenethylamine, aegeline, and Dendrobium illustrate the FDA's use of its authority under the FD&C Act to promote dietary supplement safety. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
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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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NASA Astrophysics Data System (ADS)
Jones, A. P.; Hsu, B. C.; Bleacher, L.; Shaner, A. J.
2014-12-01
The Lunar Workshops for Educators are a series of weeklong workshops for grade 6-9 science teachers focused on lunar science and exploration, sponsored by the Lunar Reconnaissance Orbiter (LRO). These workshops have been held across the country for the past five years, in places underserved with respect to NASA workshops and at LRO team member institutions. MarsFest is a planetary analog festival that has been held annually in Death Valley National Park since 2012, made possible with support from the Curiosity (primarily the Sample Analysis at Mars) Education and Public Outreach team, NASA's Ames Research Center, NASA's Goddard Space Flight Center, the SETI Institute, and Death Valley National Park. Both the Lunar Workshops for Educators and MarsFest rely strongly on scientist engagement for their success. In the Lunar Workshops, scientists and engineers give talks for workshop participants, support facility tours and field trips, and, where possible, have lunch with the teachers to interact with them in a less formal setting. Teachers have enthusiastically appreciated and benefited from all of these interactions, and the scientists and engineers also provide positive feedback about their involvement. In MarsFest, scientists and engineers give public presentations and take park visitors on field trips to planetary analog sites. The trips are led by scientists who do research at the field trip sites whenever possible. Surveys of festival participants indicate an appreciation for learning about scientific research being conducted in the park from the people involved in that research, and scientists and engineers report enjoying sharing their work with the public through this program. The key to effective scientist engagement in all of the workshops and festivals has been a close relationship and open communication between the scientists and engineers and the activity facilitators. I will provide more details about both of these programs, how scientists and engineers are involved in them, and offer suggestions for others who would like to engage scientists and engineers in similar activities.
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NASA Astrophysics Data System (ADS)
McBride, S.; Herbulock, D.
2015-12-01
Providing natural hazards scientists the opportunity to question and engage directly with journalists in a workshop setting proved effective at shifting scientists' attitudes on their role in media and public communication during natural disasters. Scientists surveyed after the encounter expressed a more responsive attitude to communicating during crises, increased willingness to support scientific peers' communication efforts and more realistic perspectives on journalists' needs and objectives. Geoscientists experienced unprecedented and intensive media and public scrutiny during the Canterbury, New Zealand earthquakes of 2010-2012. Following major quakes and aftershocks, there was a sustained high level of public demand for information and expert analysis of the underlying geological events and ongoing hazards and risks. Once the crisis ended, a period of reflection gave rise to understanding of the need for further media and communication training amongst natural hazards scientists. A workshop designed to explore scientists' attitudes to public communication during disasters and challenge their views on media, press offices and the expectations of the public was developed and implemented by the Science Media Centre, New Zealand and Massey University. This research was developed as an evaluation of this workshop. Quantitative analysis with some qualititive analysis were the methods used. Some findings include: a shift in how journalists were perceived by scientists after the workshop, largely influenced by perspectives shared during a panel where invited journalists reflected on their own experiences and answered questions from scientists. discussions on different spokespeople from different science institutions contributing to the public discussion showed a change in perception from a preference for one central spokesperson to increased support for a variety of perspectives from multiple scientists. This was influenced by insight provided by journalists during the workshop into the practical demands of media and the need for multiple voices in media coverage. changes in how they would manage media queries, as well as a shift from passive to responsive attitudes towards communicating in crises.
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ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials
Schwartz, Lisa M.; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A.
2016-01-01
Background Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. Purpose To validate results posted on ClinicalTrials.gov against publicly-available FDA reviews on Drugs@FDA. Data sources ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical/statistical reviews). Study selection 100 parallel-group, randomized trials for new drug approvals (1/2013 – 7/2014) with results posted on ClinicalTrials.gov (3/15/2015). Data extraction Two assessors systematically extracted, and another verified, trial design, primary/secondary outcomes, adverse events, and deaths. Results The 100 trials were mostly phase 3 (90%) double-blind (92%), placebo-controlled (73%), representing 32 drugs from 24 companies. Of 137 primary outcomes from ClinicalTrials.gov, 134 (98%) had corresponding data in Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results; most differences were nominal (i.e. relative difference < 10%). Of 100 trials, primary outcome results in 14 could not be validated . Of 1,927 secondary outcomes from ClinicalTrials.gov, 1,061 (55%) definitions could be validated and 367 (19%) had results. Of 96 trials with ≥ 1 serious adverse event in either source, 14 could be compared and 7 were discordant. Of 62 trials with ≥ 1 death in either source, 25 could be compared and 17 were discordant. Limitations Unknown generalizability to uncontrolled or crossover trial results. Conclusion Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half of secondary outcomes could not be validated because Drugs@FDA only includes “key outcomes” for regulatory decision-making; nor could serious adverse events and deaths because Drugs@FDA frequently only includes results aggregated across multiple trials. PMID:27294570
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Pinkerton, JoAnn V.; Pickar, James H.
2016-01-01
Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479
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Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B
2014-11-01
The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.
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Lee, Joseph G. L.; Ranney, Leah M.; Goldstein, Adam O.
2016-01-01
Importance: Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335 661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. Objective: To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Design: Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. Setting: All 50 states and the District of Columbia. Participants: Tobacco retailer inspections conducted by FDA (n = 33 543). Exposure(s) for Observational Studies: State cigarette tax, youth smoking prevalence, poverty, and tobacco production. Main Outcome(s) and Measure(s): State proportion of FDA warning letters issued for single cigarette violations. Results: There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Conclusions and Relevance: Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. PMID:25744967
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Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O
2016-02-01
Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. 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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Environmental Scanning Workshop (Lansing, Michigan, June 10-11, 1992).
ERIC Educational Resources Information Center
Morrison, James L.
This publication presents an environmental scanning workshop for administrators in higher education institutions to help them incorporate environmental scanning into their planning and anticipation of future events. In particular, the workshop shows how to establish and sustain a comprehensive environmental scanning system and how to use the…
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32 CFR 705.30 - Aerospace Education Workshop.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 32 National Defense 5 2012-07-01 2012-07-01 false Aerospace Education Workshop. 705.30 Section 705... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.30 Aerospace Education Workshop. (a) This... of Naval Operations has cognizance of all assistance provided by the Navy to all Aerospace Education...
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32 CFR 705.30 - Aerospace Education Workshop.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 32 National Defense 5 2014-07-01 2014-07-01 false Aerospace Education Workshop. 705.30 Section 705... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.30 Aerospace Education Workshop. (a) This... of Naval Operations has cognizance of all assistance provided by the Navy to all Aerospace Education...
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32 CFR 705.30 - Aerospace Education Workshop.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 32 National Defense 5 2013-07-01 2013-07-01 false Aerospace Education Workshop. 705.30 Section 705... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.30 Aerospace Education Workshop. (a) This... of Naval Operations has cognizance of all assistance provided by the Navy to all Aerospace Education...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-30
... Changes in Extreme Storm Statistics: State of Knowledge; Notice of Open Public Workshop AGENCY: National... .) SUPPLEMENTARY INFORMATION: This workshop will provide an update to the climate science surrounding extreme... storms. Specific topics include: Severe Thunderstorms (and associated hail and winds), tornadoes, extreme...
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75 FR 67450 - Pipeline Safety: Control Room Management Implementation Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-02
... PHMSA-2010-0294] Pipeline Safety: Control Room Management Implementation Workshop AGENCY: Pipeline and...) on the implementation of pipeline control room management. The workshop is intended to foster an understanding of the Control Room Management Rule issued by PHMSA on December 3, 2009, and is open to the public...