Sample records for fda briefing document
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Hochhauser, Mark
2002-01-01
Healthcare costs are rising, mostly because of increased prescription drug use, chiefly as the result of direct-to-consumer drug ads on television, newspapers, and magazines. However, the FDA's requirement for a brief summary in direct-to-consumer drug ads has produced summaries that are ineffective because they are illegible and unreadable, create information overload, and require literacy skills not possessed by most consumers. If the FDA wants brief summaries to be in a patient-friendly format, it should provide document design templates and plain language examples. Unless brief summaries are written so that they can be understood by the average patient, they should be overhauled or done away with.
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Interpreting labels of abuse-deterrent opioid analgesics.
Webster, Lynn R
To provide an overview of available abuse-deterrent opioids (ADOs) and the labeling text that describes abuse-deterrent (AD) properties. A nonsystematic review of ADO literature and regulatory documents guiding their development. A critical assessment and discussion of common routes of opioid abuse, AD methods and properties, US Food and Drug Administration (FDA) study requirements to achieve AD labeling, and brief guide to understanding AD labels. The FDA has issued guidance as incentive and direction to industry to develop ADOs as one component of a multi-pronged public-health strategy to combat opioid abuse and misuse. The guidance describes separate categories of premarket and postmarket studies and makes recommendations for claims that may be made based on study findings. Ten ADOs have FDA-approved labeling attesting to AD properties. Available formulations that fail to conform to FDA guidance in study and labeling recommendations cannot be considered ADO. Formulations with AD properties are expected to reduce risk compared to the same agents without AD properties but cannot prevent all abuse and adverse clinical outcomes.
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Adams, Crystal
2016-02-18
The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented. In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.
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A review of the FDA draft guidance document for software validation: guidance for industry.
Keatley, K L
1999-01-01
A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document outlines validation considerations that the FDA regards as applicable to both medical device software and software used to "design, develop or manufacture" medical devices. The Draft Guidance is available at the FDA web site http:@www.fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry.
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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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ERIC Educational Resources Information Center
Food and Drug Administration (DHHS/PHS), Rockville, MD.
This document provides information, standards, and behavioral objectives for standardization and certification of retail food inspection personnel in the Food and Drug Administration (FDA). The procedures described in the document are based on the FDA Food Code, updated to reflect current Food Code provisions and to include a more refined focus on…
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2016-01-01
Background The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. Objective This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. Methods A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug’s risks and side effects or of a “major statement” identifying the drug’s major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of “fair balance,” the FDA’s requirement that prescription drug ads balance information relating to the drug’s risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Results Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug’s risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented. Conclusions In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads. PMID:26892749
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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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NASA Astrophysics Data System (ADS)
McMillan, Norman D.; O'Mongain, Eon; Walsh, James E.; Breen, Liam; McMillan, Duncan G.; Power, Michael J.; O'Dea, John P.; Kinsella, Seamus M.; Kelly, Mairead P.; Hammil, Conor; Orr, Dermot
1994-12-01
A preliminary investigation into the use of multiwavelength fiber drop analyzer (FDA) for the measurement of viscosity, spectral absorbance and refractive index is made with a view to obtaining conservative estimates of the instrumental capability of the FDA for these measurands. Some important new insights into drop vibrations are made from studies on the fiber drop traces (FDTs) of mechanically excited damped vibrations in drops with a set volume. A brief description of the feasibility measurements on the first application of the FDA in the diagnosis of disease in synovial fluid is given. Strong experimental evidence is reported for the existence of the surface-guided wave peak of the fiber drop trace and some new insights into the nature of the FDT are suggested based on a comparative study of the FDTs from a multiple-wavelength and a single-wavelength FDA. The earlier reported drop period dependence on applied electric field is critically reexamined, a new interpretation of this effect, is suggested, and an experimental study of clarification is given. Finally, a brief review of the projected capabilities of the FDA based on the work reported here is provided.
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75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-20
..., adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and... documents in a digital format, which FDA strongly encourages in order to improve the management and...
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Schroll, Jeppe Bennekou; Abdel-Sattar, Maher; Bero, Lisa
2015-01-01
To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports. This is a cross-sectional study. All new molecular drugs approved between January 1, 2011 and December 31, 2012 from the FDA and EMA Web sites were eligible. We included 27 drug reports. Most were searchable, but the FDA table of contents did not match the file's page numbers. Several FDA documents must be searched compared with a single EMA document, but the FDA reports contain more summary data on harms. Detailed information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All reports but one contained sufficient information to be used in a meta-analysis. Detailed data on efficacy and harms are available at the two agencies. The FDA has more summary data on harms, but the documents are harder to navigate. Published by Elsevier Inc.
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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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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FDA plan for statutory compliance. Notice of availability.
1998-11-24
The Food and Drug Administration (FDA) is announcing the availability of a document entitled "FDA Plan for Statutory Compliance" (the plan). This document is the agency's response to section 406(b) of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which requires the Secretary of the Department of Health and Human Services (the Secretary) to develop a plan bringing the agency into compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (the act).
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29 CFR 1987.108 - Role of Federal agencies.
Code of Federal Regulations, 2014 CFR
2014-07-01
... (CONTINUED) PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY...) The FDA, if interested in a proceeding, may participate as amicus curiae at any time in the proceeding, at the FDA's discretion. At the request of the FDA, copies of all documents in a case must be sent to...
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2007-02-01
The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
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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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75 FR 22812 - Guidance for Industry on Tobacco Health Document Submission; Availability; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0600] Guidance for Industry on Tobacco Health Document Submission; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-31
... information, including certain labeling information, to FDA for approval to market a product in interstate... and in a form that FDA can process, review, and archive. This requirement is in addition to the....12(b) in table 1 of this document. In July 1997, FDA revised Form FDA 356h ``Application to Market a...
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Annual update: drugs, diagnostics and devices.
Berardinelli, Candace; Kupecz, Deborah
2003-03-01
As NPs continue to play an important role in health care as administers of prescriptions, the value of reviewing the latest Food and Drug Administration (FDA) approvals for new drugs and devices is immeasurable. In 2002, the FDA approved several new drugs and devices, as well as monitored previously approved drugs for adverse reactions and untoward events. This article provides a brief review of relevant primary care topics.
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Problems caused by regulatory delays and lack of regulation
NASA Astrophysics Data System (ADS)
Reamer, Lynne A.
1994-12-01
An FDA perspective on some of the problems encountered during the device review process is described. Emphasis is placed on the need for communication and teamwork among all parties to make the system work. Manufacturers are encouraged to `Do it right the first time.' Pertinent questions are asked of the manufacturers and proposed solutions are presented. Day to day reality at FDA is described and document workload is revealed. Lack of regulation, or more appropriately, when less regulation is appropriate is discussed. FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device. This and other mechanisms are in place at the FDA to streamline the review process. Manufacturers are cautioned about their decisions and to seek advice from qualified persons. FDA emphasizes that help is available and that when in doubt, call.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-20
...The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA proposed these standards as part of our implementation of the FDA Food Safety Modernization Act. The document published with several technical errors, including some errors in cross references, as well as several errors in reference numbers cited throughout the document. This document corrects those errors. We are also placing a corrected copy of the proposed rule in the docket.
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Lucey, C
2006-11-01
This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-26
...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 1, 2011 (76 FR 45820). The document announced the fiscal year 2012 fee rates for certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections that are mandated in the FDA Food Safety Modernization Act (FSMA). The document was published with two typographical errors. This document corrects those errors.
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2002-01-14
The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.
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21 CFR 314.55 - Pediatric use information.
Code of Federal Regulations, 2010 CFR
2010-04-01
... group have failed. (4) FDA action on waiver. FDA shall grant a full or partial waiver, as appropriate... of disease, elimination or substantial reduction of a treatment-limiting drug reaction, documented...
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Standards for Lithotripter Performance
NASA Astrophysics Data System (ADS)
Schultheiss, Reiner; Doerffel, Michael
2008-09-01
Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-15
... on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards..., and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize... accessible at the Agency's Internet site. See section VI of this document for electronic access information...
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75 FR 20913 - Center for Devices and Radiological Health; New Address Information
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-22
... information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that... components of the agency's CDRH. The changes are the result of the relocation of these offices to FDA's White... with FDA Form 3500A. You may obtain the coding manual from CDRH's Web site at http://www.fda.gov/Safety...
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New obesity agents: lorcaserin and phentermine/topiramate.
Fleming, Joshua W; McClendon, Katie S; Riche, Daniel M
2013-01-01
To evaluate the evidence for lorcaserin and phentermine/topiramate in the treatment of obesity. Literature was accessed through PubMed (June 1975-March 2013) using the search terms lorcaserin, phentermine, topiramate, or phenter mine/topiramate. Additionally, reference citations from publications identified were reviewed. Additional information was obtained from the Food and Drug Administration (FDA)-approved prescribing information and FDA briefing documents. English-language articles focusing on Phase 3 clinical trials for obesity were critiqued. Data from preclinical and Phase 1 and/or 2 trials are reported when appropriate. Six prospective Phase 3 trials were reviewed. Obesity has reached epidemic proportions, affecting more than one third of adults in the US. Two medication products, lorcaserin and phenter mine/topiramate, have recently received FDA approval as adjuncts to a reduced-calorie diet and increased physical activity among individuals with a body mass index greater than or equal to 30 kg/m(2) or greater than or equal to 27 kg/m(2) with an obesity-related comorbidity, such as hypertension, dyslipidemia, or diabetes. Lorcaserin is a selective serotonin 5-HT2C agonist that regulates food intake, while the combination of phentermine/topiramate causes appetite suppression and enhanced satiety. Three Phase 3 randomized, placebo-controlled trials reported approximately 75% and 45% of patients achieved greater than or equal to 5% weight loss with phentermine/topiramate and lorcaserin, respectively. With lifestyle modification, phentermine/topiramate appears most effective in terms of weight loss. Lorcaserin demonstrates moderate efficacy. Long-term cardiovascular outcomes studies are needed to confirm the safety and benefit of these new obesity agents.
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2008-07-15
The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Heinzelman, K M; Mansfield, W G
This document evaluates the expected radiation dose due to the consumption of several specific food classes (dairy, meat, produce, etc.) contaminated with specific radionuclides, and relates concentration levels in food to the detection abilities of typical aboratory analysis/measurement methods. The attached charts present the limiting organ dose as a function of the radionuclide concentration in a particular food class, and allow the user to compare these concentrations and doses to typical analytical detection apabilities. The expected radiation dose depends on several factors: the age of the individual; the radionuclide present in the food; the concentration of the radionuclide in themore » food; and the amount of food consumed. Food consumption rates for individuals of various ges were taken from the 1998 United States Food and Drug Administration (FDA) document, Accidental Radioactive Contamination of HUman Food and Animal Feeds: Recommendations for State and Local Agencies. In that document, the FDA defines the erived Intervention Level (DIL), which is the concentration of a particular radionuclide in food that if consumed could result in an individual receiving a radiation dose exceeding the Protection Action Guide (PAG) thresholds for intervention. This document also resents odified, food class specific DIL, which is calculated using a somewhat modified version of the FDA's procedure. This document begins with an overview of the FDA's DIL calculation, followed by a description of the food class specific DIL calculations, and finally charts of the radiation dose per radioactivity concentration for several food class/radionuclide combinations.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-26
... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: August 20, 2013...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-13
... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: February 8, 2013...
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FDA regulation of adult stem cell therapies as used in sports medicine.
Chirba, Mary Ann; Sweetapple, Berkley; Hannon, Charles P; Anderson, John A
2015-02-01
In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
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2016-06-23
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
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2010-11-05
The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-16
... documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements...Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: April 10, 2013. Leslie Kux...
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How to Submit | Center for Cancer Research
be submitted by a current NIH or FDA fellow. The work does not need to have been done at the NIH/FDA. However, the submitter must be an author on the document and be in compliance with the intended journal's authorship guidelines or general good authorship practices.
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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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NASA Astrophysics Data System (ADS)
Bargo, Paulo R.; Jacques, Steven L.
2001-07-01
The FDA has approved PDT using Photofrin for certain esophageal and lung cancers, specifying an approved prescription of administered drug (mg/kg body weight) and administered light (J/linear cm of cylindrical fiber). This paper describes our development of a multi-optical fiber catheter for endoscopic use which documents the drug accumulated in the target tissues and the light penetration into the target tissues. The catheter uses reflectance to specify the light penetration depth and uses reflectance- corrected fluorescence to document drug accumulation. The goal is to document the variation in drug and light received by patients who are administered the FDA-approved prescription.
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Smischney, Nathan J; Onigkeit, James A; Hinds, Richard F; Nicholson, Wayne T
2015-01-01
U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Review of the 2011 and updated FDA guidance document on exemption from informed consent. The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.
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US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.
Lathrop, Julia Tait; Jeffery, Douglas A; Shea, Yvonne R; Scholl, Peter F; Chan, Maria M
2016-01-01
Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic. © 2015 American Association for Clinical Chemistry.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0492... Request; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...
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76 FR 49707 - CooperVision, Inc.; Filing of Color Additive Petitions
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463] CooperVision, Inc.; Filing of Color Additive Petitions Correction In proposed rule document 2011-16089 appearing on page 37690 in the issue of Tuesday, June 28, 2011...
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76 FR 66309 - Pilot Program for Parallel Review of Medical Products; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-3180-N2] Food and Drug Administration [Docket No. FDA-2010-N-0308] Pilot Program for Parallel Review of Medical... technologies to participate in a program of parallel FDA-CMS review. The document was published with an...
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21 CFR 316.50 - Guidance documents.
Code of Federal Regulations, 2010 CFR
2010-04-01
... USE ORPHAN DRUGS Availability of Information § 316.50 Guidance documents. FDA's Office of Orphan... the regulations in this part. The list is maintained on the Internet and is published annually in the...
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Patient-Focused Drug Development: A New Direction for Collaboration.
Perfetto, Eleanor M; Burke, Laurie; Oehrlein, Elisabeth M; Epstein, Robert S
2015-01-01
Patient-Focused Drug Development (PFDD) is a new initiative from the Food and Drug Administration (FDA) intended to bring patient perspectives into an earlier stage of product development. The goal is that patients will be able to provide context for benefit-risk assessments and input to review divisions, and also aid in the development of new assessment tools, study endpoints, and risk communications. This paper provides a summary on what is known to date about FDA's PFDD initiative and describes implications for patients, researchers, payers, and the biopharmaceutical industry. It also provides a roadmap for stakeholders to consider in defining their role in and in shaping PFDD's direction, and for expanding PFDD principles to conditions beyond the current 20 under FDA consideration. A search was conducted of the peer-reviewed and gray literature using PubMed and Google. This included laws, FDA guidance documents, the peer-reviewed literature, and FDA presentations for content relevant to the search term "patient-focused drug development." Currently, FDA activities within PFDD are limited to gaining patient insights through 20 disease-specific meetings. However, many stakeholders see the initiative much more generally as representing a broad shift toward patient centeredness in biopharmaceutical product development. Depending upon the trajectory taken and whether or not all PFDD aims are eventually addressed, the initiative has the potential to change product development in fundamental ways. Further research should explore how patient input on disease manifestation and treatment options is best ascertained from patients and documented before initiating and during drug development.
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21 CFR 10.115 - Good guidance practices.
Code of Federal Regulations, 2013 CFR
2013-04-01
..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...
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21 CFR 10.115 - Good guidance practices.
Code of Federal Regulations, 2014 CFR
2014-04-01
..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...
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21 CFR 10.115 - Good guidance practices.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...
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21 CFR 10.115 - Good guidance practices.
Code of Federal Regulations, 2012 CFR
2012-04-01
..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...
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76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-06
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.
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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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Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.
1985-10-22
The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-14
... Communication Research will design and administer the study. The proposed study will assess consumers' emotional... will help FDA to design more effective consumer food recall messages during and after a recall. FDA... collection of information is 354 hours (table 1 of this document). To help design and refine the...
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76 FR 55321 - CooperVision, Inc.; Filing of Color Additive Petitions
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463] CooperVision, Inc.; Filing of Color Additive Petitions Correction In proposed rule document C1-2011-16089 appearing on page 49707 in the issue of Thursday, August 11...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-03
... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-10
.... FDA-2012-F-0178] Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients; Correction... Administration (FDA) is correcting a document amending the regulations for irradiation of animal feed and pet...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-26
.../DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , or http...
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2006-05-26
On September 29, 2005, a human tissue-processing company discovered inaccuracies in donor records forwarded from a tissue-recovery firm and notified the Food and Drug Administration (FDA). An FDA investigation determined that the recovery firm, Biomedical Tissue Services, Ltd. (BTS) (Fort Lee, New Jersey), recovered tissues from human donors who might not have met donor eligibility requirements and who were not screened properly for certain infectious diseases. In October 2005, BTS and the five processors that had received the tissues, working with FDA, issued a recall for all tissues recovered by BTS. The continuing FDA investigation determined that information for some donors (e.g., cause, place, or time of death) was not consistent with death certificate data obtained from the states where the deaths occurred. The investigation also determined that BTS had failed to recover tissues in a manner that would prevent contamination or cross-contamination and failed to control environmental conditions adequately during tissue recovery. These failures were violations of the Current Good Tissue Practice Rules (effective May 25, 2005), which require manufacturers to recover, process, store, label, package, and distribute human cells, tissue, and cellular and tissue-based products (HCT/Ps) to prevent introduction, transmission, or spread of communicable diseases. In January 2006, FDA ordered BTS to cease manufacturing and to retain all HCT/Ps.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-14
... section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: May Nelson, Center for...-1717, May.Nelson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. E9-30657, appearing on page 68629...
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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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1986-02-19
The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Recommendations for Evaluation of Radiation Exposure from Diagnostic Radiology Examinations". The recommendations, prepared by FDA's Center for Devices and Radiological Health (CDRH), encourage diagnostic radiology facilities to take voluntary action to: Become aware of the radiation levels experienced by patients undergoing the projections commonly given in the facility; compare their radiation levels to generally accepted levels for these projections; and bring the exposures back into line if their levels fall consistently outside these generally accepted levels.
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Lindblad, Anne S; Manukyan, Zorayr; Purohit-Sheth, Tejashri; Gensler, Gary; Okwesili, Paul; Meeker-O'Connell, Ann; Ball, Leslie; Marler, John R
2014-04-01
Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification. To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections. An independent Analysis Center (AC) analyzed data from four anonymous new drug applications (NDAs) where FDA had performed site inspections overseen by FDA's Office of Scientific Investigations (OSI). FDA team members in the OSI chose the four NDAs from among all NDAs with data in Study Data Tabulation Model (SDTM) format. Two of the NDAs had data that OSI had deemed unreliable in support of the application after FDA site inspections identified serious data integrity problems. The other two NDAs had clinical data that OSI deemed reliable after site inspections. At the outset, the AC knew only that the experimental design specified two NDAs with significant problems. FDA gave the AC no information about which NDAs had problems, how many sites were inspected, or how many were found to have problems until after the AC analysis was complete. The AC evaluated randomization balance, enrollment patterns, study visit scheduling, variability of reported data, and last digit reference. The AC classified sites as 'High Concern', 'Moderate Concern', 'Mild Concern', or 'No Concern'. The AC correctly identified the two NDAs with data deemed unreliable by OSI. In addition, central data analysis correctly identified 5 of 6 (83%) sites for which FDA recommended rejection of data and 13 of 15 sites (87%) for which any regulatory deviations were identified during inspection. Of the six sites for which OSI reviewed inspections and found no deviations, the central process flagged four at the lowest level of concern, one at a moderate level, and one was not flagged. Central data monitoring during the conduct of a trial while data checking was in progress was not evaluated. Systematic central monitoring of clinical trial data can identify problems at the same trials and sites identified during FDA site inspections. Central data monitoring in conjunction with an overall monitoring process that adapts to identify risks as a trial progresses has the potential to reduce the frequency of site visits while increasing data integrity and decreasing trial costs compared to processes that are dependent primarily on source documentation.
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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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Brief Report: Metformin for Antipsychotic-Induced Weight Gain in Youth with Autism Spectrum Disorder
ERIC Educational Resources Information Center
Wink, Logan K.; Adams, Ryan; Pedapati, Ernest V.; Dominick, Kelli C.; Fox, Emma; Buck, Catherine; Erickson, Craig A.
2017-01-01
Antipsychotic treatment in youth with autism spectrum disorder (ASD) is becoming increasingly common, placing individuals at risk for antipsychotic-induced weight gain and associated complications. Metformin hydrochloride, a biguanide medication FDA-approved for treatment of type-2 diabetes in youth, may hold promise for treatment of…
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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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Atkinson, Thomas M; Mendoza, Tito R; Sit, Laura; Passik, Steven; Scher, Howard I; Cleeland, Charles; Basch, Ethan
2010-03-01
In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.
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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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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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2007-11-30
The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.
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Blankenship, Kelly; Erickson, Craig A; Stigler, Kimberly A; Posey, David J; McDougle, Christopher J
2011-01-01
Aripiprazole was recently US FDA-approved to treat irritability in children and adolescents with autistic disorder aged 6–17 years. There are currently only two psychotropics approved by the FDA to treat irritability in the autistic population. This drug profile will discuss available studies of aripiprazole in individuals with pervasive developmental disorders, two of which led to its recent FDA approval. We will discuss the efficacy, as well as the safety and tolerability of the drug documented in these studies. In addition, the chemistry, pharmacokinetics, metabolism and mechanism of action of aripiprazole will be reviewed. PMID:21359119
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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Williams, Emily C.; Rubinsky, Anna D.; Chavez, Laura J.; Lapham, Gwen T.; Rittmueller, Stacey E.; Achtmeyer, Carol E.; Bradley, Katharine A.
2014-01-01
Aims The US Veterans Health Administration [Veterans Affairs (VA)] used performance measures and electronic clinical reminders to implement brief intervention for unhealthy alcohol use. We evaluated whether documented brief intervention was associated with subsequent changes in drinking during early implementation. Design Observational, retrospective cohort study using secondary clinical and administrative data. Setting Thirty VA facilities. Participants Outpatients who screened positive for unhealthy alcohol use [Alcohol Use Disorders Identification Test Consumption (AUDIT-C ≥ 5)] in the 6 months after the brief intervention performance measure (n = 22 214) and had follow-up screening 9–15 months later (n = 6210; 28%). Measurements Multi-level logistic regression estimated the adjusted prevalence of resolution of unhealthy alcohol use (follow-up AUDIT-C <5 with ≥2 point reduction) for patients with and without documented brief intervention (documented advice to reduce or abstain from drinking). Findings Among 6210 patients with follow-up alcohol screening, 1751 (28%) had brief intervention and 2922 (47%) resolved unhealthy alcohol use at follow-up. Patients with documented brief intervention were older and more likely to have other substance use disorders, mental health conditions, poor health and more severe unhealthy alcohol use than those without (P-values < 0.05). Adjusted prevalences of resolution were 47% [95% confidence interval (CI) = 42–52%] and 48% (95% CI = 42–54%) for patients with and without documented brief intervention, respectively (P = 0.50). Conclusions During early implementation of brief intervention in the US Veterans Health Administration, documented brief intervention was not associated with subsequent changes in drinking among outpatients with unhealthy alcohol use and repeat alcohol screening. PMID:24773590
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Deficiencies in the reporting of VD and t1/2 in the FDA approved chemotherapy drug inserts
D’Souza, Malcolm J.; Alabed, Ghada J.
2011-01-01
Since its release in 2006, the US Food and Drug Administration (FDA) final improved format for prescription drug labeling has revamped the comprehensiveness of drug inserts, including chemotherapy drugs. The chemotherapy drug “packets”, retrieved via the FDA website and other accredited drug information reporting agencies such as the Physician Drug Reference (PDR), are practically the only available unbiased summary of information. One objective is to impartially evaluate the reporting of useful pharmacokinetic parameters, in particular, Volume of Distribution (VD) and elimination half-life (t1/2), in randomly selected FDA approved chemotherapy drug inserts. The web-accessible portable document format (PDF) files for 30 randomly selected chemotherapy drugs are subjected to detailed search and the two parameters of interest are tabulated. The knowledge of the two parameters is essential in directing patient care as well as for clinical research and since the completeness of the core FDA recommendations has been found deficient, a detailed explanation of the impact of such deficiencies is provided. PMID:21643531
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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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US Food and Drug Administration draft recommendations on radioactive contamination of food
DOE Office of Scientific and Technical Information (OSTI.GOV)
Thompson, D.L.
Recommendations on accidental radioactive contamination of human food were issued in 1982 by the Food and Drug Administration (FDA). The recommendations provided guidance to State and local government officials in the exercise of their respective authorities, and were applicable to emergency response planning and to the conduct of radiation protection activities associated with the production, processing, distribution, and use of human food accidentally contaminated with radioactive material. Review of the 1982 FDA recommendations, stimulated by the events following the 1986 accident at Chernobyl, indicated that it would be appropriate to update the recommendations to incorporate newer scientific information and radiationmore » protection philosophy, to include experience gained since 1982, and to take into account international advances. This paper presents a brief outline of the FDA`s approach to its draft revision. the most recent draft was circulated for interagency review in November 1994. Modification made in response to the comments received are included in this paper. 20 refs., 6 tabs.« less
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21 CFR 312.145 - Guidance documents.
Code of Federal Regulations, 2010 CFR
2010-04-01
... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... for a copy of the CDER list should be directed to the Office of Training and Communications, Division...
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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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2014-01-01
Background Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. Methods Five products approved for treatment of mCRPC by the FDA and the EMA (2010–2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. Results Nine PRO “claims” were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims—4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory–Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy–Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer–specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest for the BPI-SF worst pain item. Only the BPI-SF worst pain item has documented content validity in mCRPC. Conclusions PRO label claims were commonly granted across the mCRPC products reviewed. Among the measures reviewed, only the BPI-SF worst pain item supported US label claims. The BPI-SF worst pain item is recommended for pain assessment for the evaluation of new mCRPC treatments. PMID:24989428
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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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The nightmare of FDA clearance/approval to market: perception or reality?
Tylenda, C A
1996-09-01
Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.
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21 CFR 312.145 - Guidance documents.
Code of Federal Regulations, 2014 CFR
2014-04-01
... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...
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21 CFR 312.145 - Guidance documents.
Code of Federal Regulations, 2013 CFR
2013-04-01
... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...
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21 CFR 312.145 - Guidance documents.
Code of Federal Regulations, 2012 CFR
2012-04-01
... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...
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21 CFR 312.145 - Guidance documents.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-28
... Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug... for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow... announcing the availability of draft special controls guidance documents for 11 neurological and physical...
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Williams, Emily C.; Lapham, Gwen T.; Bobb, Jennifer F.; Rubinsky, Anna D.; Catz, Sheryl L.; Shortreed, Susan M.; Bensley, Kara M.; Bradley, Katharine A.
2017-01-01
Objective Unhealthy alcohol use is particularly risky for patients living with HIV (PLWH). Brief interventions reduce drinking among patients with unhealthy alcohol use, but whether its receipt in routine outpatient settings is associated with reduced drinking among PLWH with unhealthy alcohol use is unknown. We assessed whether PLWH who screened positive for unhealthy alcohol use were more likely to resolve unhealthy drinking one year later if they had brief alcohol intervention (BI) documented in their electronic health record in a national sample of PLWH from the Veterans Health Administration. Methods Secondary VA clinical and administrative data from the electronic medical record (EMR) were used to identify all positive alcohol screens (AUDIT-C score ≥ 5) documented among PLWH (10/01/09-5/30/13) followed by another alcohol screen documented 9–15 months later. Unadjusted and adjusted Poisson regression models assessed the association between brief intervention (advice to reduce drinking or abstain documented in EMR) and resolution of unhealthy alcohol use (follow-up AUDIT-C <5 with ≥ 2 point reduction). Results Overall 2,101 PLWH with unhealthy drinking (10/01/09-5/30/13) had repeat alcohol screens 9–15 months later. Of those, 77% had brief intervention documented after their first screen, and 61% resolved unhealthy alcohol use at follow-up. Documented brief intervention was not associated with resolution [Adjusted incidence rate ratio 0.96, (95% CI 0.90–1.02)]. Conclusions Documented brief intervention was not associated with resolving unhealthy alcohol use at follow-up screening among VA PLWH with unhealthy alcohol use. Effective methods of resolving unhealthy alcohol use in this vulnerable population are needed. PMID:28554608
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Biologics as countermeasures for acute radiation syndrome: where are we now?
Singh, Vijay K; Romaine, Patricia L P; Newman, Victoria L
2015-04-01
Despite significant scientific advances toward the development of a safe, nontoxic and effective radiation countermeasure for acute radiation syndrome (ARS) over the past six decades, no drug has been approved by the US FDA. Several biologics are currently under development as radiation countermeasures for ARS, of which three have received FDA Investigational New Drug (IND) status for clinical investigation. Presently, two of these agents, entolimod (CBLB502) and HemaMax (recombinant human IL-12) are progressing with large animal studies and clinical trials. Neupogen (G-CSF, filgrastim) has recently been recommended for approval by an FDA Advisory Committee. Filgrastim, GM-CSF (Leukine, sargramostim), and PEGylated G-CSF (Neulasta) have high potential and well-documented therapeutic effects in countering myelosuppression and may receive full licensing approval by the FDA in the future. The former two biologics are available in the US Strategic National Stockpile (SNS) for use in the event of nuclear or radiological emergency. The Emergency Use Authorization (EAU) application for entolimod may be filed soon with the FDA. Biologics are attractive agents that are progressing along the path for FDA approval, to fill the unmet need for ARS countermeasures.
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L-glutamine for sickle cell anemia: more questions than answers.
Quinn, Charles T
2018-06-12
In 2017, the Food and Drug Administration (FDA) approved two medications for sickle cell anemia (SCA): hydroxyurea for children (≥2 years of age) and L-glutamine for children and adults (≥5 years). The approval of hydroxyurea for children was long overdue, having been authorized by the FDA for adults in 1998 and by the European Medicines Agency for adults and children in 2007, but the approval of L-glutamine was a surprise to many in the field. There are few published studies of L-glutamine as a treatment for SCA, so all can be reviewed in this brief manuscript. Accordingly, there are many unanswered questions about L-glutamine and its role in current therapy for SCA. Copyright © 2018 American Society of Hematology.
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Regulatory Challenges for Cartilage Repair Technologies.
McGowan, Kevin B; Stiegman, Glenn
2013-01-01
In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.
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Regulatory Challenges for Cartilage Repair Technologies
Stiegman, Glenn
2013-01-01
In the United States, few Food and Drug Administration (FDA)–approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product’s attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible. PMID:26069647
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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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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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76 FR 16534 - New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-24
.... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction AGENCY: Food and...) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0724... not prepared at present to accept submissions utilizing this new version because eCTD software vendors need time to update their software to accommodate this information and because its use will require...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-08-01
This document provides a listing of Guidance Documents from the RCRA/CERCLA Division for August 1995. Documents are listed under the following categories: RCRA Guidance Manuals; RCRA Information Briefs; CERCLA Guidance Manuals; CERCLA Regulatory Bulletins; RCRA/CERCLA Guidance Manuals; TSCA Guidance Manuals; TSCA Information Briefs; and, Cross Cut Manuals.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-05
...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.
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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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2003-04-22
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
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Risk-Based Aviation Security: Diffusion and Acceptance
2012-03-01
Association ATR Automated Target Recognition BDO Behavior Detection Officer BIB Budget-In-Brief CBP Customs and Border Protection CDRH Center...Radiological Health ( CDRH ) (Cerra, 2006), the National Institute for Standards and Technology (NIST) (TSA, n.d. g), and the Johns Hopkins University Applied...safety related to AIT may have come from the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health ( CDRH ), the National
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The in vitro and in vivo genotoxicity of benzocaine: a brief communication.
Brock, William J; Bell, Thomas A
2012-06-01
Benzocaine has a long history of use in human medicine. However, benzocaine also has been used in aquaculture with finfish for more than 40 years for sedating fish for marking, transport, surgery, and so on, although benzocaine does not have a current Food and Drug Administration (FDA) approval for this application in the United States. As part of a FDA approval for use as an animal drug, the genotoxicity of benzocaine was evaluated in the in vitro bacterial reverse mutation assay and the forward mutation assay and in vivo in the mouse micronucleus assay. These studies were conducted in compliance with Good Laboratory Practice regulations and according to Veterinary International Conference on Harmonisation guidelines. Based on the results of these studies, benzocaine was determined not to be genotoxic.
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21 CFR 888.3080 - Intervertebral body fusion device.
Code of Federal Regulations, 2012 CFR
2012-04-01
... devices that contain bone grafting material. The special control is the FDA guidance document entitled... devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion...
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21 CFR 888.3080 - Intervertebral body fusion device.
Code of Federal Regulations, 2010 CFR
2010-04-01
... devices that contain bone grafting material. The special control is the FDA guidance document entitled... devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion...
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21 CFR 888.3080 - Intervertebral body fusion device.
Code of Federal Regulations, 2013 CFR
2013-04-01
... devices that contain bone grafting material. The special control is the FDA guidance document entitled... devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion...
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21 CFR 888.3080 - Intervertebral body fusion device.
Code of Federal Regulations, 2014 CFR
2014-04-01
... devices that contain bone grafting material. The special control is the FDA guidance document entitled... devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion...
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21 CFR 601.27 - Pediatric studies.
Code of Federal Regulations, 2010 CFR
2010-04-01
... action on waiver. FDA shall grant a full or partial waiver, as appropriate, if the agency finds that... treatment-limiting drug reaction; documented enhancement of compliance; or evidence of safety and...
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75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-20
...-847-8149 to receive a hard copy. Please use the document number (1607). CDRH maintains an entry on the... personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device... capability for all CDRH guidance documents is available at http://www.fda.gov/medicaldevices...
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21 CFR 314.445 - Guidance documents.
Code of Federal Regulations, 2014 CFR
2014-04-01
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...
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21 CFR 314.445 - Guidance documents.
Code of Federal Regulations, 2012 CFR
2012-04-01
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...
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21 CFR 314.445 - Guidance documents.
Code of Federal Regulations, 2011 CFR
2011-04-01
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...
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21 CFR 314.445 - Guidance documents.
Code of Federal Regulations, 2013 CFR
2013-04-01
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance...
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1998-09-25
The Food and Drug Administration (FDA) is proposing to amend 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 proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and it is intended to reduce the burden of unnecessary regulations on food, drugs, and cosmetics without diminishing the protection of the public health.
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Anti-Obesity Agents and the US Food and Drug Administration.
Casey, Martin F; Mechanick, Jeffrey I
2014-09-01
Despite the growing market for obesity care, the US Food and Drug Administration (FDA) has approved only two new pharmaceutical agents-lorcaserin and combination phentermine/topiramate-for weight reduction since 2000, while removing three agents from the market in the same time period. This article explores the FDA's history and role in the approval of anti-obesity medications within the context of a public health model of obesity. Through the review of obesity literature and FDA approval documents, we identified two major barriers preventing fair evaluation of anti-obesity agents including: (1) methodological pitfalls in clinical trials and (2) misaligned values in the assessment of anti-obesity agents. Specific recommendations include the use of adaptive (Bayesian) design protocols, value-based analyses of risks and benefits, and regulatory guidance based on a comprehensive, multi-platform obesity disease model. Positively addressing barriers in the FDA approval process of anti-obesity agents may have many beneficial effects within an obesity disease model.
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A roundtable discussion: home healthcare-not a hospital in the home.
Logan, Mary K; Parker, Chuck; Gardner-Bonneau, Daryle; Treu, Denny; Keller, James; Winstel, Lisa; Weick-Brady, Mary; Kramer, Nancy; Cyrus, Reginald; Thiel, Scott; Lewis, Vicki R; Rogers, Wendy
2013-01-01
Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-26
... of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to... notice announces the Web site location of the two lists of guidance documents which CDRH is intending to... list. FDA and CDRH priorities are subject to change at any time. Topics on this and past guidance...
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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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Inert Reassessment Document for n-Decyl Alcohol
Industrially, both alcohols are used as ingredients in perfumes, flavoring agents, and industrial solvents. In addition, the U s. S Food and Drug Administration (FDA) has approved the use of both chemicals as direct food additives.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro.... SUPPLEMENTARY INFORMATION: I. Background This draft guidance includes recommendations concerning 510(k...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-26
...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 28, 2011 (76 FR 37817). The document announced the availability of funds for the support of a sole source cooperative agreement with the World Health Organization. The document published stating that the total funding available was up to $260,000 (total costs including indirect costs) in fiscal year 2011 in support of this project. This document corrects that error.
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Inappropriate use of proton pump inhibitors in a local setting
Chia, Christopher Tze Wei; Lim, Wan Peng; Vu, Charles Kien Fong
2014-01-01
INTRODUCTION There are growing concerns that the use of proton pump inhibitors (PPIs) may be inappropriate in instances that do not conform to evidence-based indications. This point-prevalence study aimed to investigate the frequency, indications and appropriateness of use of PPIs in hospitalised patients on a randomly chosen day. METHODS On a randomly chosen day, all inpatients were documented, and those on any form of PPIs on that day were determined. Indications for maintaining these patients on PPIs were obtained from the electronic medical records, which were then recorded and cross-referenced against a list of accepted indications adapted from the US Food and Drug Administration (FDA)-approved list. RESULTS In all, 1,025 inpatients were documented. Of the 477 (46.5%) inpatients using PPIs, only 219 (45.9%) fulfilled the FDA-approved indications, while the majority (n = 258, 54.1%) did not. Overall, PPIs were not strictly indicated for use in 206 (43.2%) inpatients, according to FDA criteria. Of the 477 inpatients on PPIs, 52 (10.9%) had borderline indications based on expert consensus/guidelines other than FDA criteria. CONCLUSION Although the use of PPIs is prevalent in hospitals, less than half of the hospitalised patients using PPIs in our study had evidence-based indications that supported such use. The overuse of PPIs has a negative impact on healthcare costs and may lead to adverse effects. Steps to curb the inappropriate use of PPIs should address factors such as indications for the initiation of PPIs, and reassessment of the need for ongoing PPI use in inpatients upon discharge and during outpatient reviews. PMID:25091884
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2004-03-16
The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-16
... completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is... availability of a preamendments class III devices strategy document. The strategy document set forth FDA's... approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180...
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Fang, Hong; Harris, Stephen C; Liu, Zhichao; Zhou, Guangxu; Zhang, Guoping; Xu, Joshua; Rosario, Lilliam; Howard, Paul C; Tong, Weida
2016-10-01
Here, we provide a concise overview of US Food and Drug Administration (FDA) drug labeling, which details drug products, drug-drug interactions, adverse drug reactions (ADRs), and more. Labeling data have been collected over several decades by the FDA and are an important resource for regulatory research and decision making. However, navigating through this data is challenging. To aid such navigation, the FDALabel database was developed, which contains a set of approximately 80000 labeling data. The full-text searching capability of FDALabel and querying based on any combination of specific sections, document types, market categories, market date, and other labeling information makes it a powerful and attractive tool for a variety of applications. Here, we illustrate the utility of FDALabel using case scenarios in pharmacogenomics biomarkers and ADR studies. Published by Elsevier Ltd.
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Inert Reassessment Document for Copper Naphthenate - CAS No. 1338-02-9
Copper naphthenate is approved by the Food and Drug Administration (FDA) as an indirect food additive, and for use in veterinary topical applications to the surface of horse and pony hooves that have Thrush.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-27
...The Food and Drug Administration (FDA) is extending the comment period to November 30, 2011, for the notice entitled, ``Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012'' that appeared in the Federal Register of August 1, 2011 (76 FR 45820). In that document, FDA announced the establishment of a docket to obtain comments that would be considered in establishing the fee rates for fiscal year (FY) 2013. In particular, the Agency provided the current FY 2012 fees and requested public comments to the document and intends to consider such comments, as well as experience and additional data gained in implementing these fees in FY 2012, in establishing the fee rates for FY 2013. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
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Shah, Vinod P; Amidon, Gordon L
2014-09-01
The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.
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Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T
2017-02-01
The US Food and Drug Administration (FDA) approves high-risk medical devices based on premarket pivotal clinical studies demonstrating reasonable assurance of safety and effectiveness and may require postapproval studies (PAS) to further inform benefit-risk assessment. We conducted a cross-sectional analysis using publicly available FDA documents to characterize industry-sponsored pivotal studies and PAS of high-risk devices used in the treatment of otolaryngologic diseases. Between 2000 and 2014, the FDA approved 23 high-risk otolaryngologic devices based on 28 pivotal studies. Median enrollment was 118 patients (interquartile range, 67-181), and median duration of longest primary effectiveness end point follow-up was 26 weeks (interquartile range, 16-96). Fewer than half were randomized (n = 13, 46%), blinded (n = 12, 43%), or controlled (n = 10, 36%). The FDA required 23 PASs for 16 devices (70%): almost two-thirds (n = 15, 65%) monitored long-term performance, and roughly one-third (n = 8, 35%) focused on subgroups. Otolaryngologists should be aware of limitations in the strength of premarket evidence when considering the use of newly approved devices.
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Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V
2010-08-01
To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text. The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's encouragement of standard definitions and definable expectations for investigators and industry sponsors. Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (C-CASA)-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed. Copyright 2010 Physicians Postgraduate Press, Inc.
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Schadow, Gunther
2005-01-01
Prescribing errors are an important cause of adverse events, and lack of knowledge of the drug is a root cause for prescribing errors. The FDA is issuing new regulations that will make the drug labels much more useful not only to physicians, but also to computerized order entry systems that support physicians to practice safe prescribing. For this purpose, FDA works with HL7 to create the Structured Product Label (SPL) standard that includes a document format as well as a drug knowledge representation, this poster introduces the basic concepts of SPL.
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United States Food and Drug Administration Regulation of Gene and Cell Therapies.
Bailey, Alexander M; Arcidiacono, Judith; Benton, Kimberly A; Taraporewala, Zenobia; Winitsky, Steve
2015-01-01
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-15
... number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean..., MD 20850, domini.bean@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520...
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White House Announcement on the Regulation of Biotechnology
The White House posted a blog unveiling documents as part of the Administration’s continuing effort to modernize the federal regulatory system for biotechnology products as well as clarify various roles of the EPA, FDA in evaluating new biotechnologies.
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ERIC Educational Resources Information Center
General Accounting Office, Washington, DC.
This report presents information on the status of the safety and use of polio vaccines in the United States. Topics discussed include: (1) the role of the Food and Drug Administration (FDA) in processing an inactivated polio vaccine license application; (2) the steps the federal government has taken to improve the safety of the vaccine; (3) the…
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47 CFR 1.734 - Specifications as to pleadings, briefs, and other documents; subscription.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 47 Telecommunication 1 2013-10-01 2013-10-01 false Specifications as to pleadings, briefs, and other documents; subscription. 1.734 Section 1.734 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... submitted both as hard copies and on computer disk formatted to be compatible with the Commission's computer...
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47 CFR 1.734 - Specifications as to pleadings, briefs, and other documents; subscription.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 47 Telecommunication 1 2012-10-01 2012-10-01 false Specifications as to pleadings, briefs, and other documents; subscription. 1.734 Section 1.734 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... submitted both as hard copies and on computer disk formatted to be compatible with the Commission's computer...
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47 CFR 1.734 - Specifications as to pleadings, briefs, and other documents; subscription.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 47 Telecommunication 1 2014-10-01 2014-10-01 false Specifications as to pleadings, briefs, and other documents; subscription. 1.734 Section 1.734 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... submitted both as hard copies and on computer disk formatted to be compatible with the Commission's computer...
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2003-06-02
The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.
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Ilic, Nina; Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana
2012-12-01
Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis.
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Ilic, Nina; Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana
2012-12-01
A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level.
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Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana
2012-01-01
Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to “medicinal products” and “marketing authorization(s),” the FDA documents discussed “drug(s)” or “biologic(s),” and the TGA documents referred to “biological(s).” Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis. PMID:23283551
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MO-F-16A-08: Have An Impact On More Patients From Your Ideas And Inventions
DOE Office of Scientific and Technical Information (OSTI.GOV)
Morton, R
Purpose: To inform physicists how to obtain an FDA 510(k) clearance for the innovations they use in their facility and to make those ideas widely available to patients throughout the U.S. Methods: Give advice from 20 years experience of assisting in well over 100 successful 510(k) clearances. Results: Learn how to develop a 510(k) submission. Conclusion: Many physicists, physicians and radiation therapists have developed innovations that that are helpful to the patients in their institution. But, many of these innovations deserve to be made available to patients throughout the United States. The author, a Certified Radiological Physicist and former FDAmore » employee, has consulted for over twenty years for inventors, start-ups and established medical device manufacturers to bring new devices to market in the U.S. and to assist them to established FDA compliant quality systems for manufacturing. In this presentation the audience will learn the important points for deciding to go forward with obtaining a Premarket Notification clearance [also known as a 510(k) clearance] to legally market a medical device in the United States. The FDA has published guidelines for submitting a 510(k) application. However, the methods used to efficiently develop the documentation for submission and to obtain clearance in the shortest possible time comes from the author's experience in assisting well over one hundred successful 510(k) clearances.Whether you want to start your own company or to market your idea to an established medical device manufacturer, the value of your innovation increases with a documented 510(k) clearance from FDA.« less
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... for Devices and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov...'' from CDRH, you may either send an email request to [email protected] to receive an electronic copy of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-15
... are companies that seek to export medical devices. FDA's estimate of the reporting burden is based on... January 26, 2010, were reported as zero. The correct figure is in Table 1 of this document. [[Page 19652...
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Generic School Grounds Design Brief.
ERIC Educational Resources Information Center
Dorset County Council, Dorchester (England).
This document was produced to provide architects, planners, and builders with an educational design brief for Dorset, England school grounds. The County Education Planning and Development Department will use it as an educational and curriculum statement to complement their more detailed and specific building briefs. The brief uses many of the…
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Improving the postmarket surveillance of total joint arthroplasty devices.
Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H
2008-01-01
To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.
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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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Use of Symbols in Labeling. Final rule.
2016-06-15
The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement "Rx only" or "[rx] only" in the labeling for prescription devices.
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Comparison of oncology drug approval between Health Canada and the US Food and Drug Administration.
Ezeife, Doreen A; Truong, Tony H; Heng, Daniel Y C; Bourque, Sylvie; Welch, Stephen A; Tang, Patricia A
2015-05-15
The drug approval timeline is a lengthy process that often varies between countries. The objective of this study was to delineate the Canadian drug approval timeline for oncology drugs and to compare the time to drug approval between Health Canada (HC) and the US Food and Drug Administration (FDA). In total, 54 antineoplastic drugs that were approved by the FDA between 1989 and 2012 were reviewed. For each drug, the following milestones were determined: the dates of submission and approval for both the FDA and HC and the dates of availability on provincial drug formularies in Canadian provinces and territories. The time intervals between the aforementioned milestones were calculated. Of 54 FDA-approved drugs, 49 drugs were approved by HC at the time of the current study. The median time from submission to approval was 9 months (interquartile range [IQR], 6-14.5 months) for the FDA and 12 months (IQR, 10-21.1 months) for HC (P < .0006). The time from HC approval to the placement of a drug on a provincial drug formulary was a median of 16.7 months (IQR, 5.9-27.2 months), and there was no interprovincial variability among the 5 Canadian provinces that were analyzed (P = .5). The time from HC submission to HC approval takes 3 months longer than the same time interval for the FDA. To the authors' knowledge, this is the first documentation of the time required to bring an oncology drug from HC submission to placement on a provincial drug formulary. © 2015 American Cancer Society.
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76 FR 81513 - Guidance for Industry: Prevention of Salmonella
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
...] Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The document provides guidance to egg producers on how to comply with certain provisions contained in FDA's...
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21 CFR 870.4350 - Cardiopulmonary bypass oxygenator.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass oxygenator. 870.4350... bypass oxygenator. (a) Identification. A cardiopulmonary bypass oxygenator is a device used to exchange... the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions...
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21 CFR 870.4350 - Cardiopulmonary bypass oxygenator.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass oxygenator. 870.4350... bypass oxygenator. (a) Identification. A cardiopulmonary bypass oxygenator is a device used to exchange... the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions...
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75 FR 60759 - Enforcement Action Plan for Promotion and Advertising Restrictions; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-01
...] Enforcement Action Plan for Promotion and Advertising Restrictions; Availability AGENCY: Food and Drug... availability of a document entitled ``Enforcement Action Plan for Promotion and Advertising Restrictions'' (Enforcement Action Plan), which describes FDA's plan to enforce the restrictions on promotion and advertising...
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21 CFR 314.445 - Guidance documents.
Code of Federal Regulations, 2010 CFR
2010-04-01
... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance... directed to the Office of Training and Communications, Division of Drug Information, Center for Drug...
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78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-27
...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29, 2010 (75 FR 15376), to establish standards that would be considered in determining whether the major statement in direct-to-consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. FDA is announcing that it has added a document to the docket for the proposed rulemaking concerning a study entitled: ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to- Consumer Prescription Drug Television Advertisements'' (Distraction Study). This study was designed to investigate some advertising factors that could influence consumers' understanding of a drug's risks. This document reopens the comment period for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards.
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Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule.
2011-04-25
The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device.
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Ahuja, Vishal; Sohn, Min-Woong; Birge, John R; Syverson, Chad; Budiman-Mak, Elly; Emanuele, Nicholas; Cooper, Jennifer M; Huang, Elbert S
2015-12-01
Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later. While large declines have been documented in rosiglitazone use in clinical practice, little is known about how the use of rosiglitazone and other glucose-lowering drugs varied within the Department of Veterans Affairs (VA), surrounding the FDA alerts. Understanding this variation within integrated health care systems is essential to formulating policies that enhance patient protection and quality of care. To document variation in the use of rosiglitazone and other glucose- lowering drugs across 21 Veterans Integrated Service Networks (VISNs). We conducted a retrospective analysis of drug use patterns for all major diabetes drugs in a national cohort of 550,550 veterans with diabetes from 2003 to 2008. This included the time periods when rosiglitazone was added to (November 2003) and removed from (October 2007) the VA national formulary (VANF). We employed multivariable logistic regression models to statistically estimate the association between a patient's location and the patient's odds of using rosiglitazone. Aggregate rosiglitazone use increased monotonically from 7.7%, in the quarter it was added to the VANF (November 4, 2003), to a peak of 15.3% in the quarter when the FDA issued the safety alert. Rosiglitazone use decreased sharply afterwards, reaching 3.4% by the end of the study period (September 30, 2008). The use of pioglitazone, another glucose-lowering drug in the same class as rosiglitazone, was low when the FDA issued the safety alert (0.4%) but increased sharply afterwards, reaching 3.6% by the end of the study period. Insulin use increased monotonically; metformin use remained relatively flat; and sulfonylurea use exhibited a general declining trend throughout the study period. Statistically significant geographic variation was observed in rosiglitazone use throughout the study period. The prevalence range, defined as the range of minimum to maximum use across VISNs was 3.7%-12.4% in the first quarter (January 1 to March 31, 2003); 1.0%-5.5% in the last quarter of study period (July 1 to September 30, 2008); and reached a peak of 9.6%-25.5% in the quarter when the FDA safety alert was issued (April 1 to March 31, 2007). In 5 VISNs, peak rosiglitazone use occurred before the FDA issued the safety alert. The odds ratio of using rosiglitazone in a given VISN varied from 0.55 (95% CI = 0.52-0.59; VISN 10) to 1.58 (95% CI = 1.50-1.66; VISN 15), with VISN 1 being the reference region. The variation was higher in the periods after the FDA issued the safety alert. Much less variation was observed in the use of pioglitazone, metformin, sulfonylurea, and insulin. Our results show statistically significant variation in the way VISNs within the VA responded to the FDA alerts, suggesting a need for mechanisms that disseminate information and guidelines for drug use in a consistent and reliable manner. Further study of regions that adopted ideal practices earlier may provide lessons for regional leadership and practice culture within integrated health care systems.
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Foreword: Follow-on Biologics: Implementation Challenges and Opportunities.
Paradise, Jordan
2011-01-01
This Book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future of follow-on biologics in the United States resulting from the Patient Protection and Affordable Care Act of March 2010. THE BIOLOGIC PRICE COMPETITION AND INNOVATION ACT OF 2010. The March 23, 2010, enactment of the Patient Protection and Affordable Care Act (PPACA) and the companion Health Care and Education Affordability Reconciliation Act of 2010 ushered in landmark reform of the American health care system. Along with sweeping overhauls of the health care system generally, PPACA also provides a new regulatory challenge for the Food and Drug Administration (FDA). A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are "biosimilar" to an existing marketed product. The brief introduction will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA's development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained with this Book of the Seton Hall Law Review.
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COSMIC program documentation experience
NASA Technical Reports Server (NTRS)
Kalar, M. C.
1970-01-01
A brief history of COSMIC as it relates to the handling of program documentation is summarized; the items that are essential for computer program documentation are also discussed. COSMIC documentation and program standards handbook is appended.
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78 FR 63481 - Therapeutic Area Standards Initiative Project Plan; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-24
...] Therapeutic Area Standards Initiative Project Plan; Availability AGENCY: Food and Drug Administration, HHS... Therapeutic Area Standards Initiative Project Plan. This therapeutic area (TA) Project Plan will be the primary document for guiding all major aspects of FDA's multi-year initiative to develop and implement TA...
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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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21 CFR 25.52 - Environmental impact statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Environmental impact statements. 25.52 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Public Participation and Notification of Environmental Documents § 25.52 Environmental impact statements. (a) If FDA determines that an EIS is necessary for an action involving...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-04
... 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; Correction... ``Antiseptic Patient Preoperative Skin Preparation Products.'' The document was published with an incorrect...
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Ducharme, Lori J.; Chandler, Redonna K.; Harris, Alex H. S.
2015-01-01
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), and Veterans Health Administration (VHA) share an interest in promoting high quality, rigorous health services research to improve the availability and utilization of evidence-based treatment for substance use disorders (SUD). Recent and continuing changes in the healthcare policy and funding environments prioritize the integration of evidence-based substance abuse treatments into primary care and general medical settings. This area is a prime candidate for implementation research. Recent and ongoing implementation projects funded by these agencies are reviewed. Research in five areas is highlighted: screening and brief intervention for risky drinking; screening and brief intervention for tobacco use; uptake of FDA-approved addiction pharmacotherapies; safe opioid prescribing; and disease management. Gaps in the portfolios, and priorities for future research, are described. PMID:26233697
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Ribisl, Kurt M
2012-01-01
This paper is part of a collection that identifies research priorities that will help guide the efforts of the U.S. Food and Drug Administration (FDA) as it regulates tobacco products. This paper examines the major provisions related to tobacco product advertising, marketing, sales, and distribution included in Public Law 111-31, the "Family Smoking Prevention and Tobacco Control Act". This paper covers 5 areas related to (a) marketing regulations (e.g., ban on color and imagery in ads, ban on nontobacco gifts with purchase); (b) granting FDA authority over the sale, distribution, accessibility, advertising, and promotion of tobacco and lifting state preemption over advertising; (c) remote tobacco sales (mail order and Internet); (d) prevention of illicit and cross-border trade; and (e) noncompliant export products. Each of the 5 sections of this paper provides a description and brief history of regulation, what is known about this regulatory strategy, and research opportunities.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-31
... document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0145] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-09
... document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...
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Using the Structured Product Labeling format to index versatile chemical data (ACS Spring meeting)
Structured Product Labeling (SPL) is a document markup standard approved by the Health Level Seven (HL7) standards organization and adopted by the FDA as a mechanism for exchanging product and facility information. Product information provided by companies in SPL format may be ac...
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Code of Federal Regulations, 2010 CFR
2010-04-01
..., and throat devices intended for human use that are in commercial distribution. (b) The identification..., nose, and throat device that has two or more types of uses (e.g., used both as a diagnostic device and...) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0881] Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations... ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' The document was published...
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78 FR 63872 - Turtles Intrastate and Interstate Requirements
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1240 [Docket No. FDA-2013-N-0639] Turtles Intrastate and Interstate Requirements Correction In rule document 2013-17751 appearing on pages 44878-44881 in the issue of July 25, 2013, make the following correction: On page 44879...
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21 CFR 878.4495 - Stainless steel suture.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Stainless steel suture. 878.4495 Section 878.4495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...
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21 CFR 884.5970 - Clitoral engorgement device.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clitoral engorgement device. 884.5970 Section 884.5970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-28
... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... document proposed to amend certain neurological and physical medicine device regulations to establish... to amend certain neurological device and physical medicine device regulations to establish special...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
...; (Formerly FDA-2007D-0393)] Guidance for Industry: Blood Establishment Computer System Validation in the User... Industry: Blood Establishment Computer System Validation in the User's Facility'' dated April 2013. The... document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-07
... assessment. In some cases, a PMA may include multiple studies designed to answer different scientific... designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2011-N-0505] Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent... preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...
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Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo
2018-02-01
This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.
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The impact of the written request process on drug development in childhood cancer.
Snyder, Kristen M; Reaman, Gregory; Avant, Debbie; Pazdur, Richard
2013-04-01
The Food and Drug Administration (FDA) Modernization Act, enacted in 1997, created a pediatric exclusivity incentive allowing sponsors to qualify for an additional 6 months of marketing exclusivity after satisfying the requirements outlined in the Written Request (WR). This review evaluates the impact of the WR mechanism on the development of oncology drugs in children. A search of the FDA document archiving, reporting, and regulatory tracking system was performed for January 1, 2000 to December 31, 2010. Drugs were identified and pediatric-specific labeling information was obtained from Drugs@fda.gov and FDA Pediatric Labeling Changes Table. Fifty WRs have been issued for oncology drugs. Pediatric studies have been submitted for 14 drugs. Thirteen received pediatric exclusivity. As of December 31, 2010, labeling changes have been made for 11 drugs. Three drugs were approved for pediatric use. WRs have provided a mechanism to promote the study of drugs in pediatric malignancies. Information from studies resulting from the WRs regarding safety, pharmacokinetics, and tolerability of oncology drugs has been incorporated into pediatric labeling for 11/14 of the drugs. Earlier communication and collaboration between the FDA, National Cancer Institute, clinical investigators, and commercial sponsors are envisioned to facilitate the identification and prioritization of emerging new drugs of interest for WR consideration. Since this is the only regulatory mechanism, resulting from specific legislative initiatives relevant to cancer drug development for children, efforts to enhance its impact on increasing drug approval for pediatric cancer indications are warranted. Copyright © 2013 Wiley Periodicals, Inc.
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Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E
2016-04-01
In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe < 30% (89.6% vs 65.8%, P = .0015). PK studies to assess the impact of dialysis were conducted for 31.7% of NCEs that had a renal study: a greater proportion of high fe NCEs were studied (44.2% vs 26.0%, P = .0335). No significant change in frequency or rigor of PK studies was detected over time. The majority of NCEs (76.3%) with a renal study provided specific dosing recommendations in the API. The adoption of the 1998 FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs. © 2015, The American College of Clinical Pharmacology.
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[Comparative study of device labeling regulation in U.S.A. and China].
Li, Fei; Wei, Jing; Ma, Yanbin; Li, Zhu
2010-09-01
To provide references for the evolvement of medical devices labeling and manual administration in China, By content analysis, 10 juristic documents relevant to device labeling and manual were collected from FDA website, compared to which, the federal regulation was mainly analyzed. There are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice, A set of comprehensive juristic system for device labeling has been established by FDA. from which China should draw experience, to administrate the prescription devices and the over-the-counter devices in classification, and set up device labeling guidance, thus guarantee the safety and efficacy of device.
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Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Needham, Shane; Couerbe, Philippe; Lansing, Tim; Bhatti, Masood; Sheldon, Curtis; Hayes, Roger; Islam, Rafiq; Lin, Zhongping; Garofolo, Wei; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocha, Thais; Jardieu, Paula; Truog, James; Lin, Jenny; Lundberg, Richard; Breau, Alan; Dilger, Carmen; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Jenkins, Rand; Nicholson, Robert; Lin, Ming Hung; Karnik, Shane; DeMaio, William; Smith, Kirk; Cojocaru, Laura; Allen, Mike; Fatmi, Saadya; Sayyarpour, Farhad; Malone, Michele; Fang, Xinping
2012-04-01
The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.
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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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-31
...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.
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Edlich, Richard F; Long, William B; Gubler, K Dean; Rodeheaver, George T; Thacker, John G; Borel, Lise; Chase, Margot E; Cross, Catherine L; Fisher, Allyson L; Lin, Kant Y; Cox, Mary J; Zura, Robert B
2009-02-01
During the last 25 years, scientific experimental and clinical studies have documented the dangers of cornstarch powder on examination and surgical gloves because the cornstarch promotes wound infection, causes serious peritoneal adhesions and granulomatous peritonitis, and is a well-documented vector of the latex allergy epidemic in the world. Realizing the dangers of cornstarch on examination and surgical gloves, Germany's regulations of personal protective equipment banned the use of surgical glove powder cornstarch in 1997. In 2000, the Purchasing and Supply agency for the United Kingdom ceased to purchase any gloves lubricated with cornstarch. Realizing the dangers of cornstarch-powdered gloves, many hospitals and clinics in the United States have banned the use of cornstarch-powdered examination and surgical gloves. Hospitals that have banned cornstarch in their examination and surgical gloves have noted a marked reduction in the latex allergy epidemic in their facilities. Realizing the dangers of cornstarch-powdered examination and surgical gloves, Dr Sheila A. Murphey, branch chief, Infection Control Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation, Center for Devices and Radiological Health of the Food and Drug Administration (FDA), recommended that a Citizen's Petition be filed to the FDA to ban cornstarch on surgical and examination gloves. The 12 authors of this report have attached the enclosed petition to the FDA to ban the use of cornstarch on all synthetic and latex examination and surgical gloves used in the United States.
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Understanding Philip Morris's pursuit of US government regulation of tobacco
McDaniel, P; Malone, R
2005-01-01
Objective: To investigate Philip Morris's support of US Food and Drug Administration (FDA) regulation of tobacco products and analyse its relationship to the company's image enhancement strategies. Data sources: Internal Philip Morris documents released as part of the Master Settlement Agreement. Methods: Searches of the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu) beginning with such terms as "FDA" and "regulatory strategy" and expanding to include relevant new terms. Results: Philip Morris's support for government regulation of tobacco is part of a broader effort to address its negative public image, which has a damaging impact on the company's stock price, political influence, and employee morale. Through regulation, the company seeks to enhance its legitimacy, redefine itself as socially responsible, and alter the litigation environment. Whereas health advocates frame tobacco use as a public health policy issue, Philip Morris's regulatory efforts focus on framing tobacco use as an individual choice by informed adults to use a risky product. This framing allows Philip Morris to portray itself as a reasonable and responsible manufacturer and marketer of risky products. Conclusions: Philip Morris's ability to improve its image through support of FDA regulation may undermine tobacco control efforts aimed at delegitimising the tobacco industry. It may also create the impression that Philip Morris's products are being made safer and ultimately protect the company from litigation. While strong regulation of tobacco products and promotion remain critical public health goals, previous experiences with tobacco regulation show that caution may be warranted. PMID:15923470
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Understanding Philip Morris's pursuit of US government regulation of tobacco.
McDaniel, P A; Malone, R E
2005-06-01
To investigate Philip Morris's support of US Food and Drug Administration (FDA) regulation of tobacco products and analyse its relationship to the company's image enhancement strategies. Internal Philip Morris documents released as part of the Master Settlement Agreement. Searches of the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu) beginning with such terms as "FDA" and "regulatory strategy" and expanding to include relevant new terms. Philip Morris's support for government regulation of tobacco is part of a broader effort to address its negative public image, which has a damaging impact on the company's stock price, political influence, and employee morale. Through regulation, the company seeks to enhance its legitimacy, redefine itself as socially responsible, and alter the litigation environment. Whereas health advocates frame tobacco use as a public health policy issue, Philip Morris's regulatory efforts focus on framing tobacco use as an individual choice by informed adults to use a risky product. This framing allows Philip Morris to portray itself as a reasonable and responsible manufacturer and marketer of risky products. Philip Morris's ability to improve its image through support of FDA regulation may undermine tobacco control efforts aimed at delegitimising the tobacco industry. It may also create the impression that Philip Morris's products are being made safer and ultimately protect the company from litigation. While strong regulation of tobacco products and promotion remain critical public health goals, previous experiences with tobacco regulation show that caution may be warranted.
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Documentation for the Waste Reduction Model (WARM)
This page describes the WARM documentation files and provides links to all documentation files associated with EPA’s Waste Reduction Model (WARM). The page includes a brief summary of the chapters documenting the greenhouse gas emission and energy factors.
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Martin, S T; Cardwell, S M; Nailor, M D; Gabardi, S
2014-04-01
Use of rituximab, a chimeric monoclonal antibody directed at the CD20 antigen, continues to increase in solid organ transplantation (SOT) for several off-label uses. In September 2013, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication to oncology, rheumatology and pharmacy communities outlining a new Boxed Warning for rituximab. Citing 109 cases of fatal hepatitis B virus (HBV) reactivation in persons receiving rituximab therapy with previous or chronic HBV infection documented in their Adverse Event Reporting System (AERS), the FDA recommends screening for HBV serologies in all patients planned to receive rituximab and antiviral prophylaxis in any patient with a positive history of HBV infection. There is a lack of data pertaining to this topic in the SOT population despite an increase in off-label indications. Previous reports suggest patients receiving rituximab, on average, were administered six doses prior to HBV reactivation. Recommendations on prophylaxis, treatment and re-challenging patients with therapy after resolution of reactivation remain unclear. Based on data from the FDA AERS and multiple analyses in oncology, SOT providers utilizing rituximab should adhere to the FDA warnings and recommendations regarding HBV reactivation until further data are available in the SOT population. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.
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7 CFR 1753.58 - Closeout documents.
Code of Federal Regulations, 2013 CFR
2013-01-01
... followed in the preparation of closeout documents for the FAP. (2) The period between the completion of... documents required to close the FAP are listed in the following table. The following is a brief description...
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7 CFR 1753.58 - Closeout documents.
Code of Federal Regulations, 2012 CFR
2012-01-01
... followed in the preparation of closeout documents for the FAP. (2) The period between the completion of... documents required to close the FAP are listed in the following table. The following is a brief description...
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7 CFR 1753.58 - Closeout documents.
Code of Federal Regulations, 2014 CFR
2014-01-01
... followed in the preparation of closeout documents for the FAP. (2) The period between the completion of... documents required to close the FAP are listed in the following table. The following is a brief description...
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7 CFR 1753.58 - Closeout documents.
Code of Federal Regulations, 2010 CFR
2010-01-01
... followed in the preparation of closeout documents for the FAP. (2) The period between the completion of... documents required to close the FAP are listed in the following table. The following is a brief description...
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7 CFR 1753.58 - Closeout documents.
Code of Federal Regulations, 2011 CFR
2011-01-01
... followed in the preparation of closeout documents for the FAP. (2) The period between the completion of... documents required to close the FAP are listed in the following table. The following is a brief description...
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Ducharme, Lori J; Chandler, Redonna K; Harris, Alex H S
2016-01-01
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), and Veterans Health Administration (VHA) share an interest in promoting high quality, rigorous health services research to improve the availability and utilization of evidence-based treatment for substance use disorders (SUD). Recent and continuing changes in the healthcare policy and funding environments prioritize the integration of evidence-based substance abuse treatments into primary care and general medical settings. This area is a prime candidate for implementation research. Recent and ongoing implementation projects funded by these agencies are reviewed. Research in five areas is highlighted: screening and brief intervention for risky drinking; screening and brief intervention for tobacco use; uptake of FDA-approved addiction pharmacotherapies; safe opioid prescribing; and disease management. Gaps in the portfolios, and priorities for future research, are described. Published by Elsevier Inc.
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Fibrin sealant: past, present, and future: a brief review.
Spotnitz, William D
2010-04-01
Fibrin sealant is a two-component topical hemostat, sealant, and tissue adhesive consisting of fibrinogen and thrombin that has been used in the United States as a blood bank- or laboratory-derived product since the 1980s and has been commercially available since 1998. Initially, surgeons employed hospital-based materials because of the lack of availability of a commercially produced agent. At present, there are five U.S. Food and Drug Administration (FDA)-approved forms including products derived from pooled or autologous human plasma as well as bovine plasma. On-label indications include hemostasis, colonic sealing, and skin graft attachment. Recent clinical and experimental uses include tissue or mesh attachment, fistula closure, lymphatic sealing, adhesion prevention, drug delivery, and tissue engineering. The modern literature on fibrin sealant now exceeds 3000 articles and continues to expand. This brief review presents the history of this material, its present clinical use, and its future applications.
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75 FR 22815 - Impact of Dissolvable Tobacco Use on Public Health; Request for Comments
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0123] Impact of Dissolvable Tobacco Use on Public Health; Request for Comments Correction In notice document 2010-6216 beginning on page 13556 in the issue of Monday, March 22, 2010, make the following correction...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-07
...] Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update... Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar... guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-24
... document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0268...
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76 FR 37291 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2011-F-0171] Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Correction... certain articles of food sold from vending machines. The document published with several errors including...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... gastroenterology-urology devices intended for human use that are in commercial distribution. (b) The identification... gastroenterology-urology device that has two or more types of uses (e.g., used both as a diagnostic device and as a... documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-15
... Review Boards--OMB Control Number 0910-0130--Extension When reviewing clinical research studies regulated... participating in clinical research. In the Federal Register of August 17, 2010 (75 FR 50766), FDA published a 60... IRB will use in performing its functions; the research protocols, informed consent documents, progress...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-15
... availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk... versus its probable risk. This draft guidance sets out the factors FDA considers when making this... factors to consider when making benefit-risk determinations in medical device premarket review. It does...
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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-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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21 CFR 878.5020 - Nonabsorbable polyamide surgical suture.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonabsorbable polyamide surgical suture. 878.5020 Section 878.5020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Industry and FDA.” See § 878.1(e) for the availability of this guidance document. [56 FR 24685, May 31...
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21 CFR 878.4840 - Absorbable polydioxanone surgical suture.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Absorbable polydioxanone surgical suture. 878.4840 Section 878.4840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Industry and FDA.” See § 878.1(e) for the availability of this guidance document. [67 FR 77676, Dec. 19...
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21 CFR 878.4493 - Absorbable poly(glycolide/l-lactide) surgical suture.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Absorbable poly(glycolide/l-lactide) surgical suture. 878.4493 Section 878.4493 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and...
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21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonabsorbable expanded polytetrafluoroethylene surgical suture. 878.5035 Section 878.5035 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document. [65 FR 20735...
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21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... type of device is designed to achieve biological fixation to bone without the use of bone cement. This... bearing is rigidly secured to the metal tibial base plate. (b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0146] Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment; Availability...). The document announced the availability of a guidance for industry entitled ``Irritable Bowel Syndrome...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-15
... Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice... document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that... the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...
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Medication Warnings: New Concerns for ADHD and Comorbid Motor Problems
ERIC Educational Resources Information Center
Obringer, S. John; Coffey, Kenneth
2007-01-01
The FDA committees and the manufacturers of the most common ADHD drugs have recently modified the prescription information to include warnings on sudden death, serious cardiovascular events, and suicidal ideation. The purpose of this article was to document the association between traumatic brain injury, cerebral palsy, and ADHD and to clarify the…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave... INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Mary... Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/Medical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-28
... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CONTACT: For devices regulated by CDRH: Ruth Fischer, Center for Devices and Radiological Health, Food and... search capability is available for all CDRH guidance documents at http://www.fda.gov/MedicalDevices...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-14
... and biological products, animal drugs, and medical devices to demonstrate the safety and utility of..., calibration, and testing records; (4) documentation of feed and water analyses, and animal treatments; (5... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0075...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...
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77 FR 71009 - Framework for Pharmacy Compounding: State and Federal Roles
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-28
... Federal Roles.'' At this public meeting, FDA and State representatives will share their perspectives. Date... and/or other countries. If for some reason the test page does not work, that is not a definite... persons may submit either written comments regarding this document to the Division of Dockets Management...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-09
... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...
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78 FR 51192 - Secure Supply Chain Pilot Program
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-20
... (PDF) and using the Electronic Common Technical Document (eCTD) format and the Electronic Submissions.... The PDF file name should contain ``3676'' as part of the file name, and the eCTD leaf title should.... For further information regarding eCTD, please refer to the Web site at http://www.fda.gov/Drugs...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-15
.... Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in... electronically via the Electronic Submission Gateway (ESG); and the guidance document entitled, ``Recommendations... to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
This large document provides a catalog of the location of large numbers of reports pertaining to the charge of the Presidential Advisory Committee on Human Radiation Research and is arranged as a series of appendices. Titles of the appendices are Appendix A- Records at the Washington National Records Center Reviewed in Whole or Part by DoD Personnel or Advisory Committee Staff; Appendix B- Brief Descriptions of Records Accessions in the Advisory Committee on Human Radiation Experiments (ACHRE) Research Document Collection; Appendix C- Bibliography of Secondary Sources Used by ACHRE; Appendix D- Brief Descriptions of Human Radiation Experiments Identified by ACHRE,more » and Indexes; Appendix E- Documents Cited in the ACHRE Final Report and other Separately Described Materials from the ACHRE Document Collection; Appendix F- Schedule of Advisory Committee Meetings and Meeting Documentation; and Appendix G- Technology Note.« less
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Healthcare software assurance.
Cooper, Jason G; Pauley, Keith A
2006-01-01
Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA's software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted.
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17 CFR 10.102 - Review of initial decisions.
Code of Federal Regulations, 2010 CFR
2010-04-01
... the appeal with respect to the issues presented, and the reasons therefor, and citations to supporting... answering brief generally shall follow the same style as prescribed for the appeal brief but may omit a... reference citations to the record contained in its brief or in any other document. If an appellee deems it...
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ERIC Educational Resources Information Center
Lane, Brett; Souvanna, Phomdaen
2014-01-01
This College Success Research Brief is one of a series of briefs documenting the implementation and impact of Mass Insight's College Success/STEM program. The research briefs are intended to share key findings, highlight ongoing questions and lines of inquiry, and inform the thinking of practitioners and policymakers on how to scale up efforts to…
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22 CFR 41.105 - Supporting documents and fingerprinting.
Code of Federal Regulations, 2013 CFR
2013-04-01
... Section 41.105 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF NONIMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.105 Supporting documents... receive a nonimmigrant visa. All documents and other evidence presented by the alien, including briefs...
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22 CFR 41.105 - Supporting documents and fingerprinting.
Code of Federal Regulations, 2011 CFR
2011-04-01
... Section 41.105 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF NONIMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.105 Supporting documents... receive a nonimmigrant visa. All documents and other evidence presented by the alien, including briefs...
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22 CFR 41.105 - Supporting documents and fingerprinting.
Code of Federal Regulations, 2012 CFR
2012-04-01
... Section 41.105 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF NONIMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.105 Supporting documents... receive a nonimmigrant visa. All documents and other evidence presented by the alien, including briefs...
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22 CFR 41.105 - Supporting documents and fingerprinting.
Code of Federal Regulations, 2014 CFR
2014-04-01
... Section 41.105 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF NONIMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.105 Supporting documents... receive a nonimmigrant visa. All documents and other evidence presented by the alien, including briefs...
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22 CFR 41.105 - Supporting documents and fingerprinting.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Section 41.105 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF NONIMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.105 Supporting documents... receive a nonimmigrant visa. All documents and other evidence presented by the alien, including briefs...
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Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.
Ramasamy, Abhilasha; Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Argoff, Charles; Freynhagen, Rainer; Wallace, Mark; McCarrier, Kelly P; Bushnell, Donald M; Hatley, Noël V; Patrick, Donald L
2017-06-01
To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims. Literature review of existing PRO measures. Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes. Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance. There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
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Technical publications catalog : October 2006-September 2007
DOT National Transportation Integrated Search
2008-01-01
This is a comprehensive listing of Turner-Fairbank Highway Research Center research documents published from October 2006 through September 2007, and includes listings of fact sheets, flyers, product briefs, reports, summaries, and TechBriefs.
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Technical publications catalog : October 2003-September 2005
DOT National Transportation Integrated Search
2005-01-01
This is a comprehensive listing of Turner-Fairbank Highway Research Center research documents published from October 2003 through September 2005, and includes listings of fact sheets, flyers, product briefs, summaries, and TechBriefs.
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Technical publications catalog : October 2007-September 2008
DOT National Transportation Integrated Search
2009-01-01
This is a comprehensive listing of Turner-Fairbank Highway Research Center research documents published from October 2007 through September 2008, and includes listings of fact sheets, flyers, product briefs, reports, summaries, and TechBriefs.
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76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-23
...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.
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Bennette, Caroline S; Richards, Catherine; Sullivan, Sean D; Ramsey, Scott D
2016-05-01
The cost of treating cancer has risen to unprecedented heights, putting tremendous financial pressure on patients, payers, and society. Previous studies have documented the rising prices of cancer drugs at launch, but less critical attention has been paid to the cost of these drugs after launch. We used pharmacy claims for commercially insured individuals to examine trends in postlaunch prices over time for orally administered anticancer drugs recently approved by the Food and Drug Administration (FDA). In the period 2007-13, inflation-adjusted per patient monthly drug prices increased 5 percent each year. Certain market changes also played a role, with prices rising an additional 10 percent with each supplemental indication approved by the FDA and declining 2 percent with the FDA's approval of a competitor drug. Our findings suggest that there is currently little competitive pressure in the oral anticancer drug market. Policy makers who wish to reduce the costs of anticancer drugs should consider implementing policies that affect prices not only at launch but also later. Project HOPE—The People-to-People Health Foundation, Inc.
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Drought Resilience and Water Conservation Technical Brief
In many areas of the US, the frequency, intensity, and duration of drought events are increasing, this brief highlights EPA drought and conservation activities across the nation and includes links to additional materials and reference documents.
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2013-2014 National Health Law Moot Court Competition Best Brief.
Robinson DeShon, Jessica; Jackson, Brandon; Ward, Matthew
2014-01-01
This document was judged Best Brief submitted to the 2013–2014 National Health Law Moot Court Competition. The brief was submitted by students Jessica Robinson DeShon, Brandon Jackson, and Matthew Ward on behalf of Faulkner University School of Law in Montgomery, Alabama. Address correspondence to Professor Joe Lester at Jlester@Faulkner.edu.
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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-2009-D-0260] Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic... Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-23
... Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice... document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that... approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the...
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Radhakrishnan, Krishna; Tripathy, Jasaswini; Raichur, Ashok M
2013-06-14
Hollow microcapsules capable of disintegrating in response to dual biological stimuli have been synthesized from two FDA approved drug molecules. The capsules fabricated from protamine and chondroitin sulphate disintegrate in the presence of either trypsin or hyaluronidase enzymes, which are documented to be simultaneously over-expressed under some pathological conditions.
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ERIC Educational Resources Information Center
Elliot, Norbert; Haggerty, Blake; Foster, Mary; Spak, Gale
2008-01-01
The present study documents the results of a 17-month program to train Cardinal Health Pharmaceutical Technology Services (PTS) employees in an innovative model that combines investigative and writing techniques. Designed to address the Code of Federal Regulations (CFR) for the United States Food and Drug Administration (FDA), the program is a…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH... submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-20
... Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this... search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html... CDRH and CBER are implementing this provision of the law and providing public notice as required. The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-25
... for Devices and Radiological Health (CDRH) Food and Drug Administration, 10903 New Hampshire Ave...''). This guidance is intended to provide the current thinking of CDRH and CBER on when IVD products are... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device...
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FDA Benchmark Medical Device Flow Models for CFD Validation.
Malinauskas, Richard A; Hariharan, Prasanna; Day, Steven W; Herbertson, Luke H; Buesen, Martin; Steinseifer, Ulrich; Aycock, Kenneth I; Good, Bryan C; Deutsch, Steven; Manning, Keefe B; Craven, Brent A
Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent groups to assess current CFD techniques. The primary goal of this article is to summarize the FDA initiative and to report recent findings from the benchmark blood pump model study. Discrepancies between CFD predicted velocities and those measured using particle image velocimetry most often occurred in regions of flow separation (e.g., downstream of the nozzle throat, and in the pump exit diffuser). For the six pump test conditions, 57% of the CFD predictions of pressure head were within one standard deviation of the mean measured values. Notably, only 37% of all CFD submissions contained hemolysis predictions. This project aided in the development of an FDA Guidance Document on factors to consider when reporting computational studies in medical device regulatory submissions. There is an accompanying podcast available for this article. Please visit the journal's Web site (www.asaiojournal.com) to listen.
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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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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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Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E
Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001). Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.
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Vivot, A; Jacot, J; Zeitoun, J-D; Ravaud, P; Crequit, P; Porcher, R
2017-05-01
Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems. The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit. Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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This research brief was developed by EPA's Risk Reduction Engineering Laboratory , Cincinnati, OH, to announce key findings of the research projects that are fully documented in separate reports and journal articles.
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Tanning lamps: health effects and reclassification by the Food and Drug Administration.
Ernst, Alexander; Grimm, Amanda; Lim, Henry W
2015-01-01
Tanning lamps have long been considered a class I medical device under regulation by the Food and Drug Administration (FDA). A growing body of research has repeatedly documented the association between elective indoor tanning and several negative health consequences. These accepted findings have prompted action by the FDA to officially reclassify tanning lamps as a class II medical device. The main purpose of this review is to update practitioners on the current state of tanning lamp classification and highlight the practical implications of this recent change. This information can be used by clinicians to easily reference this important action, and empower patients with a better understanding of the risks associated with indoor tanning. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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Fibrin sealants: surgical hemostat, sealant and adhesive.
Mandell, Samuel P; Gibran, Nicole S
2014-06-01
Fibrin sealants (FS) have been approved for use in the United States since 1998. Since approval, they have been used in a wide variety of clinical settings and new products continue to be introduced. This review covers the literature supporting the USA FDA-approved indications for FS products produced by Baxter Corp. Literature review of PubMed, the Cochrane Library, FDA approval documents and product websites yielded information contained in this article. Mechanism of action, efficacy and safety of these products are covered. FS are generally safe, popular and are used for a wide variety of off-label indications. Their use appears to be expanding rapidly. For many uses, including approved ones, large well-controlled trials are still needed. Additionally, cost-effectiveness data for these products would be a great benefit in guiding their future use.
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Designing Flightdeck Procedures
NASA Technical Reports Server (NTRS)
Barshi, Immanuel; Mauro, Robert; Degani, Asaf; Loukopoulou, Loukia
2016-01-01
The primary goal of this document is to provide guidance on how to design, implement, and evaluate flight deck procedures. It provides a process for developing procedures that meet clear and specific requirements. This document provides a brief overview of: 1) the requirements for procedures, 2) a process for the design of procedures, and 3) a process for the design of checklists. The brief overview is followed by amplified procedures that follow the above steps and provide details for the proper design, implementation and evaluation of good flight deck procedures and checklists.
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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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Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T
2017-04-01
Objective The US Food and Drug Administration (FDA) approves indications for prescription drugs based on premarket pivotal clinical studies designed to demonstrate safety and efficacy. We characterized the pivotal studies supporting FDA approval of otolaryngologic prescription drug indications. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects Recently approved (2005-2014) prescription drug indications for conditions treated by otolaryngologists or their multidisciplinary teams. Drugs could be authorized for treatment of otolaryngologic disease upon initial approval (original indications) or thereafter via supplemental applications (supplemental indications). Methods Pivotal studies were categorized by enrollment, randomization, blinding, comparator type, and primary endpoint. Results Between 2005 and 2014, the FDA approved 48 otolaryngologic prescription drug indications based on 64 pivotal studies, including 21 original indications (19 drugs, 31 studies) and 27 supplemental indications (18 drugs, 33 studies). Median enrollment was 299 patients (interquartile range, 198-613) for original indications and 197 patients (interquartile range, 64-442) for supplemental indications. Most indications were supported by ≥1 randomized study (original: 20/21 [95%], supplemental: 21/27 [78%]) and ≥1 double-blinded study (original: 14/21 [67%], supplemental: 17/27 [63%]). About half of original indications (9/21 [43%]) and one-quarter of supplemental indications (7/27 [26%]) were supported by ≥1 active-controlled study. Nearly half (original: 8/21 [38%], supplemental: 14/27 [52%]) of all indications were approved based exclusively on studies using surrogate markers as primary endpoints. Conclusion The quality of clinical evidence supporting FDA approval of otolaryngologic prescription drug indications varied widely. Otolaryngologists should consider limitations in premarket evidence when helping patients make informed treatment decisions about newly approved drugs.
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Protocol for selecting ASR-affected structures for lithium treatment
DOT National Transportation Integrated Search
2006-02-01
This TechBrief describes a protocol for evaluating damaged concrete structures to determine whether they are suitable candidates for lithium treatment to address alkali-silica reactivity (ASR). A major part of the TechBrief's source document, Protoco...
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Please note: The documents below have been translated into ...
Center for Food Safety and Applied Nutrition (CFSAN)
... 法律规定，不是针对该国主管部门食品安全体系 的系统审查。 ... 信息。请查看以下 网站 了解更多有关 FDA 如何与厂家管理 层召开结束 会议 的信息： ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-02
... Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research... CDRH and CBER and have been compiled into checklists for use by FDA review staff. In the Federal... do so by using the Internet. A search capability for all CDRH guidance documents is available at http...
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ERIC Educational Resources Information Center
National Governors' Association, Washington, DC.
This document presents briefing papers for the seven gubernatorial task forces proposed in the National Governors' Association Action Plan for Attaining Educational Excellence. An introductory section discusses the complementary responsibilities of Federal, State, and local governments for assuring access to educational opportunities for all…
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Phase II Study Proposal Briefs.
ERIC Educational Resources Information Center
National Center for the Study of Postsecondary Educational Supports, Honolulu, HI.
This document collects 23 study proposal briefs presented to the National Center for the Study of Postsecondary Educational Supports. The proposals address the following topics concerned with postsecondary services for students with disabilities: cultural empowerment, longitudinal analysis of postsecondary students' experience, effective models of…
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GATEWAY Report Brief: SSL Demonstration: Long-Term Evaluation of Indoor Field Performance
DOE Office of Scientific and Technical Information (OSTI.GOV)
None, None
Report brief summarizing a GATEWAY program evaluation of the long-term performance characteristics (chromaticity change, maintained illuminance, and operations and maintenance) of LED lighting systems in four field installations previously documented in separate DOE GATEWAY reports.
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Trivedi, Madhukar H; Wisniewski, Stephen R; Morris, David W; Fava, Maurizio; Kurian, Benji T; Gollan, Jackie K; Nierenberg, Andrew A; Warden, Diane; Gaynes, Bradley N; Luther, James F; Rush, A John
2011-06-01
US Food and Drug Administration (FDA) warnings recommend monitoring negative symptoms associated with the initiation of antidepressant medications as these symptoms may interfere with full recovery and pose safety concerns. There is currently no brief, reliable rating instrument for assessing treatment-emergent, negative symptoms. We evaluated the psychometric properties of 2 versions of the newly developed 17-item Concise Associated Symptom Tracking (CAST) scale, the CAST Clinician Rating (CAST-C) and CAST Self-Rated (CAST-SR), which are brief instruments designed to measure the 5 relevant associated symptom domains (irritability, anxiety, mania, insomnia, and panic). The study enrolled 265 outpatients with major depressive disorder (MDD), from July 2007 through February 2008, into an 8-week, open-label trial with a selective serotonin reuptake inhibitor. Diagnosis of MDD was determined by the Psychiatric Diagnostic Screening questionnaire and an MDD checklist based on DSM-IV-TR criteria. Suicidality (suicidal ideation with associated behaviors) is 1 of 9 symptoms of MDD (depressed mood, loss of interest, appetite or weight change, sleep disturbance, reduced concentration or indecisiveness, fatigue or decreased energy, psychomotor agitation or retardation, feelings of worthlessness or excessive guilt). Psychometric evaluations were conducted on both versions of the CAST. Cronbach α was .80 (CAST-C) and .81 (CAST-SR). Factor analysis identified 5 factors for each scale: (1) irritability, (2) anxiety, (3) mania, (4) insomnia, and (5) panic. When the item that cross-loaded on 2 factors was eliminated, the 16-item solution had a better goodness of fit (CAST-C: 0.90 vs 0.87; CAST-SR: 0.88 vs 0.84). Cronbach α for the 16-item versions was .77 (CAST-C) and .78 (CAST-SR). The 5 associated CAST symptom domains correlated well with other standard measures of these domains. The 16-item CAST-C and CAST-SR demonstrated excellent psychometric properties. These are potentially useful measures for monitoring treatment-emergent negative symptoms associated with antidepressants, as recommended by the FDA. Clinicaltrials.gov Identifier: NCT00532103. © Copyright 2011 Physicians Postgraduate Press, Inc.
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JCL roundtable: Risk evaluation and mitigation strategy.
Brown, W Virgil; Bramlet, Dean A; Ross, Joyce L; Underberg, James A
Many factors enter into the decision by the Food and Drug Administration (FDA) to approve a new drug for use by physicians and other health care providers in treating diseases. Initially, the FDA authority was restricted to issues of safety and only later did the documentation of efficacy become part of the review process required for approval. However, all drugs have the potential for causing harm at some dose level to all and at lower doses in certain patients with vulnerability to the particular pharmacology of the agent. As new drugs have been designed to manage disorders that are uncommon, but of significant consequence, they may have adverse effects that are acceptable only because they are so uniquely beneficial to these specific conditions. The risk of these adverse effects may be acceptable since the benefit can outweigh the harm in most patients and the adversity can be predicted and managed. The approval of this category of drugs has grown rapidly since definition of a mechanism of action to manage and modify the risk has been provided by a process known as known as Risk Evaluation and Mitigation Strategy or "REMS." In 2007, the Food and Drug Administration Amendments Act (FDAAA) allowed the FDA to require postmarketing studies and the authority to mandate the implementation of a REMS for drugs with efficacy but documented potential for harm. Two relatively new drugs useful in the management of severe elevations of low-density lipoprotein cholesterol have been approved under a requirement for a REMS. These are lomitapide, an inhibitor of microsomal triglyceride transfer protein and mipomersen, an antisense oligonucleotide which reduces the synthesis of apolipoprotein B. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.
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Documenting Collective Development in Online Settings
ERIC Educational Resources Information Center
Dean, Chrystal; Silverman, Jason
2015-01-01
In this paper the authors explored the question of collective understanding in online mathematics education settings and presented a brief overview of traditional methods for documenting norms and collective mathematical practices. A method for documenting collective development was proposed that builds on existing methods and frameworks yet is…
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14 CFR 302.3 - Filing of documents.
Code of Federal Regulations, 2010 CFR
2010-01-01
... set at the DOT Dockets Management System (DMS) internet website. (2) Such documents will be deemed to... as to the contents and style of briefs. (2) Papers may be reproduced by any duplicating process...
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Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai
2017-01-01
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.
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Gene therapy for cancer: regulatory considerations for approval.
Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K
2015-12-01
The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.
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Radiation countermeasure agents: an update (2011 – 2014)
Newman, Victoria L; Romaine, Patricia LP; Wise, Stephen Y; Seed, Thomas M
2014-01-01
Introduction Despite significant scientific advances over the past 60 years towards the development of a safe, nontoxic and effective radiation countermeasure for the acute radiation syndrome (ARS), no drug has been approved by the US FDA. A radiation countermeasure to protect the population at large from the effects of lethal radiation exposure remains a significant unmet medical need of the US citizenry and, thus, has been recognized as a high priority area by the government. Area covered This article reviews relevant publications and patents for recent developments and progress for potential ARS treatments in the area of radiation countermeasures. Emphasis is placed on the advanced development of existing agents since 2011 and new agents identified as radiation countermeasure for ARS during this period. Expert opinion A number of promising radiation countermeasures are currently under development, seven of which have received US FDA investigational new drug status for clinical investigation. Four of these agents, CBLB502, Ex-RAD, HemaMax and OrbeShield, are progressing with large animal studies and clinical trials. G-CSF has high potential and well-documented therapeutic effects in countering myelosuppression and may receive full licensing approval by the US FDA in the future. PMID:25315070
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Gene therapy for cancer: regulatory considerations for approval
Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K
2015-01-01
The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA. PMID:26584531
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Using Gestalt Theory to Teach Document Design and Graphics.
ERIC Educational Resources Information Center
Moore, Patrick; Fitz, Chad
1993-01-01
Presents a brief overview of Gestalt theory. Discusses and illustrates six key principles of Gestalt psychology as they apply to document design and graphics. Presents exercise that students may use to improve their understanding of the principles and develop their document design skills. Distinguishes between Gestalt theory and rhetoric. (RS)
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Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S
2015-08-11
The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.
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Morimoto, Kazushige; Kawasaki, Satoko; Yoshida, Yasunori
2015-01-01
For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.
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NASA Technical Reports Server (NTRS)
Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.
2007-01-01
Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.
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Ferkany, John W; Williams, Michael
2008-09-01
Translational biomedical research is often directed to the introduction of a new drug or biologic intended to treat unmet medical need in humans. This unit describes the timing and content of the investigational new drug (IND) application, the primary document required by the U.S. FDA for the initiation of clinical trials in humans with any new chemical entity (NCE) or biologic. The IND application contains all the information necessary for the FDA to make an assessment of the risks and benefits of the proposed clinical trials for the NCE/biologic, containing a detailed but succinct description of the biology, safety, toxicology, chemistry and manufacturing process, and the proposed clinical plan. This unit is geared for those with little or no experience with the IND process and is intended as a global introduction to this, the initial stage of the drug development process for drugs used in humans.
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Finance issue brief: medical necessity: year end report-2003.
MacEachern, Lillian
2003-12-31
The information in this issue brief is based on a 50--state survey and a recent literature review. The Health Policy Tracking Service recognizes the complexity of this issue and discourages the use of this document as a sole resource on the issue.
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Finance issue brief: medical necessity: year end report-2002.
Morgan, Rachel; MacEachern, Lillian
2002-12-31
The information in this issue brief is based on a 50--state survey and a recent literature review. The Health Policy Tracking Service recognizes the complexity of this issue and discourages the use of this document as a sole resource on the issue.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-29
... request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device... Responses Response Total hours CDRH 3601 110 1 110 2 220 CBER 3601 4 1 4 2 8 Total Hours 228 \\1\\ There are...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-17
... Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver... request, or fax your request to CDRH at 301-847-8149. The draft guidance may also be obtained by mail by... using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda...
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Briefing Number 3 to Space Station Operations Task Force Oversight Committee
NASA Technical Reports Server (NTRS)
Lyman, Peter; Shelley, Carl
1987-01-01
This document reviews certain issues in relationship to the operation of the Space Station Freedom. The document is in outline format and includes some organizational hierarchy charts, pert charts and decision charts.
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DATAS Hardware Diagnostic Tests
DOT National Transportation Integrated Search
1990-10-01
This document is reference material for personnel using the Data Link and : Analysis System (DATAS) for hardware diagnostic testing. Included in this : document is a brief overall description of the DATAS, and a thorough : description of how to opera...
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Moore, Thomas J; Furberg, Curt D
2014-01-01
The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.
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Adusumilli, Prasad S; Cha, Edward; Cornfeld, Mark; Davis, Thomas; Diab, Adi; Dubensky, Thomas W; Evans, Elizabeth; Grogan, Jane L; Irving, Bryan A; Leidner, Rom S; Olwill, Shane A; Soon-Shiong, Patrick; Triebel, Frederic; Tuck, David; Bot, Adrian; Dansey, Roger D; Drake, Charles G; Freeman, Gordon J; Ibrahim, Ramy; Patel, Salil; Chen, Daniel S
2017-01-01
This report is a summary of 'New Cancer Immunotherapy Agents in Development' program, which took place in association with the 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC), on November 9, 2016 in National Harbor, Maryland. Presenters gave brief overviews of emerging clinical and pre-clinical immune-based agents and combinations, before participating in an extended panel discussion with multidisciplinary leaders, including members of the FDA, leading academic institutions and industrial drug developers, to consider topics relevant to the future of cancer immunotherapy.
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AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.
2017-01-01
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients, health economists, academia, and others. The multistakeholder group represented the key professionals and entities affected by the federal laws and FDA regulations that restrict the sharing of preapproval information and the collective credibility necessary for proposing this new communication process. Forum participants primarily focused on 6 items of discussion: (1) creating and defining new terms for how biopharmaceutical manufacturers may provide clinical and economic information 12-18 months before FDA approval; (2) defining the clinical and scientific standards that this information should meet; (3) determining which entities should have access to this information and the value to each; (4) the format and process by which this information should be disseminated; (5) developing definitions for existing terms referenced in current laws, regulations, or guidance documents that would need to be modernized to align with the identified new term; and (6) providing safeguards to prevent this information from reaching unintended entities. Forum participants selected "preapproval information exchange" (PIE) as the correct term to describe this proposed new communication process and to be inclusive of data from pivotal phase III clinical trials, pharmaco-economic data, and patient-reported outcomes, as well as other relevant items, including anticipated indications, place in therapy, and routes of administration. Stakeholders agreed that PIE should be truthful, non-misleading, and include a broad range of information to meet the needs of population health decision makers and health care technology evolution. Recipients of PIE would be limited to population health decision makers who need this information for coverage decisions. The format and process for PIE disseminated should allow for a bidirectional exchange between manufacturers and population health decision makers but should not be proscribed in legislation. Furthermore, new legislative language may be beneficial, since PIE is a novel category of information. New legislation could provide a safe harbor and clarity that PIE does not violate preapproval promotion and the Federal Food, Drug, and Cosmetic Act and its regulations. The AMCP Partnership Forum on Enabling the Exchange of Clinical and Economic Data Pre-FDA Approval and the development of this proceedings document were supported by AbbVie, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Celgene, Intarcia Therapeutics, Eli Lilly and Company, GlaxoSmithKline, Merck, National Pharmaceutical Council, Novo Nordisk, Pfizer, Pharmaceutical Research and Manufacturers of America, Precision for Value, Sanofi, Takeda Pharmaceuticals, U.S.A., and Xcenda. All sponsors participated in the forum and in revising and approving the manuscript.
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Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor
2014-05-01
The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
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Kraus, Carl N; Baldwin, Alan T; McAllister, R G
2013-02-01
The US Food and Drug Administration (FDA) requires risk communication as an element of Risk Evaluation and Mitigation Strategies (REMS) to alert and educate healthcare providers about severe toxicities associated with approved drugs. The educational effectiveness of this approach has not been evaluated. To support the communication plan element of the ipilimumab REMS, a Medscape Safe Use Alert (SUA) letter was distributed by Medscape via email and mobile device distribution to clinicians specified in the REMS. This alert contained the FDA-approved Dear Healthcare Provider (DHCP) letter mandated for distribution. A continuing medical education (CME) activity describing ipilimumab toxicities and the appropriate management was simultaneously posted on the website and distributed to Medscape members. Data were collected over a 6-month period regarding the handling of the letter and the responses to pre- and post-test questions for those who participated in the CME activity. Analysis of the answers to the pre- and posttest questions showed that participation in the CME activity resulted in an improvement in correct answer responses of 47%. Our experience shows that there are likely distinct information sources that are utilized by different HCP groups. The ready availability of a brief CME activity was utilized by 24,063 individuals, the majority of whom showed enhanced understanding of ipilimumab toxicity by improvement in post-test scores, educational data that are not available via implementation of standard safety alert communications. These results demonstrate that improvement in understanding of specific drug toxicities is enhanced by a CME intervention.
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Publication Production: An Annotated Bibliography.
ERIC Educational Resources Information Center
Firman, Anthony H.
1994-01-01
Offers brief annotations of 52 articles and papers on document production (from the Society for Technical Communication's journal and proceedings) on 9 topics: information processing, document design, using color, typography, tables, illustrations, photography, printing and binding, and production management. (SR)
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Wisconsin Response to Intervention: A Guiding Document
ERIC Educational Resources Information Center
Wisconsin Department of Public Instruction, 2010
2010-01-01
To assist Wisconsin education leaders with planning for Response to Intervention (RtI), the Wisconsin Department of Public Instruction (DPI), in partnership with Wisconsin education stakeholders, has developed this informational brief. This brief is intended to provide guidance for implementation of RtI and should not be read as administrative…
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A Brief Introduction to Foreign Languages Education Policy in China
ERIC Educational Resources Information Center
Zhang, Weiwen
2012-01-01
Based on a series of official published documents and relevant research reports, the paper make a brief introduction to foreign languages education policies in China, which included national English teaching guidance, national English language textbooks, national English curriculum standard and the massive English teachers training program, etc.…
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A Brief History of the Flathead Tribes.
ERIC Educational Resources Information Center
Woodcock, Clarence; And Others
A source document, illustrated with many black and white photographs of tribe members and activities, provides a brief history of the American Indian tribes, now called the Flatheads, living on the Flathead Indian Reservation in Montana and describes some of their cultural traditions, particularly their ceremonial dances. The booklet traces the…
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The EDUTECH Report, 2002-2003.
ERIC Educational Resources Information Center
Warger, Thomas, Ed.
2003-01-01
This document consists of 12 issues, an entire volume year, of "The EDUTECH Report." The newsletter's purpose is to alert faculty and administrators to issues in educational technology. Each issue contains two feature articles, a page of news briefs, and a question and answer column. Most issues also contain brief quotations on education…
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The EDUTECH Report, 2001-2002.
ERIC Educational Resources Information Center
Warger, Thomas, Ed.
2002-01-01
This document consists of 12 issues of the "EDUTECH Report." The newsletter's purpose is to alert faculty and administrators to issues in educational technology. Each issue contains two feature articles, a page of news briefs, and a question and answer column. Issues also contain brief quotations on education technology topics. The…
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DOT National Transportation Integrated Search
2014-04-01
This Analysis Brief documents the methodology and results from the Compliance Review Effectiveness Model (CREM) for carriers receiving CRs in fiscal year (FY) 2009. The model measures the effectiveness of the compliance review (CR) program, one of th...
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Improving access to skilled attendance at delivery: a policy brief for Uganda.
Nabudere, Harriet; Asiimwe, Delius; Amandua, Jacinto
2013-04-01
This study describes the process of production, findings for a policy brief on Increasing Access to Skilled Birth Attendance, and subsequent use of the report by policy makers and others from the health sector in Uganda. The methods used to prepare the policy brief use the SUPPORT Tools for evidence-informed health policy making. The problem that this evidence brief addresses was identified through an explicit priority setting process involving policy makers and other stakeholders, further clarification with key informant interviews of relevant policy makers, and review of relevant documents. A working group of national stakeholder representatives and external reviewers commented on and contributed to successive drafts of the report. Research describing the problem, policy options, and implementation considerations was identified by reviewing government documents, routinely collected data, electronic literature searches, contact with key informants, and reviewing the reference lists of relevant documents that were retrieved. The proportion of pregnant women delivering from public and private non-profit facilities was low at 34 percent in 2008/09. The three policy options discussed in the report could be adopted independently or complementary to the other to increase access to skilled care. The Ministry of Health in deliberating to provide intrapartum care at first level health facilities from the second level of care, requested for research evidence to support these decisions. Maternal waiting shelters and working with the private-for-profit sector to facilitate deliveries in health facilities are promising complementary interventions that have been piloted in both the public and private health sector. A combination of strategies is needed to effectively implement the proposed options as discussed further in this article. The policy brief report was used as a background document for two stakeholder dialogue meetings involving members of parliament, policy makers, health managers, researchers, civil society, professional organizations, and the media.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-02
... costs to total FDA costs of the review of human generic drug activities for the first 3 of the preceding... review of human generic drug activities. Since the first year of the Generic Drug User Fee Program has... activities other than PC&B (see section 744B(c)(1)(C) of the FD&C Act). Table 3 of this document provides the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-19
...The Food and Drug Administration (FDA) is announcing the reorganization of the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This notice was previously published in the Federal Register of August 18, 2009, but it contained several errors. For the convenience of the reader, the reorganization is being published again in its entirety.
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Increased importance of the documented development stage in process validation.
Mohammed-Ziegler, Ildikó; Medgyesi, Ildikó
2012-07-01
Current trends in pharmaceutical quality assurance moved when the Federal Drug Administration (FDA) of the USA published its new guideline on process validation in 2011. This guidance introduced the lifecycle approach of process validation. In this short communication some typical changes from the point of view of practice of API production are addressed in the light of inspection experiences. Some details are compared with the European regulations.
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Mission Connect Mild TBI Translational Research Consortium
2010-08-31
symptoms are known to be associated with the study drug, atorvastatin , and they are listed in the Informed Consent document. In this second year of the...confirm that atorvastatin (see note below) given during the acute phase of MTBI has no adverse effects in patients with MTBI NOTE: Due to an...FDA hold on all human studies involving erythropoietin, the neuroprotective agent for this phase II clinical trial was changed to atorvastatin
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Open Source Patient-Controlled Analgesic Pump Requirements Documentation
Larson, Brian R.; Hatcliff, John; Chalin, Patrice
2014-01-01
The dynamic nature of the medical domain is driving a need for continuous innovation and improvement in techniques for developing and assuring medical devices. Unfortunately, research in academia and communication between academics, industrial engineers, and regulatory authorities is hampered by the lack of realistic non-proprietary development artifacts for medical devices. In this paper, we give an overview of a detailed requirements document for a Patient-Controlled Analgesic (PCA) pump developed under the US NSF’s Food and Drug Administration (FDA) Scholar-in-Residence (SIR) program. This 60+ page document follows the methodology outlined in the US Federal Aviation Administrations (FAA) Requirements Engineering Management Handbook (REMH) and includes a domain overview, use cases, statements of safety & security requirements, and formal top-level system architectural description. Based on previous experience with release of a requirements document for a cardiac pacemaker that spawned a number of research and pedagogical activities, we believe that the described PCA requirements document can be an important research enabler within the formal methods and software engineering communities. PMID:24931440
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An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making
Abedtash, Hamed; Duke, Jon D.
2015-01-01
FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the ‘signal-to-noise ratio’ and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label. PMID:26958158
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An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making.
Abedtash, Hamed; Duke, Jon D
FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the 'signal-to-noise ratio' and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label.
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Joffe, Hylton V; Parks, Mary H; Temple, Robert
2010-03-01
All medications currently approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus are indicated to improve glycemic control. Since 1995, FDA has used HbA1c as the primary basis for approval of these therapies because a reduction in blood glucose lessens the symptoms of hyperglycemia and lowering of HbA1c has been shown to reduce the risk for some of the chronic complications of diabetes. Despite evidence of clinical benefit with therapies that reduce HbA1c, concerns have been raised that some diabetes medications may increase cardiovascular risk in a patient population that is already vulnerable to cardiovascular disease. Therefore, FDA convened a public advisory committee meeting to discuss the role of cardiovascular assessment in the pre-approval and post-approval settings for medications developed for the treatment of type 2 diabetes. After considering the advisory panel's recommendations and other data, FDA published a guidance document requesting evidence showing that new treatments for type 2 diabetes do not result in an unacceptable increase in cardiovascular risk. This review article begins by summarizing the events leading up to publication of this guidance. Subsequent sections discuss the guidance itself as well as general considerations for implementing the new cardiovascular recommendations. The new approach to developing medications for the treatment of type 2 diabetes will lead to evaluation in patients more representative of those who will use these therapies, if approved, and will help healthcare providers make informed decisions when choosing a medication within the growing treatment armamentarium for type 2 diabetes.
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Lowe, Gregory; Costabile, Raymond A
2012-01-01
To ensure public safety all Food and Drug Administration (FDA)-approved medications undergo postapproval safety analysis. Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and effective. We performed a nonindustry-sponsored analysis of FDA reports for sildenafil, tadalafil, and vardenafil to evaluate the reported cardiovascular and mortality events over the past 10 years. Summarized reports of adverse events (AEs) for each PDE5-i were requested from the Center for Drug Evaluation and Research within the FDA. These data are available under the Freedom of Information Act and document industry and nonindustry reports of AEs entered into the computerized system maintained by the Office of Surveillance and Epidemiology. The data were analyzed for the number of AE reports, number of objective cardiovascular events, and reported deaths. Overall, 14,818 AEs were reported for sildenafil. There were 1,824 (12.3%) reported deaths, and reports of cardiovascular AEs numbered 2,406 (16.2%). Tadalafil was associated with 5,548 AEs and 236 deaths were reported. Vardenafil was associated with 6,085 AEs and 121 reports of deaths. The percentage of reported severe cardiovascular disorders has stabilized at 10% to 15% of all AE reports for sildenafil and tadalafil and 5% to 10% for vardenafil. Only 10% of AE reports sent to the FDA for PDE5-i were from pharmaceutical manufacturers. Reports of deaths associated with PDE5-i remain around 5% of total reported events. Despite inherent limitations from evaluating FDA reports of AEs, it is important that these reports be reviewed outside pharmaceutical industry support in order to provide due diligence and transparency. Lowe G and Costabile RA. 10-year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. J Sex Med 2012;9:265-270. © 2011 International Society for Sexual Medicine.
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Mulinari, Shai; Davis, Courtney
2017-11-09
Relenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs. We conducted a qualitative analysis of United States and European Union regulatory appraisals for Relenza to investigate the reasons for divergent regulatory interpretations, pertaining to Relenza's capacity to alleviate symptoms and reduce frequency of complications of influenza. In Europe, Relenza was evaluated via the so-called national procedure with Sweden as the reference country. We show that FDA reviewers, unlike their European (i.e. Swedish) counterpart, (1) rejected the manufacturer's insistence on pooling efficacy data, (2) remained wary of subgroup analyses, and (3) insisted on stringent statistical analyses. These differences meant that the FDA was less likely to depart from prevailing regulatory and scientific standards in interpreting trial results. We argue that the differences are explained largely by divergent institutionalised review methodologies, i.e. the European regulator's reliance on manufacturer-compiled summaries compared to the FDA's examination of original data and documentation from trials. The FDA's more probing and meticulous evaluative methodology allowed its reviewers to develop 'deep' knowledge concerning the clinical and statistical facets of trials, and more informed opinions regarding suitable methods for analysing trial results. These findings challenge the current emphasis on evaluating regulatory performance mainly in terms of speed of review. We propose that persistent uncertainty and knowledge deficits regarding NIs could have been ameliorated had regulators engaged in the public debates over the drugs' efficacy and explained their contrasting methodologies and judgments. Regulators use major resources to evaluate drugs, but if regulators' assessments are not effectively disseminated and used, resources are used inefficiently.
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A Feature Mining Based Approach for the Classification of Text Documents into Disjoint Classes.
ERIC Educational Resources Information Center
Nieto Sanchez, Salvador; Triantaphyllou, Evangelos; Kraft, Donald
2002-01-01
Proposes a new approach for classifying text documents into two disjoint classes. Highlights include a brief overview of document clustering; a data mining approach called the One Clause at a Time (OCAT) algorithm which is based on mathematical logic; vector space model (VSM); and comparing the OCAT to the VSM. (Author/LRW)
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VET in Schools, 2006: Terms and Definitions. Support Document
ERIC Educational Resources Information Center
National Centre for Vocational Education Research (NCVER), 2008
2008-01-01
This document covers the data terms used in the "VET in Schools, 2006" report. The primary purpose of this document is to help users understand the specific data terms used in the report. Terms that appear in the report are listed in alphabetical order with the following information provided for each: (1) Definition: a brief explanation…
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2006-10-11
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.
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2006-01-01
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006. PMID:17034633
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Effects of a Brief Video Intervention on White University Students' Racial Attitudes
ERIC Educational Resources Information Center
Soble, Jason R.; Spanierman, Lisa B.; Liao, Hsin-Ya
2011-01-01
The authors investigated the effects of a brief video intervention on the racial attitudes of White university students. One hundred thirty-eight self-identified White students were randomly assigned to either an experimental condition in which they viewed a video documenting the pervasiveness of institutional racism and White privilege in the…
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Creating Access to Opportunities for Youth in Transition from Foster Care. An AYPF Policy Brief
ERIC Educational Resources Information Center
Russ, Erin; Fryar, Garet
2014-01-01
What happens to youth in foster care when they turn 18? Many face unprecedented challenges like homelessness, lack of financial resources, difficulty accessing educational opportunities, and unemployment. In this issue brief, The American Youth Policy Forum (AYPF) document these challenges and opportunities in three distinct yet overlapping areas…
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10 CFR 2.346 - Authority of the Secretary.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Adjudicatory Hearings § 2.346 Authority of the Secretary. When briefs, motions or other documents are submitted... filing of briefs, motions, or other pleadings, when the schedules differ from those prescribed by the rules of this part or when the rules of this part do not prescribe a schedule; (b) Rule on motions for...
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Children Exposed to Drugs: What Policymakers Can Do. SERVE Policy Brief.
ERIC Educational Resources Information Center
Thomas, Jan
This policy brief addresses the current and future impact of substance abuse by pregnant women on their infants and children. It provides data on incidence estimates in 1985, 1989, 1995, and 2000. Findings of studies in Alabama, Florida, Georgia, Mississippi, North Carolina, and South Carolina provide documentation for varying incidence estimates.…
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ERIC Educational Resources Information Center
Freeman, Rhonda
Although research documents the adverse effects of parental divorce on children, there is little information on clinical intervention for this population. To empirically test the effectiveness and relative contribution of differing treatments, a program of planned, brief (6 weeks) intervention, aimed at altering children's negative attitudes or…
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The EDUTECH Report, 1997-1998.
ERIC Educational Resources Information Center
EDUTECH Report, 1998
1998-01-01
This document consists of 12 issues of the EDUTECH Report. 1998. The newsletter's purpose is to alert faculty and administrators to issues in educational technology. Each issue contains two feature articles, a page of news briefs, a preview of the upcoming issue, and a question and answer column. Most issues also contain brief quotations on…
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Implementing No Child Left Behind in Three States. Research Brief
ERIC Educational Resources Information Center
Stecher, Brian M.; Epstein, Scott; Hamilton, Laura S.; Marsh, Julie A.; Robyn, Abby; McCombs, Jennifer Sloan; Russell, Jennifer; Naftel, Scott
2008-01-01
This research brief describes work done for RAND Education and documented in "Pain and Gain: Implementing No Child Left Behind in Three States, 2004-2006", Brian M. Stecher, Scott Epstein, Laura S. Hamilton, Julie A. Marsh, Abby Robyn, Jennifer Sloan McCombs, Jennifer Russell, and Scott Naftel." The three states discussed are:…
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ERIC Educational Resources Information Center
Happel, Sue; Loeb, Joyce
Although the activities in this unit are designed primarily for students in the intermediate grades, the document's text, illustrations, and bibliographic references are suitable for anyone interested in learning about Africa. Following a brief introduction and map work, the document is arranged into six sections. Section 1 traces Africa's history…
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Bonacci, Janene M; Venci, Jineane V; Gandhi, Mona A
2015-10-01
In January 2014, the US Food and Drug Administration approved tasimelteon (Hetlioz™), a melatonin-receptor agonist for the treatment of non-24-hour sleep-wake disorder. This article provides an overview of the mechanism of action, pharmacokinetic properties, as well as the clinical efficacy, safety, and tolerability of tasimelteon. Relevant information was identified through a comprehensive literature search of several databases using the key words tasimelteon, Non-24-hour Sleep-Wake disorder, Non-24, and melatonin. Further information was obtained from the tasimelteon package insert, fda.gov, clinicaltrials.gov, briefing materials provided by Vanda Pharmaceuticals, and posters from scientific meetings. © The Author(s) 2014.
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Disclosure of information to organ, tissue and eye procurement organizations. Final rule.
2008-11-03
This document adopts, with changes, a Department of Veterans Affairs (VA) interim final rule that implemented provisions of the Veterans Benefits, Health Care, and Information Technology Act of 2006 concerning disclosure of information to organ, tissue and eye procurement organizations. The regulation will provide authority for VA to provide individually-identifiable VA medical records of veterans or dependents of veterans who are deceased or whose death is imminent to representatives of organ procurement organizations, eye banks, and tissue banks to determine whether the patients are suitable potential donors. This document modifies the interim final rule to clarify the definition of "near death" and to correct a grammatical error in the definition of "procurement organization." This document also clarifies that eye bank and tissue bank registration with FDA must have an active status.
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Johnson, Peter C; Bertram, Tim A; Carty, Neal R; Hellman, Kiki B; Tawil, Bill J; Van Dyke, Mark
2014-06-01
The Industry Committee of the Tissue Engineering Regenerative Medicine International Society, Americas Chapter (TERMIS-AM) administered a survey to its membership in 2013 to assess the awareness of science requirements in the U.S. Food and Drug Administration (FDA) regulatory process. One hundred forty-four members responded to the survey. Their occupational and geographical representation was representative of the TERMIS-AM membership as a whole. The survey elicited basic demographic information, the degree to which members were involved in tissue engineering technology development, and their plans for future involvement in such development. The survey then assessed the awareness of general FDA scientific practices as well as specific science requirements for regulatory submissions to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Projects (OCP). The FDA-specific questions in the survey were culled from guidance documents posted on the FDA web site ( www.fda.gov ). One of the answer options was an opt-out clause that enabled survey respondents to claim a lack of sufficient awareness of the topic to answer the question. This enabled the stratification of respondents on the basis of confidence in the topic. Results indicate that across all occupational groups (academic, business, and government) that are represented in the TERMIS-AM membership, the awareness of FDA science requirements varies markedly. Those who performed best were for-profit company employees, consultants, and government employees; while students, professors, and respondents from outside the USA performed least well. Confidence in question topics was associated with increased correctness in responses across all groups, though the association between confidence and the ability to answer correctly was poorest among students and professors. Though 80% of respondents claimed involvement in the development of a tissue engineering technology, their responses were no more correct than those who were not. Among those developing tissue engineering technologies, few are taking advantage of existing standards organizations to strengthen their regulatory submissions. The data suggest that early exposure to regulatory experts would be of value for those seeking to bring their technology to the market. For all groups studied but especially for students and professors, formal initial or continuing education in Regulatory Science should be considered to best support translational tissue engineering research and development. In addition, the involvement of standards development organizations during tissue engineering technology development is strongly recommended.
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Cryogenic adhesives and sealants: Abstracted publications
NASA Technical Reports Server (NTRS)
Williamson, F. R.; Olien, N. A.
1977-01-01
Abstracts of primary documents containing original experimental data on the properties of adhesives and sealants at cryogenic temperatures are presented. The most important references mentioned in each document are cited. In addition, a brief annotation is given for documents considered secondary in nature, such as republications or variations of original reports, progress reports leading to final reports included as primary documents, and experimental data on adhesive properties at temperatures between about 130 K and room temperature.
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National Earthquake Information Center systems overview and integration
Guy, Michelle R.; Patton, John M.; Fee, Jeremy; Hearne, Mike; Martinez, Eric; Ketchum, D.; Worden, Charles; Quitoriano, Vince; Hunter, Edward; Smoczyk, Gregory; Schwarz, Stan
2015-08-18
It is important to note that this document provides a brief introduction to the work of dozens of software developers and IT specialists, spanning in many cases more than a decade. References to significant amounts of supporting documentation, code, and information are supplied within.
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How to Start Intergenerational Programs in Communities.
ERIC Educational Resources Information Center
2002
This document is designed for use by community organizers in creating, developing and maintaining an intergenerational program. Starting with a brief overview of the Maryland Intergenerational Coalition, the document describes (in short, bulleted entries) the activities and accomplishments of various intergenerational programs in Maryland, such as…
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Illinois Occupational Skill Standards: Telecommunications Technician Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for workforce preparation program providers, details the Illinois Occupational Skill Standards for programs preparing students for employment in the telecommunications technician occupational cluster. The document begins with a brief overview of the Illinois perspective on occupational skills standards…
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DRI Model of the U.S. Economy -- Model Documentation
1993-01-01
Provides documentation on Data Resources, Inc., DRI Model of the U.S. Economy and the DRI Personal Computer Input/Output Model. It also describes the theoretical basis, structure and functions of both DRI models; and contains brief descriptions of the models and their equations.
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Campaign To Reduce Child Poverty. Progress Report [and] Policy Briefs 1-5.
ERIC Educational Resources Information Center
New Mexico Advocates for Children & Families, Albuquerque.
This document is comprised of a progress report and five policy briefs related to the New Mexico Advocates for Children and Families' Campaign To Reduce Child Poverty. This multi-year initiative educates the public and policymakers about child poverty and promotes public policy changes that would reduce poverty. The progress report presents…
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Machine-Aided Indexing in Practice: An Encounter with Automatic Indexing of the Third Kind.
ERIC Educational Resources Information Center
Klingbiel, Paul H.
This three-part report includes a brief history of the Defense Documentation Center (DDC) with a description of the collections and their accessibility; categorization of automatic indexing into three kinds with a brief description of the DDC system of machine-aided indexing; and an indication of some operational experiences with the system.…
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Preserving Knowledge: The Case for Alkaline Paper. ARL Briefing Package Number 3.
ERIC Educational Resources Information Center
Association of Research Libraries, Washington, DC.
This briefing package consists of a compilation of over 15 papers, fact sheets, and other materials focusing on the use of acid-free papers in books and other publications. The document contains the following: Executive Summary and List of Contents; Some Frequently Asked Questions; "Paper Preservation in Library Collections: Basic Information.…
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Foreign Language Training in the United States Peace Corps.
ERIC Educational Resources Information Center
Kulakow, Allan
This document reports on the foreign language training offered in the Peace Corps. Following a brief introductory statement, a list of languages taught by the Peace Corps in the years 1961-67 is provided, as well as a brief description of Peace Corps language training methods. Guidelines for language coordinators are outlined, and the approach to…
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A Brief History of the Transfer System in British Columbia
ERIC Educational Resources Information Center
Gaber, Devron
2005-01-01
This document presents a brief history of important events in the development and maintenance of the post-secondary transfer system in British Columbia (BC) over the last six decades. Information is presented in point form and in chronological order. Several points related to the expansion of the post-secondary system are included, and hence the…
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ERIC Educational Resources Information Center
Bradbury, Katharine; Burke, Mary A.; Triest, Robert K.
2013-01-01
Foreclosures have well-documented adverse consequences for families living in or owning properties undergoing foreclosure and on surrounding neighborhoods, but they may also have other costs. This policy brief summarizes our research on the impact of mortgage foreclosures on academic performance among Boston public school students. The data show…
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Briefs for Parents in Ready-To-Copy Form: English and Spanish. 1993 Compilation.
ERIC Educational Resources Information Center
Howley, Craig; Cahape, Pat
This document contains English and Spanish versions of six one-page reports for parents. Each brief provides background, suggestions, and sources of further information on educational and child-rearing topics of common interest to parents. Titles are: "The Best and Worst of Times: Support Groups Help" ("Los tiempos mejores y peores: Los grupos…
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47 CFR 14.51 - Specifications as to pleadings, briefs, and other documents; subscription.
Code of Federal Regulations, 2012 CFR
2012-10-01
... other documents; subscription. 14.51 Section 14.51 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL ACCESS TO ADVANCED COMMUNICATIONS SERVICES AND EQUIPMENT BY PEOPLE WITH DISABILITIES Recordkeeping... improper purpose. (d) All proposed orders shall be submitted both as hard copies and on computer disk...
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47 CFR 14.51 - Specifications as to pleadings, briefs, and other documents; subscription.
Code of Federal Regulations, 2014 CFR
2014-10-01
... other documents; subscription. 14.51 Section 14.51 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL ACCESS TO ADVANCED COMMUNICATIONS SERVICES AND EQUIPMENT BY PEOPLE WITH DISABILITIES Recordkeeping... improper purpose. (d) All proposed orders shall be submitted both as hard copies and on computer disk...
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47 CFR 14.51 - Specifications as to pleadings, briefs, and other documents; subscription.
Code of Federal Regulations, 2013 CFR
2013-10-01
... other documents; subscription. 14.51 Section 14.51 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL ACCESS TO ADVANCED COMMUNICATIONS SERVICES AND EQUIPMENT BY PEOPLE WITH DISABILITIES Recordkeeping... improper purpose. (d) All proposed orders shall be submitted both as hard copies and on computer disk...
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Illinois Occupational Skill Standards: Chemical Process Technical Operators.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended for workforce preparation program providers, details the Illinois Occupational Skill Standards for programs preparing students for employment as chemical process technical operators. The document begins with a brief overview of the Illinois perspective on occupational skill standards and credentialing, the process…
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Financing the School Plant. Draft.
ERIC Educational Resources Information Center
King, Dave; Kimbrough, Ted
Thirteen methods of financing school buildings in California are described in this document. A brief introduction reviews recent changes in California school financing, following passage of Proposition 13, and explains the need for new financing methods. For each method, the document provides a description (which also points out limitations),…
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Illinois Occupational Skill Standards. Beef Production Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for workforce preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the beef production cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…
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Field Applicable Method to Reduce Dental Emergencies.
1987-07-31
Washington, D.C., December 7-10, 1981. 3. Antiplaque Effects of SnF2. American Society of Dentistry for Children , Maryland Component, Baltimore, December 10...procedures for reporting its assutrnces given by the soonsor.1 findings to the institution. The documents maintained by toe PORN FDA 1372 taC REVII ON MA’y...Research, 11 (Suppl. 1):262. Klock, B., and Krasse, B. (1977) Microbial and salivary conditions in 9-to 12-year-old children . Scandinavian Journal of Dental
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2011-01-01
Marketing pressures, regulatory policies, clinical guidelines, and consumer demand all affect health care providers' knowledge and use of health-related genetic tests that are sold and/or advertised to consumers. In addition, clinical guidelines, regulatory policies, and educational efforts are needed to promote the informed use of genetic tests that are sold and advertised to consumers and health care providers. A shift in culture regarding the regulation of genetic tests that are sold directly to consumers is suggested: by recent actions taken by the US Food and Drug Administration (FDA), including letters sent to direct-to-consumer (DTC) genetic testing companies stating that their tests meet the definition of medical devices; by public meetings held by the FDA to discuss laboratory developed tests; and by the convening of the Molecular and Clinical Genetics Panel to gather input on scientific issues concerning DTC genetic tests that make medical claims. This review provides a brief overview of DTC advertising and the regulation of pharmaceuticals and genetic tests in the United States. It highlights recent changes in the regulatory culture regarding genetic tests that are sold to consumers, and discusses the impact on health care providers of selling and advertising genetic tests directly to consumers. PMID:22204616
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Myers, Melanie F
2011-12-28
Marketing pressures, regulatory policies, clinical guidelines, and consumer demand all affect health care providers' knowledge and use of health-related genetic tests that are sold and/or advertised to consumers. In addition, clinical guidelines, regulatory policies, and educational efforts are needed to promote the informed use of genetic tests that are sold and advertised to consumers and health care providers. A shift in culture regarding the regulation of genetic tests that are sold directly to consumers is suggested: by recent actions taken by the US Food and Drug Administration (FDA), including letters sent to direct-to-consumer (DTC) genetic testing companies stating that their tests meet the definition of medical devices; by public meetings held by the FDA to discuss laboratory developed tests; and by the convening of the Molecular and Clinical Genetics Panel to gather input on scientific issues concerning DTC genetic tests that make medical claims. This review provides a brief overview of DTC advertising and the regulation of pharmaceuticals and genetic tests in the United States. It highlights recent changes in the regulatory culture regarding genetic tests that are sold to consumers, and discusses the impact on health care providers of selling and advertising genetic tests directly to consumers.
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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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Epstein, Richard A
2011-01-01
The Biologics Price Competition and Innovation Act of 2009 ("Biosimilars Act") is for the field of pharmaceutical products the single most important legislative development since passage of the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"), on which portions of the Biosimilars Act are clearly patterned. Congress revised section 351 of the Public Health Service Act (PHSA) to create a pathway for FDA approval of "biosimilar" biological products. Each biosimilar applicant is required to cite in its application a "reference product" that was approved on the basis of a full application containing testing data and manufacturing information, which is owned and was submitted by another company and much of which constitutes trade secret information subject to constitutional protection. Because the Biosimilars Act authorizes biosimilar applicants to cite these previously approved applications, the implementation of the new legislative scheme raises critical issues under the Fifth Amendment of the Constitution, pursuant to which private property--trade secrets included--may not be taken for public use, without "just compensation." FDA must confront those issues as it implements the scheme set out in the Biosimilars Act. This article will discuss these issues, after providing a brief overview of the Biosimilars Act and a more detailed examination of the law of trade secrets.
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[International trend of guidance for nanomaterial risk assessment].
Hirose, Akihiko
2013-01-01
In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Leimkuhler, B.; Hermans, J.; Skeel, R.D.
A workshop was held on algorithms and parallel implementations for macromolecular dynamics, protein folding, and structural refinement. This document contains abstracts and brief reports from that workshop.
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Report on National Collegiate Alcohol Awareness Week, Fall 1988.
ERIC Educational Resources Information Center
Rapaport, Ross J.
This document presents a report of the education and prevention activities undertaken at Central Michigan University in Mt. Pleasant, Michiagn, during the fall semester of 1988, in recognition of National Collegiate Alcohol Awareness Week (NCAAW). The document begins with a brief review of the university's campus-wide programs, goals, and…
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Automotive Technology. 2002 Revision.
ERIC Educational Resources Information Center
Ohio State Dept. of Education, Columbus. Div. of Career-Technical and Adult Education.
This document examines the origins and content of Ohio's Automobile Technician Training Certification Program, which is designed to improve the quality of training offered at secondary and postsecondary schools throughout Ohio. The document begins with a brief overview of the certification program, which is under the oversight of the Board of the…
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Documenting Progress and Demonstrating Results: Evaluating Local Out-of-School Time Programs.
ERIC Educational Resources Information Center
Little, Priscilla; DuPree, Sharon; Deich, Sharon
A collaborative publication between Harvard Family Research Project and The Finance Project, this brief offers guidance in documenting progress and demonstrating results in local out-of-school-time programs. Following introductory remarks providing a rationale for program evaluation, discussing principles of program evaluation, and clarifying key…
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Illinois Occupational Skill Standards: Clinical Laboratory Science/Biotechnology Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended to serve as a guide for workforce preparation program providers, details the Illinois Occupational Skill Standards for clinical laboratory occupations programs. The document begins with a brief overview of the Illinois perspective on occupational skill standards and credentialing, the process used to develop the…
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Environmental Programs Information: Affecting Kansas Public Schools
ERIC Educational Resources Information Center
Kansas State Department of Education, 2004
2004-01-01
This document provides a brief overview of the environmental issues that affect Kansas public schools. Specific programs that address these problems are included, along with their contact information. This document contains information on the following issues and programs: (1) Department of Health and Environment; (2) air; (3) asbestos; (4)…
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Illinois Occupational Skill Standards: Mechanical Drafting Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the mechanical drafting cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…
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Missouri Comprehensive Outdoor Recreation Plan: Executive Summary.
ERIC Educational Resources Information Center
Missouri State Inter-Agency for Outdoor Recreation, Jefferson.
The document is a summary of the Missouri State Comprehensive Outdoor Recreation Plan, which was designed to provide guidelines for allocation of resources for needed recreation facilities. The plan identifies the present and future needs for outdoor recreation and recommends ways of meeting these needs. This 1967 document provides a brief history…
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Illinois Occupational Skill Standards: Architectural Drafting Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the architectural drafting cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…
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Microenterprise Development: An Employment Option for Welfare Recipients.
ERIC Educational Resources Information Center
Friedman, Pamela
2001-01-01
This document examines microenterprise development as an employment option for Temporary Assistance for Needy Families (TANF) recipients. The document begins with a brief discussion of the feasibility of self-employment as an option for TANF recipients, particularly in a slow economy. The next section answers policy questions pertaining to the…
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Illinois Occupational Skill Standards: In-Store Retailing Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended to serve as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the in-store retailing cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards…
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Illinois Occupational Skill Standards: Entry-Level Truck Driver.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended to serve as a guide for workforce preparation program providers, details the Illinois Occupational Skill Standards for programs preparing students for employment as entry-level truck drivers. The document begins with a brief overview of the Illinois perspective on occupational skill standards and credentialing, the…
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Wisconsin's Drug Laws and Enforcement. Staff Brief 89-1.
ERIC Educational Resources Information Center
Matthias, Mary
This document provides information on current Wisconsin statutes and state-level activities relating to the enforcement of controlled substances laws, including assistance provided to local law enforcement agencies. Part I of this document describes the Uniform Controlled Substances Act as enacted by Wisconsin, other statutes which may be used to…
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Illinois Occupational Skill Standards: Finishing and Distribution Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the finishing and distribution cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards…
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30 CFR 250.490 - Hydrogen sulfide.
Code of Federal Regulations, 2010 CFR
2010-07-01
... mitigate damage to property and the environment caused by H2S. You must follow the requirements of this... documentation do I need? For each individual working on the platform, either: (i) You must have documentation of... respirator; practice in donning and adjusting the assigned respirator; information on the safe briefing areas...
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Illinois Occupational Skill Standards: Imaging/Pre-Press Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the imaging/pre-press cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…
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ERIC Educational Resources Information Center
Purcell, Jennifer W.; Scott, Heather I.; Mixson-Brookshire, Deborah
2017-01-01
Teaching observations are commonly used among educators to document and improve teaching effectiveness. Unfortunately, the necessary protocols and supporting infrastructure are not consistently available for faculty who teach online. This paper presents a brief literature review and reflective narratives of educators representing online education…
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1996-05-01
Systems 17 Motion Bases Upgraded Aero Misc > Contact Info • AMC, Lt Col Letica , Phone (618) 256-5696 L8 Upgrade Flow Plan Advance Planning Briefing...Projected Schedule: FY 05 > Requirement Document: AMMP >• Projected Program Size: ? < $40M > Funding Status/Stability: > POCs: • AMC, Lt Col Letica
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ERIC Educational Resources Information Center
Max, Jeffrey; Glazerman, Steven
2014-01-01
This document represents the technical appendix intended to accompany "Do Disadvantaged Students Get Less Effective Teaching? Key Findings from Recent Institute of Education Sciences Studies. NCEE Evaluation Brief. NCEE 2014-4010." Contents include: (1) Summary of Related, Non-Peer-Reviewed Studies; (2) Methods for Comparing Findings…
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Are Charter Schools Making a Difference? A Study of Student Outcomes in Eight States. Research Brief
ERIC Educational Resources Information Center
Li, Jennifer
2009-01-01
Charter schools do not generally draw the top students from other public schools. Their test-score gains are similar to those of traditional public schools, but they have higher rates of students graduating high school and attending college. [This research brief describes work done for RAND Education documented in Charter Schools in Eight States:…
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ERIC Educational Resources Information Center
Cintas, Holly Lea; Parks, Rebecca; Don, Sarah; Gerber, Lynn
2011-01-01
Content validity and reliability of the Brief Assessment of Motor Function (BAMF) Upper Extremity Gross Motor Scale (UEGMS) were evaluated in this prospective, descriptive study. The UEGMS is one of five BAMF ordinal scales designed for quick documentation of gross, fine, and oral motor skill levels. Designed to be independent of age and…
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ERIC Educational Resources Information Center
Hallgren, Kristin; James-Burdumy, Susanne; Perez-Johnson, Irma
2014-01-01
This brief describes the extent to which states required teacher evaluation policies aligned with the Race to the Top (RTT) initiative as of spring 2012. Although teacher evaluation policies appear to be rapidly evolving, documenting policy requirements in the early years of RTT implementation can help inform policymakers about the pace of policy…
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ERIC Educational Resources Information Center
Woal, S. Theodore; DuVall, Patricia S.
This document consists of two brief articles on career education in elementary school. The first article, "Career Education--The Early Years" by S. Theodore Woal, suggests that elementary school is the time to begin to infuse career education concepts and to correlate and integrate career guidance in the school curriculum. Three activities are…
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Early Childhood Education and Care for Native Hawaiian Children in Hawai'i: A Brief History
ERIC Educational Resources Information Center
Grace, Donna J.; Ku'ulei Serna, Alethea
2013-01-01
This study provides a brief overview of the history of early childhood education and care for Native Hawaiian children in Hawai'i. Data sources include a literature review, examination of archival documents, and interviews with a sample of Native Hawaiian parents and community members. We trace the emergence of outside-the-home early childhood…
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Early Musical Training in Bel Canto Vocal Technique: A Brief History and Philosophy.
ERIC Educational Resources Information Center
Gerstein, Christine Wondolowski
This paper offers a brief history and philosophy of the origins of bel canto vocal style and describes the pedagogical methods used to achieve bel canto ideals in singing. The document discusses the adoption and development of this technique and how it developed over long periods of preparation in the foregoing centuries before the Baroque era.…
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Effective Schooling in Rural Africa Report 3: Case Study Briefs on Rural Schooling.
ERIC Educational Resources Information Center
World Bank, Washington, DC. Human Development Network.
This document contains 20 case study briefs about efforts to improve rural schools and teachers in Africa, Latin America, and Asia. Some reforms focus on a part of the education system or a particular population; others attempt to change the national education system. At least seven programs were begun as an alternative to government schools. Most…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-17
...The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).
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Lapham, Gwen T; Rubinsky, Anna D; Shortreed, Susan M; Hawkins, Eric J; Richards, Julie; Williams, Emily C; Berger, Douglas; Chavez, Laura J; Kivlahan, Daniel R; Bradley, Katharine A
2015-08-01
Performance measures for brief alcohol interventions (BIs) are currently based on provider documentation of BI. However, provider documentation may not be a reliable measure of whether or not patients are offered clinically meaningful BIs. In particular, BI documented with clinical decision support in an electronic medical record (EMR) could appear identical irrespective of the quality of BI provided. We hypothesized that differences in how BI was implemented across health systems could lead to differences in the proportion of documented BI recalled and reported by patients across health systems. Male outpatients with unhealthy alcohol use identified by confidential satisfaction surveys (2009-2012) were assessed for whether they reported receiving BI in the past year (patient-reported BI) and whether they had BI documented in the EMR during the same period (documented BI). We evaluated and compared the prevalence of documented BI to patient-reported BI across 21 VA networks to determine whether documented BI had a variable association with patient-reported BI across the networks. Of 9896 eligible male outpatients with unhealthy alcohol use, 59.0% (95% CI 57.4-60.5%) reported BI (50.4-64.9% across networks) and 37.4% (95% CI 36.0-38.9%) had BI documented in the EMR (28.0-44.2% across networks). Overall, 72.9% (95% CI 70.8-75.5%) of patients with documented BI also reported BI. The association between documented BI and patient-reported BI did not vary across VA networks in adjusted logistic regression models. Performance measures of BI that rely on provider documentation in EMRs appear comparable to patient report for comparing care across VA networks. Published by Elsevier Ireland Ltd.
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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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75 FR 20441 - Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-19
...The Food and Drug Administration (FDA) is announcing the issuance of 10 Emergency Use Authorizations (EUAs) (the Authorizations) several of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA also is announcing an amendment to the EUA for the Centers for Disease Control and Prevention (CDC) Swine Influenza Virus Real-time RT-PCR Detection Panel authorized on April 27, 2009. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the Acting Secretary of the U.S. Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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Impact of illness and its treatment on workplace costs: regulatory and measurement issues.
Greenberg, P E; Birnbaum, H G; Kessler, R C; Morgan, M; Stang, P
2001-01-01
In an attempt to document a broader spectrum of the benefits of their pharmaceutical products, drug companies increasingly seek to include productivity claims in their promotional campaigns. We describe the existing regulatory framework of the Food and Drug Administration (FDA) for considering productivity claims, distinguishing between the traditional "substantial evidence" standard and the "competent and reliable scientific evidence" standard. But the notion of competent and reliable scientific evidence may itself be problematic, even when it is the appropriate regulatory standard, because there exists no consistent measurement approach across diseases, workplaces, jobs, and worker capabilities that is widely accepted in this emerging area of health outcomes research. We examine the various measurement approaches that have been used to quantify the impact of illness and its treatment on workplace productivity, and we describe some of the shortcomings associated with each alternative. This discussion highlights the possible difficulties faced by the FDA in reviewing productivity-based promotional claims. Finally, we suggest possible strategies for furthering this field of investigation.
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Interpersonal psychotherapy for depressed adolescents (IPT-A).
Brunstein-Klomek, Anat; Zalsman, Gil; Mufson, Laura
2007-01-01
Recently the Food and Drug Administration (FDA) published a black box warning on the use of serotonin receptor reuptake inhibitors for adolescent depression. This situation makes the non-pharmacological therapeutic alternatives more relevant than ever before. The aim of this review is to introduce the theoretical formulation, practical application and efficacy studies of Interpersonal Psychotherapy for depressed adolescents (IPT-A). A review is offered of published papers in peer-reviewed journals, books and edited chapters using Medline and PsychInfo publications between 1966 and February 2005. IPT-A is an evidence-based psychotherapy for depressed adolescents in both hospital-based and community outpatient settings. IPT-A is a brief and efficient therapy for adolescent depression. Training programs for child psychologists and psychiatrists are recommended.
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Antisense technology: an emerging platform for cardiovascular disease therapeutics.
Lee, Richard G; Crosby, Jeff; Baker, Brenda F; Graham, Mark J; Crooke, Rosanne M
2013-12-01
Antisense oligonucleotides and small interfering RNAs, which suppress the translation of specific mRNA target proteins, are emerging as important therapeutic modalities for the treatment of cardiovascular disease. Over the last 25 years, the advances in all aspects of antisense technology, as well as a detailed understanding of the mechanism of action of antisense drugs, have enabled their use as therapeutic agents. These advancements culminated in the FDA approval of the first chronically administered cardiovascular antisense therapeutic, mipomersen, which targets hepatic apolipoprotein B mRNA. This review provides a brief history of antisense technology, highlights the progression of mipomersen from preclinical studies to multiple Phase III registration trials, and gives an update on the status of other cardiovascular antisense therapeutics currently in the clinic.
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The Third Reich in Perspective: A Resource Unit for Teachers and Group Leaders.
ERIC Educational Resources Information Center
B'nai B'rith, New York, NY. Anti-Defamation League.
A brief history of the Nazi rise to power and genocide of Jews is contained in this pamphlet. The pamphlet was designed to supplement secondary social studies textbooks when it was found that most texts omit or skim over the treatment of the Jews by the Nazis. The document begins with a brief overview of historical content which the developers…
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ERIC Educational Resources Information Center
Ooms, Theodora; Herendeen, Lisa
The purpose of this policy seminar, one of a series of family impact seminars, was to consider current and proposed policies of the federal government that concern child care. This document provides highlights of presentations by the seminar panelists and a background briefing report prepared before the meeting. The highlights section summarizes:…
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ERIC Educational Resources Information Center
Bellm, Dan
2005-01-01
This policy brief provides guidelines grouped into five areas: personal and professional behavior; classroom environment; health, safety and nutrition; working with families and communities; and administration and management. The document discusses the topics that teacher competencies generally cover, options for how they might be developed and…
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ERIC Educational Resources Information Center
Carson, Jessica A.
2015-01-01
This brief uses data from the 2013 Current Population Survey's Food Security Supplement to document levels of participation in two of the largest programs authorized by the Healthy, Hunger-Free Kids Act of 2010--the National School Lunch Program and the School Breakfast Program--by region and place type (rural, suburban, and city), to identify…
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ERIC Educational Resources Information Center
Goldberger, Susan; Haynes, Leslie
2005-01-01
This document represents the first in a series of design briefs on models for early college high schools. The briefs focus on the academic and organizational design of the college component and tie those key features to a sustainable financing model. By engaging students in up to two years of demanding college-level work while still in high…
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ERIC Educational Resources Information Center
Dembo, Richard; Schmeidler, James; Wareham, Jennifer; Briones-Robinson, Rhissa; Winters, Ken C.; Ungaro, Rocio
2016-01-01
The issue of delinquency among truant youths is insufficiently documented in the literature. There is a need to elucidate this issue, and assess the efficacy of interventions to reduce this problem behavior. The present National Institute on Drug Abuse (NIDA)-funded study addressed this gap by examining the impact of a Brief Intervention (BI),…
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ERIC Educational Resources Information Center
Leos-Urbel, Jacob; Schwartz, Amy Ellen; Weinstein, Meryle; Weitzman, Beth C.
2012-01-01
This policy brief presents initial findings of the impact of New York City's Summer Youth Employment Program (SYEP) on academic outcomes for public school students. Despite the broad appeal of providing summer jobs for urban youth, there is little research documenting the relationship between summer employment and educational outcomes for high…
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An Analysis of the Horticulture Equipment and Services Occupation.
ERIC Educational Resources Information Center
Harbage, Monroe; Lechner, Donald L.
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the horticulture equipment and services occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Fourteen duties are…
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Advanced Marketing/Coop Course Outline.
ERIC Educational Resources Information Center
Dixon, Bobby
This document contains the information required to present a 1-year school course that is the capstone class of a 2-year marketing major and is designed for high school students wishing to develop the skills required for entry into the marketing industry. The document begins with a rationale, brief course description, list of course objectives,…
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Videoconferencing as a Tool for Welfare and Workforce Reform.
ERIC Educational Resources Information Center
Kaplan, April; Van Lare, Barry
2000-01-01
This document explains how agencies serving recipients of Temporary Assistance for Needy Families (TANF) can use videoconferencing as a tool for welfare and work force reform. The document begins with a brief overview of how videoconferencing and other communications technologies can be used in designing and delivering welfare and work force…
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An Analysis of the Commercial Art Occupation.
ERIC Educational Resources Information Center
Mowen, Kenneth A.; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the commercial artist occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Seventeen duties are broken down into a…
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An Analysis of the Machine Trades Occupation.
ERIC Educational Resources Information Center
Hall, Charles W.; Emory, Harold L.
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the machine trades occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Fifteen duties are broken down into a number…
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Iowa School-to-Work Employer Participation Ideas. Developing a Workforce.
ERIC Educational Resources Information Center
Iowa School-to-Work Office, Des Moines.
This document, which is intended for Iowa employers and elementary and secondary educators, outlines 11 activities through which employers can participate in school-to-work (STW) programs in Iowa's elementary and secondary schools. The document begins with a definition of work-based learning and a brief overview of information and other resources…
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An Analysis of the Laboratory Assisting Occupation.
ERIC Educational Resources Information Center
McGee, Patricia; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the laboratory assistant occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Eleven duties are broken down into a…
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[Myths and Realities of Life for Older Americans.
ERIC Educational Resources Information Center
Perspective on Aging, 1975
1975-01-01
The document is comprised of brief excerpts from the Louis Harris and Associates' study for the National Council on the Aging, "The Myth and Reality of Aging in America," the most extensive study ever conducted to determine public attitudes and perceptions of aging in this country, and to document older Americans' views and attitudes…
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An Analysis of the Insurance Sales Occupation.
ERIC Educational Resources Information Center
Moore, Gordon; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the insurance sales occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Eleven duties are broken down into a number…
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An Analysis of the Purchasing Occupation.
ERIC Educational Resources Information Center
Lustic, Gary; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the purchasing occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Fourteen duties are broken down into a number of…
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Neuroscience and Special Education. inForum
ERIC Educational Resources Information Center
Muller, Eve
2011-01-01
The purpose of this document is to provide a brief overview of how links are being developed between the rapidly expanding field of neuroscience and the practice of special education. The first part of the document introduces definitions and terminology, provides an overview of how findings from neuroscience are being applied to the field of…
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Educational Exchanges between the United States and the Soviet Union.
ERIC Educational Resources Information Center
Altenberger, Alicja
1989-01-01
Following a brief introductory discussion concerning organizations, activities, and agreements that promote exchanges between the United States and the Soviet Union, this document provides: (1) an annotated bibliography of 18 ERIC documents and books on cultural, scientific, and educational exchanges between the U.S. and the U.S.S.R.; and (2) a…
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Research on School Television in Japan, 1953-1983.
ERIC Educational Resources Information Center
Akiyama, Takashiro
Published on the occasion of the 30th anniversary of the school television broadcasting industry in Japan, this document reviews and summarizes the results of past research on the Japanese school television system and considers its future direction. After a brief introduction, the document is divided into six sections: (1) a prehistory of school…
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An Analysis of the Lithographic Printing Occupation.
ERIC Educational Resources Information Center
Innis, Gene A.; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the lithographic printing occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Nine duties are broken down into a…
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Portfolio langagier en francais (Language Portfolios in French).
ERIC Educational Resources Information Center
Laplante, Bernard; Christiansen, Helen
2001-01-01
Suggests that first-year college students learning French should create a language portfolio that contains documents that illustrate what they have learned in French, along with a brief statement of what linguistic skill the document demonstrates. The goal of the portfolio is to make students more aware of their own learning, their strengths, and…
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An Analysis of the Information Receptionist Occupation.
ERIC Educational Resources Information Center
Sams, Helen C.; Snyder, Lois M.
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the information receptionist occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Ten duties are broken down into a…
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An Analysis of the Industrial Sales Occupation.
ERIC Educational Resources Information Center
Kitzmiller, Charles C.; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the industrial sales occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Eight duties are broken down into a number…
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Aquaculture Thesaurus: Descriptors Used in the National Aquaculture Information System.
ERIC Educational Resources Information Center
Lanier, James A.; And Others
This document provides a listing of descriptors used in the National Aquaculture Information System (NAIS), a computer information storage and retrieval system on marine, brackish, and freshwater organisms. Included are an explanation of how to use the document, subject index terms, and a brief bibliography of the literature used in developing the…
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EMSE at TREC 2015 Clinical Decision Support Track
2015-11-20
pseudo relevant documents, semantic ressources of UMLS , and a hybrid approach called SMERA that combines LSI and UMLS based approaches. Only three of...approach to query expansion uses ontologies ( UMLS ) and a lo- cal approach based on pseudo relevant feedback documents using LSI. A brief description of...pseudo relevance feedback documents, and a semantic method based on UMLS concepts. The LSI-based method was used only to expand summary terms that can’t
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Dronedarone: current evidence and future questions.
Schafer, Jeremy A; Kjesbo, Nicole K; Gleason, Patrick P
2010-01-01
Atrial fibrillation (AF) is the most common sustained arrhythmia, affecting more than 2.2 million Americans. ACC/AHA/ESC guidelines for the management of patients with AF recommend amiodarone for maintaining sinus rhythm. Dronedarone is a derivative of amiodarone indicated for the treatment of AF. To provide an overview of dronedarone with a focus on the phase III trials and discuss unresolved questions of dronedarone. A literature search was conducted via the PubMed database using the keyword "dronedarone." Search was limited to human trials in english. The FDA website was searched for briefing documents and subcommittee meetings on dronedarone. Clinicaltrials.gov was searched with the keyword dronedarone for upcoming or unpublished clinical trials. Five phase III trials are available for dronedarone: ANDROMEDA, EURIDIS/ADONIS, ATHENA, ERATO, and DIONYSIS. EURIDIS/ADONIS and ATHENA demonstrated a reduction AF recurrence with dronedarone compared to placebo. The ANDROMEDA trial recruited patients with recent hospitalization for heart failure and was terminated due to an excess of deaths in the dronedarone group. The DIONYSIS trial was a comparative effectiveness trial that demonstrated less efficacy for dronedarone but improved tolerability compared to amiodarone. Dronedarone represents an option in the management of AF in select patients. Dronedarone is not appropriate in patients with recently decompensated heart failure or those treated with strong CYP3A4 inhibitors or medications prolonging the QT interval. Dronedarone appears to have improved tolerability at the expense of decreased efficacy when compared to amiodarone. Questions remain on the long-term safety, use in patients with heart failure, retreatment after dronedarone or amiodarone failure, and comparative efficacy with a rate control strategy.
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Natural Channel Design Review Checklist
This document presents a brief description of the checklist items by the following sections: Watershed and Geomorphic Assessment, Preliminary Design, Final Design, and Maintenance and Monitoring Plans.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...
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ERIC Educational Resources Information Center
Campbell, Sarah vL.
This document is intended to create an opportunity for teens and adults to talk together and find ways to make their community a place where young people can grow up successfully. The discussion guide begins with a brief statement of purpose and a brief explanation of study circles and their objectives. The remainder of the guide consists of…
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ERIC Educational Resources Information Center
Hoyer, Kathleen Mulvaney; Sparks, Dinah
2017-01-01
The National Center for Education Statistics (NCES) has published a number of reports documenting the amount of time that students have received instruction in various subjects. Using more recent data and similar measures, this Statistics in Brief builds on prior reports to provide an updated look at time spent on instruction in various subjects.…
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Policy Level Information on Logistics-Oriented Research.
1980-08-01
Logistics Planann and System Long-Range Management Technology Planning Evaluation of Rold Miasion of Support Organizacion Effective Cross-Service Policies...guidelines, solution procedures, etc. The documentation format (technical report, user’s manual , briefing slides, etc.) also falls into this category...CHECK AT LEAST ONE) PhD Dissertation SMaster’s Thesis 7 Memorandum L Briefing Q Technical Report 7 Software Product O Hardware Product Q7 User’s Manual
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-07
..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability...\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...
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An Analysis of the Real Estate Property Managing Occupation.
ERIC Educational Resources Information Center
Bryan, James E.
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the real estate property manager occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Eleven duties are broken down…
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An Analysis of the Payroll Clerking Occupation.
ERIC Educational Resources Information Center
Peal, Sharyn; Rose, Virginia
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the payroll clerk occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Ten duties are broken down into a number of…
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An Analysis of the Auto Body Repair Occupation.
ERIC Educational Resources Information Center
Stranke, Edward J.; Speck, Samuel R.
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the auto body mechanic occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Eleven duties are broken down into a…
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First Steps to Endangered Language Documentation: The Kalasha Language, a Case Study
ERIC Educational Resources Information Center
Mela-Athanasopoulou, Elizabeth
2011-01-01
The present paper based on extensive fieldwork D conducted on Kalasha, an endangered language spoken in the three small valleys in Chitral District of Northwestern Pakistan, exposes a spontaneous dialogue-based elicitation of linguistic material used for the description and documentation of the language. After a brief display of the basic typology…
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An Analysis of the Waste Water Treatment Maintenance Mechanic Occupation.
ERIC Educational Resources Information Center
Clark, Anthony B.; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the waste water treatment mechanics occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Twelve duties are broken…
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An Analysis of the Television and Radio Service Occupation.
ERIC Educational Resources Information Center
Pomeroy, James W.; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the television and radio service occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Eight duties are broken down…
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An Analysis of the Air Conditioning, Refrigerating and Heating Occupation.
ERIC Educational Resources Information Center
Frass, Melvin R.; Krause, Marvin
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the air conditioning, refrigerating, and heating occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Six duties are…
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An Analysis of the Diesel Truck Mechanic Occupation.
ERIC Educational Resources Information Center
Kilo, Joseph L.
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the diesel truck mechanic occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Thirteen duties are broken down into a…
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ERIC Educational Resources Information Center
Harding, Juliana M.; Mann, Roger; Clark, Vicki P.
This document introduces Virginia's Oyster Reef Teaching EXperience (VORTEX), which is an interdisciplinary program focusing on the importance of oyster reef communities in the Chesapeake Bay ecosystem. The VORTEX program uses field and laboratory experience supported by multimedia instruction. This document presents an overview on the biology of…
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Music Accommodation in Secondary Schools. A Design Guide. Building Bulletin 86.
ERIC Educational Resources Information Center
Watson, Lucy; Wadsworth, Alison; Nichols, Helen; Daniels, Richard; Marshall, Christopher; Orlowski, Rafal
This document provides guidance on accommodations in secondary schools, concentrating on the needs of 11- to 16-year-old pupils. The guidance is intended to assist all those who may be involved in the briefing and design process. It discusses the issues that arise when considering both new and existing accommodations. The document covers the range…
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An Analysis of the Dental Assisting Occupation.
ERIC Educational Resources Information Center
Hough, Sharon L.; And Others
The general purpose of the occupational analysis is to provide workable, basic information dealing with the many and varied duties performed in the dental assistant occupation. The document opens with a brief introduction followed by a job description. The bulk of the document is presented in table form. Six duties are broken down into a number of…
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[Methodology for the development of policy brief in public health].
Felt, Emily; Carrasco, José Miguel; Vives-Cases, Carmen
2018-01-10
A policy brief is a document that summarizes research to inform policy. In a brief and succinct way, it defines a policy problem, presents a synthesis of relevant evidence, identifies possible courses of action and makes recommendations or key points. The objective of this note is to describe the methodology used to produce a policy brief for communicating public health research. This note is based on the model presented by Eugene Bardach in addition to the authors' own experiences. We describe six steps: 1) identifying the audience; 2) defining the problem; 3) gathering information and evidence; 4) consideration of policy alternatives; 5) projecting results and designing recommendations; and 6) telling the story. We make a case for the use of policy briefs as a part of an overall communications strategy for research that aims to bring together research teams and stakeholders. Copyright © 2017 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.
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Phosphodiesterase type 5 inhibitor abuse: a critical review.
Lowe, Gregory; Costabile, Raymond
2011-06-01
Abuse of sildenafil has been reported since its introduction in 1999 and commonly documented in combination with illicit drugs among men and women of all ages. Increased risks of sexually transmissible diseases including HIV have been associated with sildenafil use in men who have sex with men. Recognizing the abuse potential of phosphodiesterase type 5 inhibitors (PDE5), we aim to summarize the current knowledge of this abuse. An investigation of EMBASE, PubMed, the Food and Drug Administration (FDA) website, MedWatch, and search engines was performed to evaluate information regarding sildenafil, tadalafil, and vardenafil abuse. The EMBASE search provided 46 articles fitting the search criteria and evaluation led to 21 separate publications with specific information regarding PDE5 abuse. A PubMed search found 10 additional publications. MedWatch reported 44 separate warnings since 2000, most of which reported contamination of herbal products with active drug components. Few reports of abuse were among the 14,818 reports in the FDA AERS for sildenafil. A search for "internet drug store" revealed 6.4 million hits and of 7000 internet pharmacies identified by the Verified Internet Pharmacy Practice Sites Program (VIPPS) only 4% were in proper compliance. The role internet pharmacies play in counterfeit PDE5 or abuse is not well documented; however based on easy access, direct patient marketing, and low advertised cost it is likely this role is underreported. Currently the best recommendation for providers is to recognize the possibility of abuse and to educate patients on risks of this behavior.
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Shetty, Yashashri C; Saiyed, Aafreen A
2015-05-01
The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators, while failure to follow standard operating procedures and maintain documentation was noted as significant in warning letters to IRBs. Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide. 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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2009-10-01
parameters for a large number of species. These authors provide many sample calculations with the JCZS database incorporated in CHEETAH 2.0, including...FORM (highest classification of Title, Abstract, Keywords) DOCUMENT CONTROL DATA (Security classification of title, body of abstract and...CLASSIFICATION OF FORM 13. ABSTRACT (a brief and factual summary of the document. It may also appear elsewhere in the body of the document itself
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1992-10-16
The Spread of Viruses Programs have been developed to attack some of these problems , primarily in the virus arena. Pick up any PC magazine and you...a particular DBMS-specific research area. These documents discuss the research problem , present an overview of relevant research and development ...MITRE has developed to date and a brief discussion those documents currently under development . For each companion document, the problem being
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Review of the role of NICE in promoting the adoption of innovative cardiac technologies.
Groves, Peter H; Pomfrett, Chris; Marlow, Mirella
2018-05-17
The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system. Diagnostic guidance is published for diagnostic technologies if they have the potential to improve health outcomes, but if their introduction may be associated with an increase in overall cost to the NHS. Medtechinnovation briefings provide evidence-based advice to those considering the implementation of new medical devices or diagnostic technologies. This review provides reference to all of the guidance and briefing medical technology documents that NICE has published that are relevant to the heart and circulation and reflect on their diverse recommendations. The interaction of MTEP with other NICE programmes is integral to its effectiveness and the means by which consistency is ensured across the different NICE programmes is described. The importance of the input of clinical experts from the cardiovascular professional community and the engagement by NICE with cardiovascular professional societies is highlighted as being fundamental to ensuring the quality of guidance outputs as well as to promoting their implementation and adoption. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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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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In search of colonial El Niño events and a brief history of meteorology in Ecuador
NASA Astrophysics Data System (ADS)
Terneus, A.; Gioda, A.
2006-02-01
This study shows a brief overview of the development of meteorology in Ecuador from historical documentation of climatic events in the Colonial era through to modern data collection. In the colonial era (16th century-1824), historical documents of rogation ceremonies and municipal proceedings, from the Quito area, provide a rich source of climate information, including El Niño events. Our preliminary findings show that very few of the historically documented catastrophes and other marked environmental events in Quito match known El Niño episodes. Independently, the first meteorological data was collected in Ecuador (beginning with La Condamine in 1738), followed by the earliest attempts to build a national meteorological network in the 1860's, linked closely to President Gabriel García Moreno and the Jesuits. The 1925 El Niño phenomenon was the first important meteorological episode recorded with scientific instrumentation in Ecuador, with newspapers providing complementary archives about the extreme impact of this event.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Schiller, Steven R.; Schwartz, Lisa C.
Demand-side energy efficiency (efficiency) represents a low-cost opportunity to reduce electricity consumption and demand and provide a wide range of non-energy benefits, including avoiding air pollution. Efficiency-related energy and non-energy impacts are determined and documented by implementing evaluation, measurement and verification (EM&V) systems. This technical brief describes efficiency EM&V coordination strategies that Western states can consider taking on together, outlines EM&V-related products that might be appropriate for multistate coordination, and identifies some implications of coordination. Coordinating efficiency EM&V activities can save both time and costs for state agencies and stakeholders engaged in efficiency activities and can be particularly beneficial formore » multiple states served by the same utility. First, the brief summarizes basic information on efficiency, its myriad potential benefits and EM&V for assessing those benefits. Second, the brief introduces the concept of multistate EM&V coordination in the context of assessing such benefits, including achievement of state and federal goals to reduce air pollutants.1 Next, the brief presents three coordination strategy options for efficiency EM&V: information clearinghouse/exchange, EM&V product development, and a regional energy efficiency tracking system platform. The brief then describes five regional EM&V products that could be developed on a multistate basis: EM&V reporting formats, database of consistent deemed electricity savings values, glossary of definitions and concepts, efficiency EM&V methodologies, and EM&V professional standards or accreditation processes. Finally, the brief discusses options for next steps that Western states can take to consider multistate coordination on efficiency EM&V. Appendices provide background information on efficiency and EM&V, as well as definitions and suggested resources on the covered topics. This brief is intended to inform state public utility commissions, boards for public and consumer-owned utilities, state energy offices and air agencies, and other organizations involved in discussions about the use of efficiency EM&V.« less
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The basics of preclinical drug development for neurodegenerative disease indications.
Steinmetz, Karen L; Spack, Edward G
2009-06-12
Preclinical development encompasses the activities that link drug discovery in the laboratory to initiation of human clinical trials. Preclinical studies can be designed to identify a lead candidate from several hits; develop the best procedure for new drug scale-up; select the best formulation; determine the route, frequency, and duration of exposure; and ultimately support the intended clinical trial design. The details of each preclinical development package can vary, but all have some common features. Rodent and nonrodent mammalian models are used to delineate the pharmacokinetic profile and general safety, as well as to identify toxicity patterns. One or more species may be used to determine the drug's mean residence time in the body, which depends on inherent absorption, distribution, metabolism, and excretion properties. For drugs intended to treat Alzheimer's disease or other brain-targeted diseases, the ability of a drug to cross the blood brain barrier may be a key issue. Toxicology and safety studies identify potential target organs for adverse effects and define the Therapeutic Index to set the initial starting doses in clinical trials. Pivotal preclinical safety studies generally require regulatory oversight as defined by US Food and Drug Administration (FDA) Good Laboratory Practices and international guidelines, including the International Conference on Harmonization. Concurrent preclinical development activities include developing the Clinical Plan and preparing the new drug product, including the associated documentation to meet stringent FDA Good Manufacturing Practices regulatory guidelines. A wide range of commercial and government contract options are available for investigators seeking to advance their candidate(s). Government programs such as the Small Business Innovative Research and Small Business Technology Transfer grants and the National Institutes of Health Rapid Access to Interventional Development Pilot Program provide funding and services to assist applicants in preparing the preclinical programs and documentation for their drugs. Increasingly, private foundations are also funding preclinical work. Close interaction with the FDA, including a meeting to prepare for submission of an Investigational New Drug application, is critical to ensure that the preclinical development package properly supports the planned phase I clinical trial.
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The basics of preclinical drug development for neurodegenerative disease indications
Steinmetz, Karen L; Spack, Edward G
2009-01-01
Preclinical development encompasses the activities that link drug discovery in the laboratory to initiation of human clinical trials. Preclinical studies can be designed to identify a lead candidate from several hits; develop the best procedure for new drug scale-up; select the best formulation; determine the route, frequency, and duration of exposure; and ultimately support the intended clinical trial design. The details of each preclinical development package can vary, but all have some common features. Rodent and nonrodent mammalian models are used to delineate the pharmacokinetic profile and general safety, as well as to identify toxicity patterns. One or more species may be used to determine the drug's mean residence time in the body, which depends on inherent absorption, distribution, metabolism, and excretion properties. For drugs intended to treat Alzheimer's disease or other brain-targeted diseases, the ability of a drug to cross the blood brain barrier may be a key issue. Toxicology and safety studies identify potential target organs for adverse effects and define the Therapeutic Index to set the initial starting doses in clinical trials. Pivotal preclinical safety studies generally require regulatory oversight as defined by US Food and Drug Administration (FDA) Good Laboratory Practices and international guidelines, including the International Conference on Harmonisation. Concurrent preclinical development activities include developing the Clinical Plan and preparing the new drug product, including the associated documentation to meet stringent FDA Good Manufacturing Practices regulatory guidelines. A wide range of commercial and government contract options are available for investigators seeking to advance their candidate(s). Government programs such as the Small Business Innovative Research and Small Business Technology Transfer grants and the National Institutes of Health Rapid Access to Interventional Development Pilot Program provide funding and services to assist applicants in preparing the preclinical programs and documentation for their drugs. Increasingly, private foundations are also funding preclinical work. Close interaction with the FDA, including a meeting to prepare for submission of an Investigational New Drug application, is critical to ensure that the preclinical development package properly supports the planned phase I clinical trial. PMID:19534731
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Goldberg, Roger A; Flynn, Harry W; Miller, Darlene; Gonzalez, Serafin; Isom, Ryan F
2013-07-01
To report the 1-year clinical outcomes of an outbreak of Streptococcus endophthalmitis after intravitreal injection of bevacizumab, including visual acuity outcomes, microbiological testing, and compound pharmacy investigations by the Food and Drug Administration (FDA). Retrospective consecutive case series. Twelve eyes of 12 patients who developed endophthalmitis after receiving intravitreal bevacizumab prepared by a single compounding pharmacy. Medical records of patients were reviewed; phenotypic and DNA analyses were performed on microbes cultured from patients and from unused syringes. An inspection report by the FDA based on site visits to the pharmacy that prepared the bevacizumab syringes was summarized. Visual acuity, interventions received, time to intervention, microbiological consistency, and FDA inspection findings. Between July 5 and 8, 2011, 12 patients developed endophthalmitis after intravitreal bevacizumab from syringes prepared by a single compounding pharmacy. All patients received initial vitreous tap and injection, and 8 patients (67%) subsequently underwent pars plana vitrectomy (PPV). After 12 months follow-up, outcomes have been poor. Seven patients (58%) required evisceration or enucleation, and only 1 patient regained pre-injection visual acuity. Molecular testing using real-time polymerase chain reaction, partial sequencing of the groEL gene, and multilocus sequencing of 7 housekeeping genes confirmed the presence of a common strain of Streptococcus mitis/oralis in vitreous specimens and 7 unused syringes prepared by the compounding pharmacy at the same time. An FDA investigation of the compounding pharmacy noted deviations from standard sterile technique, inconsistent documentation, and inadequate testing of equipment required for safe preparation of medications. In this outbreak of endophthalmitis, outcomes have been generally poor, and PPV did not improve visual results at 1-year follow-up. Molecular testing confirmed a common strain of S. mitis/oralis. Contamination seems to have occurred at the compounding pharmacy, where numerous problems in sterile technique were noted by public health investigators. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Goldberg, Roger A.; Flynn, Harry W.; Miller, Darlene; Gonzalez, Serafin; Isom, Ryan F.
2013-01-01
Purpose To report the one-year clinical outcomes of an outbreak of Streptococcus endophthalmitis after intravitreal injection of bevacizumab, including visual acuity outcomes, microbiological testing and compound pharmacy investigations by the Food and Drug Administration (FDA). Design Retrospective consecutive case series. Participants 12 eyes of 12 patients who developed endophthalmitis after receiving intravitreal bevacizumab prepared by a single compounding pharmacy. Methods Medical records of patients were reviewed; phenotypic and DNA analyses were performed on microbes cultured from patients and from unused syringes. An inspection report by the FDA based on site-visits to the pharmacy that prepared the bevacizumab syringes was summarized. Main Outcome Measures Visual acuity, interventions received, time-to-intervention; microbiological consistency; FDA inspection findings. Results Between July 5 and July 8, 2011, 12 patients developed endophthalmitis after intravitreal bevacizumab from syringes prepared by a single compounding pharmacy. All patients received initial vitreous tap and injection, and eight (67%) subsequently underwent pars plana vitrectomy (PPV). After twelve months follow-up, outcomes have been poor: 7 patients (58%) required evisceration or enucleation, and only one patient regained pre-injection visual acuity. Molecular testing using real time polymerase chain reaction, partial sequencing of the groEL gene, and multilocus sequencing of 7 housekeeping genes confirmed the presence of a common strain of Streptococcus mitis/oralis in vitreous specimens and seven unused syringes prepared by the compounding pharmacy at the same time. An FDA investigation of the compounding pharmacy noted deviations from standard sterile technique, inconsistent documentation, and inadequate testing of equipment required for safe preparation of medications. Conclusions In this outbreak of endophthalmitis, outcomes have been generally poor and PPV did not improve visual results at one year follow-up. Molecular testing confirmed a common strain of Streptococcus mitis/oralis. Contamination appears to have occurred at the compounding pharmacy, where numerous problems in sterile technique were noted by public health investigators. PMID:23453511
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Macaulay, Richard; Siddiqui, Mohammad Kashif; Stoddart, Samuel
2015-05-01
Oncology drugs lacking supportive phase III trial data have achieved Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory approval and even European reimbursement approval where no therapeutic alternative exists and early-stage data indicate dramatic clinical benefits. This research aimed to compare under what circumstances oncologics can obtain both regulatory and reimbursement approval in Australia on this basis. Therapeutic Goods Administration (TGA) Australian Public Assessment Reports, EMA, FDA, and Pharmaceutical Benefits Advisory Committee (PBAC) Public Summary Documents were extracted for any oncologic indication appraised in Australia on a pivotal trial package lacking phase III data, excluding pediatric indications and new formulations. Australian Public Assessment Reports were available for six TGA-appraised oncologics across seven indications on such a data package: five of seven approved, one of seven restricted, and one of seven rejected. The EMA and the FDA issued recommendations on these indications an average of 1 and 2 years earlier, respectively. The PBAC appraised six oncologics across 10 indications on such a data package, with four (nilotinib, dasatinib, imatinib, and brentuximab vedotin) approved and two rejected (cetuximab and bevacizumab). Seven of the eight approved indications required multiple submissions, with inadequate clinical data frequently cited as key. Six of the eight PBAC-approved indications included economic modeling on a cost-benefit approach. The TGA will approve oncologics that offer potentially substantial clinical benefits on the basis of an indirect comparison of single-arm trials but at a delay versus the EMA and the FDA. The PBAC reimbursement approval also requires more rigorous supportive clinical data and acceptable cost-effectiveness as demonstrated on a cost-benefit or cost-quality-adjusted life-year metric. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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ERIC Educational Resources Information Center
Dembo, Richard; Briones-Robinson, Rhissa; Barrett, Kimberly; Winters, Ken C.; Schmeidler, James; Ungaro, Rocio Aracelis; Karas, Lora; Belenko, Steven; Gulledge, Laura
2013-01-01
The relationship between substance use, mental health disorders, and delinquency among youth is well documented. What has received far less attention from researchers is the relationship between these issues among truant youth, in spite of studies that document truants are a population at risk for negative outcomes. This study bridges this gap by…
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
This document consists of a list of projects supporting work on oil recovery programs. A publications list and index of companies and institutions is provided. The remaining portion of the document provides brief descriptions on projects in chemical flooding, gas displacement, thermal recovery, geoscience, resource assessment, and reservoir class field demonstrations.
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ERIC Educational Resources Information Center
Keenan, Terrance
This document describes the contents of the Alexander N. Charters Library of Resources for Educators of Adults at Syracuse University Library. The document begins with a brief history of the development of the library's collections, which occupy 900 feet of shelf space and contain more than 50 groups of personal papers and records of organizations…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-18
.... A request for such a waiver has been received by MARAD. The vessel, and a brief description of the... 10 a.m. and 5 p.m., E.T., Monday through Friday, except federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at http...
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Writing Clinic for Business and Technical Writers.
ERIC Educational Resources Information Center
Mercer County Community Coll., Trenton, NJ.
This document offers brief lesson plans for four courses: (1) an 8-hour refresher course for employees who write memos, short reports, and letters; (2) an 8-hour refresher course on creating a short document; (3) a 16-hour course on technical manual writing; and (4) an 8-hour course on technical manual writing. The courses were part of a workplace…
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Astronomical catalog desk reference, 1994 edition
NASA Technical Reports Server (NTRS)
1994-01-01
The Astronomical Catalog Desk Reference is designed to aid astronomers in locating machine readable catalogs in the Astronomical Data Center (ADC) archives. The key reference components of this document are as follows: A listing of shortened titles for all catalogs available from the ADC (includes the name of the lead author and year of publication), brief descriptions of over 300 astronomical catalogs, an index of ADC catalog numbers by subject keyword, and an index of ADC catalog numbers by author. The heart of this document is the set of brief descriptions generated by the ADC staff. The 1994 edition of the Astronomical Catalog Desk Reference contains descriptions for over one third of the catalogs in the ADC archives. Readers are encouraged to refer to this section for concise summaries of those catalogs and their contents.
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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... and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical ... æ¥æ¬èª | ÙØ§Ø±Ø³Û | English FDA Accessibility Careers FDA Basics FOIA No FEAR Act ...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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78 FR 18233 - Medical Devices; Technical Amendment
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
... the right column: Section Remove Add 814.20 http://www.fda.gov/ http://www.fda.gov/ cdrh/devadvice.../ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/ AboutFDA/ dispute.html. CentersOffices/ OfficeofMedicalPr oductsandTobacco/ CDRH/ CDRHOmbudsman/ default.htm. 822.15...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Shleien, B.; Schmidt, G.D.; Chiacchierini, R.P.
This report provides background material for the development of FDA's Protective Action Recommendations: Accidental Radioactive Contamination of Food and Animal Feeds. The rationale, dosimetric and agricultural transport models for the Protective Action Guides are presented, along with information on dietary intake. In addition, the document contains a discussion of field methods of analysis of radionuclides deposited on the ground or contained in milk and herbage. Various protective actions are described and evaluated, and a cost-effectiveness analysis for the recommendations performed.
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Bailey, Timothy S; Grunberger, George; Bode, Bruce W; Handelsman, Yehuda; Hirsch, Irl B; Jovanovič, Lois; Roberts, Victor Lawrence; Rodbard, David; Tamborlane, William V; Walsh, John
2016-02-01
This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.
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2012-12-01
requirements as part of an overall medical support concept In this document several potential CONOPS proposals are added as food for thought (see Chapter 4...safe flight minimums for manned flight; • En route or terminal environment (landing zone) is contaminated by an industrial spill or by a CBRN event...Further, the U.S. Food and Drug Administration (FDA) and other national/international medical regulatory authorities have requirements for portable
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Wertz, Marcia S.; Kyriss, Thomas; Paranjape, Suman; Glantz, Stanton A.
2011-01-01
Background In 2009, the promulgation of US Food and Drug Administration (FDA) tobacco regulation focused attention on cigarette flavor additives. The tobacco industry had prepared for this eventuality by initiating a research program focusing on additive toxicity. The objective of this study was to analyze Philip Morris' Project MIX as a case study of tobacco industry scientific research being positioned strategically to prevent anticipated tobacco control regulations. Methods and Findings We analyzed previously secret tobacco industry documents to identify internal strategies for research on cigarette additives and reanalyzed tobacco industry peer-reviewed published results of this research. We focused on the key group of studies conducted by Phillip Morris in a coordinated effort known as “Project MIX.” Documents showed that Project MIX subsumed the study of various combinations of 333 cigarette additives. In addition to multiple internal reports, this work also led to four peer-reviewed publications (published in 2001). These papers concluded that there was no evidence of substantial toxicity attributable to the cigarette additives studied. Internal documents revealed post hoc changes in analytical protocols after initial statistical findings indicated an additive-associated increase in cigarette toxicity as well as increased total particulate matter (TPM) concentrations in additive-modified cigarette smoke. By expressing the data adjusted by TPM concentration, the published papers obscured this underlying toxicity and particulate increase. The animal toxicology results were based on a small number of rats in each experiment, raising the possibility that the failure to detect statistically significant changes in the end points was due to underpowering the experiments rather than lack of a real effect. Conclusion The case study of Project MIX shows tobacco industry scientific research on the use of cigarette additives cannot be taken at face value. The results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes, including the level of TPM. In particular, regulatory authorities, including the FDA and similar agencies elsewhere, could use the Project MIX data to eliminate the use of these 333 additives (including menthol) from cigarettes. Please see later in the article for the Editors' Summary PMID:22205885
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21 CFR 1.280 - How must you submit prior notice?
Code of Federal Regulations, 2010 CFR
2010-04-01
... to FDA. You must submit all prior notice information in the English language, except that an... Commercial System (ABI/ACS); or (2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through the FDA Prior Notice System Interface (FDA PNSI) for articles of food imported or offered for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-31
... Safety Testing of Sunlamp Products'' Form FDA 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' Form FDA 3633''General Variance Request'' Form FDA 3634 ``Television Products Annual Report'' Form FDA 3635 ``Laser Light Show Notification'' Form FDA 3636 ``Guide for Preparing...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-12
... Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products'' FDA Form 3637...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-13
... of Sunlamps and Sunlamp Products'' FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2012 CFR
2012-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2013 CFR
2013-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2010 CFR
2010-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2011 CFR
2011-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2014 CFR
2014-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...
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21 CFR 830.100 - FDA accreditation of an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... issuing agency. (b) Accreditation criteria. FDA may accredit an organization as an issuing agency, if the...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
This volume and its appendixes supplement the Advisory Committee`s final report by reporting how we went about looking for information concerning human radiation experiments and intentional releases, a description of what we found and where we found it, and a finding aid for the information that we collected. This volume begins with an overview of federal records, including general descriptions of the types of records that have been useful and how the federal government handles these records. This is followed by an agency-by-agency account of the discovery process and descriptions of the records reviewed, together with instructions on how tomore » obtain further information from those agencies. There is also a description of other sources of information that have been important, including institutional records, print resources, and nonprint media and interviews. The third part contains brief accounts of ACHRE`s two major contemporary survey projects (these are described in greater detail in the final report and another supplemental volume) and other research activities. The final section describes how the ACHRE information-nation collections were managed and the records that ACHRE created in the course of its work; this constitutes a general finding aid for the materials deposited with the National Archives. The appendices provide brief references to federal records reviewed, descriptions of the accessions that comprise the ACHRE Research Document Collection, and descriptions of the documents selected for individual treatment. Also included are an account of the documentation available for ACHRE meetings, brief abstracts of the almost 4,000 experiments individually described by ACHRE staff, a full bibliography of secondary sources used, and other information.« less
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... on the relevance score as determined by the search engine. Generally, the first document in the first results ... Spanish . snippet Brief result summary generated by the search engine that provides a preview of the relevant content ...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...