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Sample records for administration fda announced

  1. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  2. FDA reform floated in DC. Food and Drug Administration.

    PubMed

    Hodel, D

    1995-06-01

    Legislative proposals to reform the mandate of the Food and Drug Administration (FDA) are underway in Washington. An ad hoc coalition has been formed by many leading AIDS groups to participate in the debate. The group is drafting principles for evaluating FDA reform proposals from the standpoint of people with life-threatening disease. Items under discussion for the reform include shifting more efficacy studies to a post-marketing setting. This would enable drugs to reach the market much faster; however, the risks are greater because more people will be taking the drugs with less data about hazards. Another measure would utilize local Institutional Review Boards (IRBs) to review proposals for the early human testing (phase I clinical trials) on drugs. In addition, a measure was proposed that would privatize certain drug safety reviews, by relegating them to independent testing or accrediting institutions. Another measure would permit the promotion of FDA-approved drugs for off-label uses. A measure to impose statutory time limits on FDA review is also under discussion. Finally, the possible removal of export barriers for non-FDA-approved drugs is under review.

  3. FDA seeks temporary blood donor changes. Food and Drug Administration.

    PubMed

    1997-02-01

    The Food and Drug Administration (FDA) has requested that blood collection agencies exclude donors at risk of Group O HIV, following two cases identified in 1996. Group O is very rare in the United States. Blood donors would be excluded if they were born or lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger or Nigeria since 1977, or had sexual conduct with anyone traveling to those areas. The number of excluded donors would be minute.

  4. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  5. FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

    PubMed

    James, J S

    1998-03-01

    The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

  6. Reform at FDA: faster access to promising drugs? Food and Drug Administration.

    PubMed

    Baker, R

    1995-06-01

    The Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs, vaccines, and medical devices are safe and effective, is under hot debate by Congress, the Clinton administration, and the AIDS community. The Clinton/Gore proposal favors excluding drug and biologic manufacturers from requirements for more environmental assessments and only indirectly addresses drug development. Oregon Democratic Congressman Ron Wyden introduced an FDA reform bill which calls for the FDA to use expert panels, independent testing organizations, and institutional review boards (IRB) to help speed new drugs and devices through the approval process. The bill calls for the use of the IRB for the approval (or denial) of applications for Phase I review of new drugs. Not surprisingly, the AIDS community has differing views on the reform at the FDA. The Treatment Action Group (TAG), whose members hold key positions in well-known AIDS groups, supports the status quo at FDA and is lobbying AIDS organizations across the country to sign on to its FDA Reform Principles. Other AIDS treatment activists, such as members of ACT UP, favor local IRB jurisdiction over Phase I research.

  7. NCL Partnerships - U.S. Food and Drug Administration (FDA)- Nanotechnology Characterization Laboratory

    Cancer.gov

    The activities within the NCL represent a formal scientific interaction of three Federal agencies: National Cancer Institute and U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services, and National Institute of Standards and Technology (NIST) of the Department of Commerce.

  8. 78 FR 46347 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Environmental Impact Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that...

  9. 77 FR 37413 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

    ... Coronary Heart Disease Health Claim AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Record... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement...

  10. 75 FR 80823 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement...

  11. The debate on FDA reform: a view from the U.S. Senate. Food and Drug Administration.

    PubMed

    Baker, R

    1995-09-01

    The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs.

  12. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  13. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health

    SciTech Connect

    Not Available

    1983-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section VI provides those chapters of the Compliance Program Guidance Manual which pertain to the area of radiological health. Some of the areas of coverage include laser standards; compliance testing of x-ray equipment, ultrasonic therapy devices, mercury vapor lamps, television receivers, and microwave ovens; radiation policy; and imported electronic products.

  14. Clinton Administration announces FY 2001 budget request

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    Blessed with a strong US. economy the Clinton Administration on February 7 released a fiscal year 2001 federal budget request totaling a whopping $1,835 billion. Most of the funding request is slated for big ticket items including Social Security defense spending, Medicaid, Medicare, and paying down the federal debt. However, within the 19% of the budget that funds non-defense discretionary programs,science agencies receive fairly healthy increases.The National Science Foundation (NSF) budget request would increase NSF funding by 17.3% $675 million and bring the total budget request to $4.6 billion. This includes significant increases for several initiatives: biocomplexity in the environment, information technology research, nanoscale science and engineering, and 21st century workforce. Among the major Earth science projects are launching the Earthscope initiative which includes the US Array and San Andreas Fault Observatory at Depth (SAFOD) and the National Ecological Observatory Network (NEON).

  15. Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

    PubMed

    Pelletier, David L

    2005-05-01

    The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

  16. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal... Marine Environmental Science Consortium-Dauphin Island Sea Lab (DISL) will greatly contribute to FDA's... Objectives FDA Gulf Coast Seafood Laboratory (GCSL) and the Marine Environmental Science Consortium of...

  17. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  18. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  19. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  20. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  1. 78 FR 48689 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  2. 76 FR 71576 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  3. FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Basic section. (FY-89)

    SciTech Connect

    Not Available

    1989-01-01

    The Food and Drug Administration (FDA) Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to the Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  4. FDA (Food and Drug Administration) compliance program guidance manual (FY 87). Section 4. Medical and radiological devices

    SciTech Connect

    Not Available

    1987-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  5. FDA (Food and Drug Administration) Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Irregular report

    SciTech Connect

    Not Available

    1989-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  6. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    SciTech Connect

    Not Available

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  7. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 85). Section 4. Medical and radiological devices

    SciTech Connect

    Not Available

    1985-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  8. 78 FR 76840 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Unique Device Identification System'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  9. 76 FR 72710 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... Office of Management and Budget Approval; Adverse Experience Reporting for Licensed Biological Products... Drug Administration (FDA) is announcing that a collection of information entitled ``Adverse Experience..., the Agency submitted a proposed collection of information entitled ``Adverse Experience Reporting...

  10. Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

    PubMed Central

    Chahal, Harinder S; Sigelman, Daniel W; Stacy, Sylvie; Sclar, Joshua; Ddamulira, Barbara

    2015-01-01

    Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors Design Cross sectional study. Data sources All applications for which FDA’s Center for Drug Evaluation and Research initially issued complete response letters (n=61) from 11 August 2008 to 27 June 2013. Complete response letters and press releases were divided into discrete statements related to seven domains and 64 subdomains and assessed to determine whether they matched. Results 48% (29) of complete response letters cited deficiencies in both the safety and efficacy domains, and only 13% cited neither safety nor efficacy deficiencies. No press release was issued for 18% (11) of complete response letters, and 21% (13) of press releases did not match any statements from the letters. Press release statements matched 93 of the 687 statements (14%), including 16% (30/191) of efficacy and 15% (22/150) of safety statements. Of 32 complete response letters that called for a new clinical trial for safety or efficacy, 59% (19) had matching press release statements. Seven complete response letters reported higher mortality rates in treated participants; only one associated press release mentioned this fact. Conclusions FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters. PMID:26063327

  11. 78 FR 44574 - Third Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Third Annual Food and Drug Administration Health.... The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  12. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Health Professional... Food and Drug Administration (FDA) is announcing a conference for representatives of...

  13. Fabrication of 50-mg /sup 252/Cf neutron sources for the FDA (Food and Drug Administration) activation analysis facility

    SciTech Connect

    Bigelow, J.E.; Cagle, E.B.; Knauer, J.B.

    1987-01-01

    The Transuranium Processing Plant (TPP) at ORNL has been requested by the Food and Drug Administration (FDA) to furnish 200 mg of /sup 252/Cf for use in their new activation analysis facility. This paper discusses the procedure to be employed in fabricating the californium into four neutron sources, each containing a nominal 50-mg of /sup 252/Cf. The ORNL Model LSD (Large, Stainless steel, Doubly encapsulated) neutron source consists of a 6.33-mm-diam aluminum pellet doubly encapsulated in Type 304L stainless steel. The pellet is comprised of an aluminum tube holding Cf/sub 2/O/sub 2/SO/sub 4/ microspheres confined by pressed aluminum powder. The microspheres are prepared in a separate vessel and then transferred into the specially designed aluminum tube prior to pressing.

  14. 77 FR 31026 - Requirements for Importing Food and Drug Administration Regulated Products Into the United States

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... to be discussed are FDA regulations with respect to importing pharmaceutical products, medical... meeting. SUMMARY: The Food and Drug Administration (FDA) is announcing the following meeting..., Chicago, IL 60661; 312-596-4217; email: lisa.misevicz@fda.hhs.gov . Registration: Send...

  15. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced...

  16. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Healthcare Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA...

  17. The Communication of Opportunities and Barriers to Prospective Applicants: An Analysis of Interscholastic Athletic Administrative Job Announcements

    ERIC Educational Resources Information Center

    Miller, John J.; Whisenant, Warren A.; Pedersen, Paul M.

    2007-01-01

    Job announcements often work to either encourage or discourage prospective applicants. The purpose of this investigation was to determine if gender bias existed within the job announcements for interscholastic athletic administrators. The study's results revealed that over a two-year period there were 301 advertisements for positions in the state…

  18. 76 FR 14405 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... Federal Register of July 9, 2010 (75 FR 39541), the Agency announced that the proposed information... Office of Management and Budget Approval; Focus Groups About Drug Products, as Used by the Food and Drug... Administration (FDA) is announcing that a collection of information entitled ``Focus Groups About Drug...

  19. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Pediatric Medical Devices... Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device...

  20. 75 FR 82406 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,...

  1. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

    PubMed Central

    2013-01-01

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  2. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

    PubMed

    Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane

    2013-03-11

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  3. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health. Updates. Irregular repts

    SciTech Connect

    Not Available

    1984-01-01

    The standing order allows one to obtain updates to Section VI of the Compliance Program Guidance Manual which provides plans and instructions to Field operatons which are surveillance and/or compliance oriented and provide needed direction from Headquarters Offices and Bureaus in accomplishing FDA's regulatory obligations for those products monitored for radiation. This section also includes the concept to the Manual and miscellaneous material relating to compliance functions.

  4. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

    The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…

  5. 77 FR 45621 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... ``Reclassification Petitions for Medical Devices'' to OMB for review ] and clearance under 44 U.S.C. 3507. An Agency... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  6. 77 FR 47397 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-08

    ... Office of Management and Budget Approval; MedWatch: The Food and Drug Administration Medical Products... Administration (FDA) is announcing that a collection of information entitled ``MedWatch: The Food and Drug... submitted a proposed collection of information entitled ``MedWatch: The Food and Drug Administration...

  7. 76 FR 32215 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... Small Chains Under Section 4205 of the Patient Protection and Affordable Care Act of 2010 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement...

  8. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop entitled ``FDA Clinical Trial Requirements, Regulations, Compliance, and Good... representatives. The program will focus on the relationships among the FDA and clinical trial staff,...

  9. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the... FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual...

  10. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... Outsourcing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY..., is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference... challenges associated with pharmaceutical outsourcing relationships and supply chain control, as well...

  11. 77 FR 41416 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... Outsourcing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY..., is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference... experts. This conference drives collaboration on the topic of global outsourcing compliance by...

  12. 76 FR 56770 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

    ... Outsourcing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY..., is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference... industry experts. This conference drives collaboration on the topic of global outsourcing compliance...

  13. FDA (Food and Drug Administration) compliance program guidance manual and updates (FY 86). Section 4. Medical and radiological devices. Irregular report

    SciTech Connect

    Not Available

    1986-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  14. 76 FR 67192 - Administration on Children, Youth and Families Announces the Award of a Single-Source Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... HUMAN SERVICES Administration for Children and Families Administration on Children, Youth and Families Announces the Award of a Single-Source Program Expansion Supplement Grant to the National Runaway... the Award of a Single-Source Program Expansion Supplement grant to the National Runaway...

  15. 76 FR 22905 - Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ..., 2010 (75 FR 13225) (21 CFR part 1140). The Tobacco Control Act also authorizes FDA to impose a no... Register of August 31, 2010 (75 FR 53316), FDA announced the availability of the draft guidance of the same... HUMAN SERVICES Food and Drug Administration Guidance for Food and Drug Administration Staff and...

  16. 76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ...'' that appeared in the Federal Register of August 1, 2011 (76 FR 45818). In that document, FDA announced.... Background In the Federal Register of August 1, 2011 (76 FR 45818), FDA published a notice with a 78-day... HUMAN SERVICES Food and Drug Administration Burden of Food and Drug Administration Food...

  17. Internet Database Review: The FDA BBS.

    ERIC Educational Resources Information Center

    Tomaiuolo, Nicholas G.

    1993-01-01

    Describes the electronic bulletin board system (BBS) of the Food and Drug Administration (FDA) that is accessible through the Internet. Highlights include how to gain access; the menu-driven software; other electronic sources of FDA information; and adding value. Examples of the FDA BBS menu and the help screen are included. (LRW)

  18. 75 FR 72827 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adoption of Food and Drug Administration Food Code by Local... of FDA Food Code by Local, State and Tribal Governments'' has been approved by the Office...

  19. 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

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart...

  20. 78 FR 20666 - Food and Drug Administration/National Institutes of Health/National Science Foundation Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    .../ National Science Foundation Public Workshop on Computer Methods for Medical Devices AGENCY: Food and Drug... Administration (FDA) is announcing its fifth public workshop on Computer Methods for Medical Devices entitled ``FDA/ NIH/NSF Workshop on Computer Models and Validation for Medical Devices.'' The purpose of...

  1. Radiological health; evaluation of radiation exposure in diagnostic radiology examinations; availability of draft recommendations--FDA. Notice.

    PubMed

    1983-07-29

    The Food and Drug Administration (FDA) announces the availability for public review and comment of draft recommendations on evaluation of radiation exposure in diagnostic radiology examinations, prepared by FDA's National Center for Devices and Radiological Health (NCDRH). In addition to the draft recommendations, FDA is making available background information, rationale, and NCDRH's response to comments that were received on a notice of inquiry regarding the need for and content of such recommendations. FDA is also encouraging private groups and individuals to join in the research efforts needed to develop further technique/exposure guidance and suggests a number of principles to be followed in these efforts so all interested parties may achieve consistent and useful results. Final recommendations, when developed, will be published as a technical report in NCDRH's radiation recommendation series. PMID:10261489

  2. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ... HUMAN SERVICES Food and Drug Administration Second Annual Food and Drug Administration Health.... The Food and Drug Administration (FDA) is announcing a conference for representatives of health.... Contact Person: Janelle Derbis, Office of Special Health Issues, Food and Drug Administration, 10903...

  3. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance...

  4. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration... Supplemental Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice of intent. SUMMARY: The Food and Drug Administration (FDA) is announcing a program expansion of its Conference...

  5. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration..., Including Certain First in Human Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  6. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration Advisory... Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and... that a meeting of the Science Board to the Food and Drug Administration would be held on February...

  7. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a...

  8. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... HUMAN SERVICES Food and Drug Administration Guidances for Industry and Food and Drug Administration... Approval and Premarket Notification (510(k)) Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  9. 78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug... Administration (FDA) is announcing the establishment of a public docket for comments pertaining to...

  10. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  11. Medical devices; medical device distributor reporting; opportunity for comments--FDA. Final rule; opportunity for comments.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing an opportunity for public comments on the final rule on medical device distributor reporting, which is published elsewhere in this issue of the Federal Register. The medical device distributor reporting tentative final rule became final on May 28, 1992, by operation of the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments). Although not required to do so, FDA realizes that there may be issues not previously considered, such as technical issues on specific provisions, and therefore is providing this additional time for comment. If changes are warranted by comments, FDA will make further changes in the rules.

  12. 78 FR 76841 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  13. 77 FR 42502 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... Office of Management and Budget Approval; Survey of ``Health Care Providers' Responses to Medical Device... Administration (FDA) is announcing that a collection of information entitled Survey of ``Health Care Providers... submitted a proposed collection of information entitled Survey of ``Health Care Providers' Responses...

  14. 78 FR 26783 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... Office of Management and Budget Approval; Public Health Service Guideline on Infectious Disease Issues on... Administration (FDA) is announcing that a collection of information entitled ``Public Health Service Guideline on... Agency submitted a proposed collection of information entitled ``Public Health Service Guideline...

  15. 76 FR 13623 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    .... FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 2010 (75 FR 81616), the Agency announced...

  16. 75 FR 70679 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-18

    ... FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of March 3, 2010 (75 FR 9605), the agency announced that...

  17. 76 FR 66072 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... Office of Management and Budget Approval; Channels of Trade Policy for Commodities With Residues of... Administration (FDA) is announcing that a collection of information entitled ``Channels of Trade Policy for... collection of information entitled ``Channels of Trade Policy for Commodities With Residues of...

  18. The U.S. Food and Drug Administration's Evaluation of the Safety of Animal Clones: A Failure to Recognize the Normativity of Risk Assessment Projects

    ERIC Educational Resources Information Center

    Meghani, Zahra; de Melo-Martin, Inmaculada

    2009-01-01

    The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to…

  19. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  20. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  1. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  2. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  3. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  4. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing...

  5. Access to F.D.A. Information.

    ERIC Educational Resources Information Center

    Sinovic, Dianna

    Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

  6. FDA review panel gives thumbs up to Norplant.

    PubMed

    1989-05-01

    On April 27, the Fertility and Maternal Health Drugs Advisory Committee of the US Food and Drug Administration (FDA) unanimously recommended that Norplant, a long-acting contraceptive implant, be given final FDA approval for marketing in the US. This comes after almost 20 years of research conducted around the world. It was also announced that Wyeth-Ayerst would be manufacturing Norplant for distribution in the US as well as marketing it in countries overseas. FDA officials expect final approval of Norplant, along with its labeling, to be completed within the next several weeks. Norplant will be introduced to the US market, however, only after a full-scale training program has been instituted to ensure enough well-trained providers for both insertion and removal. Wyeth company representatives plan to immediately begin working with experts at the Population Council, and they expect Norplant to be ready for marketing within a year. The final cost of the new method remains in question and detailed post-marketing surveillance studies need to be ready for implementation.

  7. Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010.

    PubMed

    Mallick, Tarun K; Mosquera, Alexis; Zinderman, Craig E; St Martin, Laura; Wise, Robert P

    2012-06-01

    Processors distributed about 1.5 million human tissue allografts in the U.S. in 2007. The potential for transmitting infections through allografts concerns clinicians and patients. In 2005, FDA implemented Current Good Tissue Practice (CGTP) rules requiring tissue establishments to report to FDA certain serious infections after allograft transplantations. We describe infection reports following tissue transplants received by FDA from 2005 through June, 2010, and compare reporting before and after implementation of CGTP rules. We identified reports received by FDA from January 2001 through June, 2010, for infections in human tissue recipients, examining the reports by tissue type, organism, time to onset, severity, and reporter characteristics. Among 562 reports, 83 (20.8/year) were received from 2001-2004, before the CGTP rules, 43 in the 2005 transition year, and 436 (96.9/year) from 2006 through June, 2010, after the rules. Tissue processors accounted for 84.2% of reports submitted after the rules, compared to 26.5% previously. Bacterial infections were the most commonly reported organisms before (64.6%) and after (62.2%) the new rules. Afterward, 2.5% (11) of reports described deaths, and 33.7% (147) involved hospitalizations. Before the rules, 13% (11) described deaths, and another 72% involved hospitalizations. Reports received by the FDA quadrupled since 2005, suggesting that CGTP regulations have contributed to increased reporting and improved tissue safety surveillance. However, these data do not confirm that the reported infections were caused by suspect tissues; most reports may represent routine post-surgical infections not actually due to allografts.

  8. FDA's perspectives on cardiovascular devices.

    PubMed

    Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

    2009-06-01

    The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

  9. 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 Section 314.102 Food 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 FDA Action on Applications and Abbreviated Applications §...

  10. Current FDA directives for promoting public health

    SciTech Connect

    Hayes, A.H. Jr.

    1982-03-01

    The current directions of the FDA are outlined. The underlying philosophy of the FDA under the Reagan Administration is that both the private sector and the government must address the responsibilities to which they are best suited for the health-care system to work more efficiently. To facilitate this, FDA is conducting comprehensive reviews of FDA regulations and the drug-evaluation process. There are many dimensions to promoting public health, and the FDA alone cannot assure an adequate supply of safe and effective drugs. Innovative science and technology are needed to develop new drugs, followed by maximum potentiation (maximum good and least harm) after FDA approval. Hospital pharmacists have a role in maximizing the potential benefits of drugs through pharmacy and therapeutics committees. The current status of the pilot program for patient package inserts is described. The response at a recent hearing on the program indicates that the responsibility to protect the public health is shared by the government, health professions, industry, and the public. The FDA's campaign on sodium is based on that shared responsibility. By improving communication and building upon their common objections, both pharmacy and the FDA can do their jobs successfully.

  11. Quality assurance in nuclear medicine facilities; availability of final recommendations--FDA. Notice.

    PubMed

    1985-05-13

    The Food and Drug Administration (FDA) is announcing the availability of final recommendations prepared by its Center for Devices and Radiological Health (CDRH) on quality assurance programs in nuclear medicine facilities. The final recommendations include the agency's rationale for the recommendations as well as references that can be used as well as references that can be used as guides in conducting quality control monitoring. These final recommendations are available as a technical report in CDRH's radiation recommendations series. They are intended to encourage and promote the development of voluntary quality assurance programs in nuclear medicine facilities. PMID:10271280

  12. Beyond biotechnology: FDA regulation of nanomedicine.

    PubMed

    Miller, John

    2003-01-01

    Nanotechnology, which involves investigating and manipulating matter at the atomic and molecular levels, may radically transform industry and society. Because nanotechnology could introduce whole new classes of materials and products, it could present an array of novel challenges to regulatory agencies. In this note, John Miller explores the regulatory challenges facing the Food and Drug Administration in regulating nanomedical products. First, the FDA will have trouble fitting the products into the agency's classification scheme. Second, it will be difficult for the FDA to maintain adequate scientific expertise in the field. He concludes that the FDA should consider implementing several reforms now to ensure that it is adequately prepared to regulate nanomedicine.

  13. Planning for effective interaction with FDA.

    PubMed

    Spurgin, Elizabeth A

    2004-12-01

    Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets.

  14. FDA's planning for radiological emergencies

    SciTech Connect

    Swick, C.

    1981-01-01

    The Three Mile Island accident pointed out a number of shortcomings in federal and state governmental planning for radiological emergencies. One concerns the handling of radiation-contaminated food. Pennsylvania, for example, has no legal limits for the amount of radionuclides permitted in food. An examination of the Food and Drug Administration's (FDA's) guidelines for the control of radiation-contaminated food which may be sold in interstate commerce concludes that only the Food, Drug and Cosmetic Act and one provision of the Atomic Energy Act are applicable; that the adulterated food section of the Act is not an effective means of barring the food from interstate commerce; and that the FDA has not established any regulations allowing it to condemn such food as required by the Act. 98 references.

  15. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

  16. FDA 101: Dietary Supplements

    MedlinePlus

    ... professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, ... the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports ...

  17. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ..., 2010 (75 FR 22599), FDA announced the availability of the draft guidance. Comments on the draft... the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS... Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.''...

  18. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... classification information.'' In the Federal Register of April 29, 2010 (75 FR 22601), FDA announced the...; User Fees for 513(g) Requests for Information; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; User Fees for...

  19. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a petition filed under § 60.30(a),...

  20. Doctors, drugs, and the FDA.

    PubMed

    Shanklin, D R

    1972-11-01

    This communication is directed to obstetricians, to the Food and Drug Administration (FDA), and to those individuals who might want to impose possibly unnecessary external structures on the practice of medicine. It is considered a positive that the patients of today are well informed and are more actively participating in therapeutic design. There is more veto power on the part of the patient and more concern over the trained ability of the physician. In the past physicians frequently made judgements individually, applying isolated and at times random standards for their decisions. Such actions were inevitable in an era when neither pathogenesis nor treatment was well understood. Now there is no excuse for such actions. Communication is easy, journals are widely circulated, and there are numerous refresher seminars. Increased specialization of knowledge has meant more corporate or group decisions for therapy. Current trends will continue to offer both opportunities and responsibilities. The opportunities are for better diffusion of knowledge, and the responsibility is to be informed. There can be a high level national standard for medical practice. As a beginning, the medical practice laws could use some uniform decisions. The FDA needs to show more responsiveness to changing knowledge and increased willingness to reconsider indications and contraindications in the light of newer experience. There is sufficient information available now to support the revocation of the approval of the use of diuretics in the management of human pregnancy. Another role of the FDA is the approval of new substances or new uses of old substances. The prostaglandins appear in this category, and the December 1972 issue will include the recent Brook Lodge Symposium on prostaglandins. The individual physician requires journal articles, individual experience, and designed trials in order to make judgements on patients who may have some factors not accounted for by groupthink or regulations

  1. 78 FR 13072 - Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... HUMAN SERVICES Food and Drug Administration Seventh Annual Drug Information Association/Food and Drug... Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA... INFORMATION CONTACT: Constance Burnett, Drug Information Association, 800 Enterprise Rd., Horsham, PA 19044,...

  2. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance... Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff...

  3. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives...

  4. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives...

  5. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives...

  6. FDA Regulates Tobacco Maps and Data of Model-Based Small Area Estimates - Small Area Estimates

    Cancer.gov

    FDA Regulates Tobacco is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

  7. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 10, 2010 (75 FR 32952), FDA announced... Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This guidance provides written guidance...

  8. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device... Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device.'' The recommendations in this...

  9. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... Tobacco to Protect Children and Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil...

  10. FDA Compliance Program Guidance Manual. Section VI. Radiological health

    SciTech Connect

    Not Available

    1981-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration field operations for project implementation.

  11. FDA OKs Non-Prescription Use of Acne Drug

    MedlinePlus

    ... 159779.html FDA OKs Non-Prescription Use of Acne Drug Differin Gel 0.1% is first retinoid ... July 8, 2016 (HealthDay News) -- Good news for acne sufferers: The U.S. Food and Drug Administration has ...

  12. NCI Director Also to Be Interim FDA Commissioner

    Cancer.gov

    Andrew von Eschenbach, M.D., director of the NCI, was asked by President Bush on Friday, September 23, 2005, to assume the additional role of interim Commissioner of the U.S. Food and Drug Administration (FDA).

  13. Epidural steroid warning controversy still dogging FDA.

    PubMed

    Manchikanti, Laxmaiah; Candido, Kenneth D; Singh, Vijay; Gharibo, Christopher G; Boswell, Mark V; Benyamin, Ramsin M; Falco, Frank J E; Grider, Jay S; Diwan, Sudhir; Hirsch, Joshua A

    2014-01-01

    On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as

  14. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

  15. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    .... Conduct two food product tracing pilot projects--one in coordination with the processed food sector and... points of service; 6. Demonstrate the tracking and tracing of: (a) A selected processed food and its key... HUMAN SERVICES Food and Drug Administration Implementation of the FDA Food Safety Modernization...

  16. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken 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), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

  17. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379... GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  18. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

  19. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How long may FDA detain an article of food? 1.379... GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  20. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379... GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  1. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

  2. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  3. Mini Lessons from FDA.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHEW), Washington, DC.

    Eight self-contained lessons present information about topics of current interest in the Food and Drug Administration. Multidisciplinary in nature, the lessons can be integrated into ongoing activities in elementary or secondary level reading, math, language arts, social studies, science, art, health, consumer education, and home economics. The…

  4. Regulatory Underpinnings of Global Health Security: FDA's Roles in Preventing, Detecting, and Responding to Global Health Threats

    PubMed Central

    Bond, Katherine C.; Maher, Carmen

    2014-01-01

    In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas—antimicrobial resistance, food safety, and supply chain integrity—in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats. PMID:25254912

  5. Regulatory underpinnings of Global Health security: FDA's roles in preventing, detecting, and responding to global health threats.

    PubMed

    Courtney, Brooke; Bond, Katherine C; Maher, Carmen

    2014-01-01

    In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats. PMID:25254912

  6. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

    PubMed

    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. PMID:27373012

  7. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

    PubMed

    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.

  8. Avanti overcomes safety concerns raised by FDA.

    PubMed

    1995-02-01

    As an alternative to the latex condom, the Avanti polyurethane condom represents the first technological breakthrough in the condom industry in 70 years. The manufacturer, London International in Florida, claims to have spent $16 million developing this condom. Although the US Food and Drug Administration (FDA) determined that the condom is safe, it questioned test results showing that the polyurethane material did not biodegrade under relatively mild conditions. Therefore, the FDA required the company to perform additional animal toxicity studies, which showed that the product was safe for rabbits. This was necessary because certain polyurethanes when degrading in mild conditions release a known carcinogen and a potential toxin. Canadian officials are also reviewing Avanti for approval; Canada does not have standards for plastic condoms either. The co-inventor of the Avanti condom said in San Diego that the toxicity studies had been conducted to satisfy the FDA, and there were no indications that the polyurethane condom could cause cancer or other adverse reactions. However, one study was located in the literature linking asthma and contact dermatitis to substances released from polyurethane chemicals. Another issue was the silicone used as the lubricant for the condom. Long-term exposure to silicone is still debated, but moderate amounts are harmless, according a Canadian official. The manufacturers are also considering providing Avanti with the nonoxynol-9 spermicide, which would need FDA approval. The safety of the Avanti's retention ring was also questioned. It is a rubber-based elastomer used for nonallergenic gloves, safe for people with allergies. In addition, polyurethane is not susceptible to ozone and oxidation, and its shelf life is three years, although it remains stable up to five years, according to durability tests. PMID:12290715

  9. 21 CFR 530.24 - Procedure for announcing analytical methods for drug residue quantification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Procedure for announcing analytical methods for...-Producing Animals § 530.24 Procedure for announcing analytical methods for drug residue quantification. (a) FDA may issue an order announcing a specific analytical method or methods for the quantification...

  10. 14 CFR 1260.8 - Announcements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Announcements. 1260.8 Section 1260.8 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS General § 1260.8 Announcements. Announcements for grants and cooperative agreements shall use the...

  11. 14 CFR 1260.8 - Announcements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Announcements. 1260.8 Section 1260.8 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS General § 1260.8 Announcements. Announcements for grants and cooperative agreements shall use the...

  12. 14 CFR § 1260.8 - Announcements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Announcements. § 1260.8 Section § 1260.8 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS General § 1260.8 Announcements. Announcements for grants and cooperative agreements shall use the...

  13. 14 CFR 1260.8 - Announcements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Announcements. 1260.8 Section 1260.8 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS General § 1260.8 Announcements. Announcements for grants and cooperative agreements shall use the...

  14. 14 CFR 1260.8 - Announcements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Announcements. 1260.8 Section 1260.8 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION GRANTS AND COOPERATIVE AGREEMENTS General § 1260.8 Announcements. Announcements for grants and cooperative agreements shall use the...

  15. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What expedited procedures apply when FDA initiates... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  16. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What expedited procedures apply when FDA initiates... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  17. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What expedited procedures apply when FDA initiates... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  18. Philip Morris' FDA gambit: good for public health?

    PubMed

    Givel, Michael

    2005-12-01

    The objective of this study was to determine whether the 2004 USA Dewine-Kennedy Bill is congruent with Philip Morris' core policy principles for United States Food and Drug Administration (FDA) regulation of tobacco and what impact that would have on the public health. I compared the Dewine-Kennedy Bill with 1999 Philip Morris core policy principles for FDA regulation. Additional supporting data on FDA regulation from 1998 to the present were collected from previously secret tobacco industry documents, relevant newspaper reports from Nexis-Lexis, federal statutes, and federal regulations. The main outcome measure of the study is a comparison, summary, and analysis of the Dewine-Kennedy Bill with Philip Morris' core principles for FDA regulation, and the result is that the Dewine-Kennedy Bill is compatible with almost all of Philip Morris' core principles on FDA regulation. In conclusion, The Dewine-Kennedy Bill, at best, was mixed in terms of the enhancement of the public health. On the one hand, proponents of this legislation argued stronger FDA regulatory requirements would have some effect on reducing youth and adult tobacco consumption. On the other hand, tobacco products would have remained a politically and economically viable and legal product consumed by millions of Americans many of whom would have continued to suffer from tobacco-related illnesses and deaths.

  19. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... 8, 2013 (78 FR 9396), FDA announced the availability of the draft guidance of the same title. FDA...; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability... (FDA) is announcing the availability of the guidance entitled ``Civil Money Penalties for...

  20. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products

  1. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  2. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  3. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  4. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  5. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  6. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  7. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Drugs Intended to Treat Life-threatening...

  8. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  9. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  10. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  11. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy.,...

  12. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy.,...

  13. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy.,...

  14. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  15. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  16. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  17. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products. PMID:27668042

  18. FDA Warns About Stem Cell Claims

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA Warns About Stem Cell Claims Share Tweet Linkedin Pin it More sharing ... blood-forming system. back to top Regulation of Stem Cells FDA regulates stem cells in the U.S. to ...

  19. FDA Approves New Weight-Loss Device

    MedlinePlus

    ... gov/news/fullstory_159362.html FDA Approves New Weight-Loss Device Surgically implanted port allows obese patients to ... have been unable to lose weight and maintain weight loss using nonsurgical treatments. The FDA approval is for ...

  20. CHALLENGES AND OPPORTUNITIES IN DRUG AND BIOMARKER DEVELOPMENT FOR NONALCOHOLIC STEATOHEPATITIS: FINDINGS AND RECOMMENDATIONS FROM AN AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES (AASLD) - FOOD AND DRUG ADMINISTRATION (FDA) JOINT WORKSHOP

    PubMed Central

    Sanyal, Arun J.; Friedman, Scott L.; McCullough, Arthur J.; Dimick, Lara

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in North America. It is a growing contributor to the burden of chronic liver disease requiring liver transplantation. Cirrhosis is also associated with an increased risk of hepatocellular cancer which may occur even in the absence of cirrhosis in subjects with nonalcoholic steatohepatitis (NASH) the histological form of NAFLD associated with increased liver-related mortality. The diagnosis of NASH currently requires a liver biopsy. There are also no FDA-approved therapies for NASH. There is therefore a need to develop better diagnostic and therapeutic strategies for patients with NASH targeting both those with early stage disease as well as those with advanced liver fibrosis. There are unique challenges in the design of studies for these target populations. The long relatively asymptomatic time interval in the progression of NAFLD and NASH to cirrhosis and ultimately liver failure, along with gaps in knowledge regarding disease modifiers combine to present significant challenges in trial design. There is therefore an urgent need to develop methods to identify the populations at particular risk of disease progression and to validate endpoints that reflect meaningful changes in health status in this population. This manuscript summarizes the discussion at a joint workshop held September 5th and 6th, 2013, in Silver Spring, Maryland, sponsored by the FDA and the AASLD to develop guidance on diagnostic and therapeutic modalities for NASH. PMID:25557690

  1. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... regulated firms to conduct recalls. Variables in the type of products, the quantity and level of... Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... reporting requirements on FDA recalls. DATES: Submit either electronic or written comments on the...

  2. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  3. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  4. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  5. FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers, 2000.

    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…

  6. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false When does FDA have to issue a decision on an... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

  7. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  8. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false When does FDA have to issue a decision on an... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

  9. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and revises the March 2007 guidance entitled ``Drug Safety Information-- FDA's Communication to the Public.''...

  10. Healthy public relations: the FDA's 1930s legislative campaign.

    PubMed

    Kay, G

    2001-01-01

    In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more. PMID:11568487

  11. 78 FR 56906 - Announcement of the Award of Three Single-Source Program Expansion Supplement Grants to National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... HUMAN SERVICES Administration for Children and Families Office of Refugee Resettlement Announcement of... Victim Assistance Program Grantees AGENCY: Office of Refugee Resettlement, ACF, HHS. ACTION: Announcement...: The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces...

  12. Obama Administration Announces Ocean Policy

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2010-08-01

    With the U.S. Interagency Ocean Policy Task Force final report in hand, U.S. president Barack Obama issued an executive order on 19 July largely adopting its recommendations. These include establishing a National Policy for the Stewardship of the Ocean, Coasts, and Great Lakes; creating a National Ocean Council, which will hold its first meeting later this summer; strengthening the ocean governance structure; and providing for the development of coastal and marine spatial plans. The task force report indicates that U.S. ocean policy includes protecting, maintaining, and restoring ocean, coastal, and Great Lakes ecosystems and resources; increasing scientific understanding and using the best available science and knowledge to inform decisions about them; and improving the understanding and awareness of changing environmental conditions.

  13. News & Announcements

    NASA Astrophysics Data System (ADS)

    2001-08-01

    News from Journal House

    National Chemistry Week (NCW)

    National Chemistry Week Celebrating Chemistry and Art is the theme of NCW 2001, to be held November 4-10, 2001. As you make plans for participating in the celebrations in your area, keep in mind that JCE is developing special materials on this theme, which will appear in our October issue: Classroom Activities, a comprehensive Illustrated Resource Paper, Report from Online, specially written brief articles illustrated in color, articles related to the theme, and CLIPs (Chemical Laboratory Information Profiles).

    Awards Announced

    Passer Award

    Passer Award recipients from the April 1 closing date are:
    • George Bennett, Millikin University, Decatur, IL
    • Daniel Berger, Bluffton College, Bluffton, OH
    • Karen Dunlap, Sierra College, Rocklin, CA
    • Myung-Hoon Kim, Georgia Perimeter College, Dunwoody, GA
    • Cheryl Longfellow, Philadelphia University, Philadelphia, PA
    • Jerry Maas, Oakton Community College, Des Plaines, IL
    • Tim Royappa, University of West Florida, Pensacola, FL

    Visiting Scientist Award, Western Connecticut Section

    Diane Bunce, The Catholic University of America, has been selected as the 2001 Visiting Scientist of the Western Connecticut Section of the ACS. The award, presented annually since 1967, brings an outstanding chemical educator to visit high schools in Fairfield County, CT. In May, Bunce visited three high schools, Christian Heritage School, Fairfield High School, and Greenwich High School, where she interacted with teachers and students and presented lectures and demonstrations to several chemistry classes. She was also keynote speaker at the ACS local section's Education Night. The awardee is selected by a committee of university and high school teachers, industrial chemists, and the previous Visiting Scientist

  14. FDA compliance program guidance manual (FY 83). section VI. radiological health

    SciTech Connect

    Not Available

    1982-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration field operations for project implementation.

  15. Network analysis of FDA approved drugs and their targets.

    PubMed

    Ma'ayan, Avi; Jenkins, Sherry L; Goldfarb, Joseph; Iyengar, Ravi

    2007-04-01

    The global relationship between drugs that are approved for therapeutic use and the human genome is not known. We employed graph-theory methods to analyze the Federal Food and Drug Administration (FDA) approved drugs and their known molecular targets. We used the FDA Approved Drug Products with Therapeutic Equivalence Evaluations 26(th) Edition Electronic Orange Book (EOB) to identify all FDA approved drugs and their active ingredients. We then connected the list of active ingredients extracted from the EOB to those known human protein targets included in the DrugBank database and constructed a bipartite network. We computed network statistics and conducted Gene Ontology analysis on the drug targets and drug categories. We find that drug to drug-target relationship in the bipartite network is scale-free. Several classes of proteins in the human genome appear to be better targets for drugs since they appear to be selectively enriched as drug targets for the currently FDA approved drugs. These initial observations allow for development of an integrated research methodology to identify general principles of the drug discovery process. PMID:17516560

  16. FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys | Division of Cancer Prevention

    Cancer.gov

    The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |

  17. The FDA and genetic testing: improper tools for a difficult problem

    PubMed Central

    Willmarth, Kirk

    2015-01-01

    The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.

  18. 14 CFR 1214.1101 - Announcement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Announcement. 1214.1101 Section 1214.1101 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate Recruitment and Selection Program § 1214.1101 Announcement. (a) Astronaut candidate opportunities Will...

  19. 14 CFR 1214.1101 - Announcement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Announcement. 1214.1101 Section 1214.1101 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate Recruitment and Selection Program § 1214.1101 Announcement. (a) Astronaut candidate opportunities Will...

  20. 14 CFR 1214.1101 - Announcement.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Announcement. 1214.1101 Section 1214.1101 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate Recruitment and Selection Program § 1214.1101 Announcement. (a) Astronaut candidate opportunities Will...

  1. 14 CFR § 1214.1101 - Announcement.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Announcement. § 1214.1101 Section § 1214.1101 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate Recruitment and Selection Program § 1214.1101 Announcement. (a) Astronaut candidate...

  2. Contrary Signals from the FDA.

    ERIC Educational Resources Information Center

    Meyer, Katherine A.; Schultz, William B.

    1984-01-01

    The Reagan administration has taken numerous regulatory actions which are flatly inconsistent with the President's stated political philosophy. Nowhere is this more evident than at the Food and Drug Administration in areas concerning abortion, generic drugs, the denial of information, and medical devices. (RM)

  3. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... HUMAN SERVICES Food and Drug Administration FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. SUMMARY: As...

  4. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal.

    PubMed

    1998-08-27

    The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

  5. Administrative Actions for Noncompliance; Lesser Administrative Actions. Direct final rule.

    PubMed

    2016-04-01

    The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.

  6. FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.

    PubMed

    Welle, Cristin; Krauthamer, Victor

    2012-03-01

    The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4].

  7. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance...; The Content of Investigational Device Exemption and Premarket Approval Applications for...

  8. 48 CFR 1835.016-71 - NASA Research Announcements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true NASA Research Announcements... ADMINISTRATION SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1835.016-71 NASA Research Announcements. (a) Scope. An NRA is used to announce research interests in support of NASA's programs,...

  9. Ensuring that consumers receive appropriate information from drug ads: what is the FDA's role?

    PubMed

    Waxman, Henry A

    2004-01-01

    The promise of direct-to-consumer (DTC) prescription drug advertisements lies in their potential to educate consumers about medical conditions and the possibility of treatment. But this promise can only be fulfilled if consumers are given clear and accurate information. The responsibility for ensuring that this occurs falls on the Food and Drug Administration (FDA). Recent congressional investigations have indicated that the agency is failing at this task, as FDA enforcement actions against false and misleading ads have declined precipitously in recent years. Other FDA efforts, such as its recently released guidelines on prescription drugs, do not appear to be helpful, potentially confusing consumers more than helping them. PMID:15452002

  10. An analysis of FDA passive surveillance reports of seizures associated with consumption of aspartame.

    PubMed

    Tollefson, L; Barnard, R J

    1992-05-01

    Aspartame, the methyl ester of the dipeptide formed from combining phenylalanine and aspartic acid, was approved by the US Food and Drug Administration (FDA) in July 1981. FDA monitors complaints from consumers and health professionals through the Adverse Reaction Monitoring System, a passive surveillance program FDA has received 251 reports of seizures that have been linked to ingestion of aspartame by consumers. In most cases, information obtained from the complainants' medical records as well as data on consumption patterns, temporal relationships, and challenge tests did not support the claim that the occurrences of the seizures were linked to consumption of aspartame.

  11. Science, law, and politics in FDA's genetically engineered foods policy: scientific concerns and uncertainties.

    PubMed

    Pelletier, David L

    2005-06-01

    The Food and Drug Administration's (FDA's) 1992 policy statement granted genetically engineered foods presumptive GRAS (generally recognized as safe) status. Since then, divergent views have been expressed concerning the scientific support for this policy. This paper examines four sources to better understand the basis for these claims: 1) internal FDA correspondence; 2) reports from the National Academy of Sciences; 3) research funded by US Department of Agriculture from 1981 to 2002; and 4) FDA's proposed rules issued in 2001. These sources reveal that little research has been conducted on unintended compositional changes from genetic engineering. Profiling techniques now make this feasible, but the new debate centers on the functional meaning of compositional changes.

  12. United States FDA's emergency use authorization of Ebola virus diagnostics: current impact and lessons for the future.

    PubMed

    Whitehouse, Chris A; Bavari, Sina; Perkins, Mark D

    2015-01-01

    The Ebola outbreak that took hold in West Africa in 2014 outran the epidemic response capacity of many organizations. Five months after the epidemic was first declared, there were still only two laboratories in West Africa with the capacity to confirm Ebola virus infection. In the summer of 2014, before the first case of imported Ebola occurred in the USA, the US FDA announced it would issue Emergency Use Authorizations for Ebola virus in vitro diagnostics to speed their availability. Between October 2014 and March 2015, the FDA issued Emergency Use Authorizations for nine diagnostic products. The actions of the FDA not only allowed nationwide deployment of Ebola virus testing capacity in the USA but also established an attractive regulatory goalpost for companies developing assays for use in West Africa. Here, we comment on the diagnostic assays for which the FDA has issued emergency authorizations and their fitness for purpose. PMID:26394699

  13. 76 FR 43688 - Announcement of Expansion Supplement Grant Awards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... HUMAN SERVICES Administration for Children and Families Announcement of Expansion Supplement Grant.... SUMMARY: The Administration for Children and Families (ACF), Administration for Native Americans (ANA..., grantee Tribes have set forth goals and milestones that will benefit Native youth, children, and...

  14. News & Announcements

    NASA Astrophysics Data System (ADS)

    2000-01-01

    /TD/TDhome.html. This site also has links to JCE guidelines for prospective authors. Volunteers should contact Vitz by the medium of their preference: Ed Vitz, Editor, Tested Demonstrations, Journal of Chemical Education, Department of Chemistry, Kutztown University, Kutztown, PA 19530; phone: 610/683-4443; fax: 610/683-1352; email: vitz@kutztown.edu.

    Awards Announced

    ACS Regional Awards in High School Chemistry Teaching The American Chemical Society has announced winners of regional awards in high school chemistry teaching for 1999. Winners have demonstrated excellence in teaching, exceptional ability to challenge and inspire students, extracurricular work, and willingness to keep up to date in the field. The award consists of two certificates (one for the recipient, the other for display at the recipient's school) and a cash prize of 1,000.
    • Thomas W. Adams, Indiana Academy for Science, Mathematics & Humanities at Ball State University, Muncie, Indiana: Central Region
    • Arthur J. Crumm, Barstow School, Kansas City, Missouri: Midwest Region
    • Esther H. Freeman, Tabb High School, Yorktown, Virginia: Southeast Region
    • Joan A. Laredo-Liddell, St. Barnabas High School, Bronx, New York: Middle Atlantic Region, 1998
    • David T. Lee, Mountain Lakes High School, Mountain Lakes, New Jersey: Middle Atlantic Region, 1999
    • Diane Coley McGann, Santa Ana High School, Santa Ana, California: Western Region
    • William J. Pilotte, Newington High School, Newington, Connecticut: Northeast Region
    • Judith C. Seydel, Idaho Falls High School, Idaho Falls, Idaho: Northwest Region
    • Brenda A. Wolpa, Canyon Del Oro High School, Tucson, Arizona: Southwest/Rocky Mountain Region
    NSF Distinguished Public Service Award As a part of its celebration in 2000 of its half-century in existence, the National Science Foundation has announced the recipient of its Distinguished Public Service Aw

  15. News & Announcements

    NASA Astrophysics Data System (ADS)

    2001-08-01

    News from Journal House

    National Chemistry Week (NCW)

    National Chemistry Week Celebrating Chemistry and Art is the theme of NCW 2001, to be held November 4-10, 2001. As you make plans for participating in the celebrations in your area, keep in mind that JCE is developing special materials on this theme, which will appear in our October issue: Classroom Activities, a comprehensive Illustrated Resource Paper, Report from Online, specially written brief articles illustrated in color, articles related to the theme, and CLIPs (Chemical Laboratory Information Profiles).

    Awards Announced

    Passer Award

    Passer Award recipients from the April 1 closing date are:
    • George Bennett, Millikin University, Decatur, IL
    • Daniel Berger, Bluffton College, Bluffton, OH
    • Karen Dunlap, Sierra College, Rocklin, CA
    • Myung-Hoon Kim, Georgia Perimeter College, Dunwoody, GA
    • Cheryl Longfellow, Philadelphia University, Philadelphia, PA
    • Jerry Maas, Oakton Community College, Des Plaines, IL
    • Tim Royappa, University of West Florida, Pensacola, FL

    Visiting Scientist Award, Western Connecticut Section

    Diane Bunce, The Catholic University of America, has been selected as the 2001 Visiting Scientist of the Western Connecticut Section of the ACS. The award, presented annually since 1967, brings an outstanding chemical educator to visit high schools in Fairfield County, CT. In May, Bunce visited three high schools, Christian Heritage School, Fairfield High School, and Greenwich High School, where she interacted with teachers and students and presented lectures and demonstrations to several chemistry classes. She was also keynote speaker at the ACS local section's Education Night. The awardee is selected by a committee of university and high school teachers, industrial chemists, and the previous Visiting Scientist

  16. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Implementation of the Fee... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  17. 77 FR 70955 - FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 FDA Actions Related to Nicotine Replacement... public on FDA consideration of applicable approval mechanisms and additional indications for nicotine..., including nicotine-containing gums, patches, and lozenges, are already marketed for smoking cessation....

  18. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to improve focus ... 2016 (HealthDay News) -- An implant that helps the aging eye focus on small print and nearby objects ...

  19. Traumatic Brain Injury: FDA Research and Actions

    MedlinePlus

    ... For Consumers Home For Consumers Consumer Updates Traumatic Brain Injury: FDA Research and Actions Share Tweet Linkedin ... top What to Do if You Suspect Traumatic Brain Injury Anyone with signs of moderate or severe ...

  20. FDA Approves First Immunotherapy for Lymphoma

    Cancer.gov

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  1. FDA Warns Ovarian Cancer Tests Not Reliable

    MedlinePlus

    ... medlineplus.gov/news/fullstory_160880.html FDA Warns Ovarian Cancer Tests Not Reliable May delay preventive therapies for ... Sept. 9, 2016 (HealthDay News) -- Screening tests for ovarian cancer are not reliable and should not be used, ...

  2. FDA Bolsters Warnings about Class of Antibiotics

    MedlinePlus

    ... 160078.html FDA Bolsters Warnings About Class of Antibiotics Fluoroquinolones such as Cipro, Levaquin should be reserved ... it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to ...

  3. FDA Expands Advice on Statin Risks

    MedlinePlus

    ... of liver damage. back to top Reports of Memory Loss FDA has been investigating reports of cognitive ... included assessments of cognitive function. The reports about memory loss, forgetfulness and confusion span all statin products ...

  4. Drug Advertising and the FDA.

    ERIC Educational Resources Information Center

    Levesque, Cynthia

    With increases in consumer focused advertising for prescription drugs, the Federal Drug Administration has renewed efforts to protect the public from false advertising. In 1982, it charged that the press kits Eli Lilly and Company distributed to reporters on its new antiarthritis drug, Oraflex, misrepresented the product. It recommended that Lilly…

  5. Publisher's Announcement

    NASA Astrophysics Data System (ADS)

    Scriven, Neil

    2003-12-01

    We are delighted to announce that the new Editor-in-Chief of Journal of Physics A: Mathematical and General for 2004 will be Professor Carl M Bender of Washington University, St. Louis. Carl will, with the help of his world class editorial board, maintain standards of scientific rigour whilst ensuring that research published is of the highest importance. Carl attained his first degree in physics at Cornell University before studying for his PhD at Harvard. He later worked at The Institute for Advanced Study in Princeton and at MIT before assuming his current position at Washington University, St Louis. He has been a visiting professor at Technion, Haifa, and Imperial College, London and a scientific consultant for Los Alamos National Laboratory. His main expertise is in using classical applied mathematics to solve a broad range of problems in high-energy theoretical physics and mathematical physics. Since the publication of his book Advanced Mathematical Methods for Scientists and Engineers, written with Steven Orszag, he has been regarded as an expert on the subject of asymptotic analysis and perturbative methods. `Carl publishes his own internationally-important research in the journal and has been an invaluable, energetic member of the Editorial Board for some time' said Professor Ed Corrigan, Carl's predecessor as Editor, `he will be an excellent Editor-in-Chief'. Our grateful thanks and best wishes go to Professor Corrigan who has done a magnificent job for the journal during his five-year tenure.

  6. News & Announcements

    NASA Astrophysics Data System (ADS)

    2000-02-01

    . Chem. Educ. 1998, 75, 1432A (November 1998). Workshop?yes Booth?could show properties of pre-made gluep Notes:Need access to water. Can be messy. People usually enjoy the activity. Works well. Activity:CD Light: An Introduction to Spectroscopy. J. Chem. Educ. 1998, 75, 1568A (December 1998). Workshop?yes Booth?yes, with colored plastic onlynot solutions Notes:Can be difficult to measure and cut cardboard for spectroscope. Pre-made spectroscopes and partially constructed ones to show method could be provided. Needs good light source to work well. Activity:Cleaning Up with Chemistry: Investigating the Action of Zeolite in Laundry Detergent. J. Chem. Educ. 1999, 76, 1461A (October 1999). Workshop?yes Booth?could demonstrate tubes of soapy water with and without zeolite Notes:Need access to water. Quick and easy. More information about JCE Classroom Activities is available on JCE Online at: http://jchemed.chem.wisc.edu/AboutJCE/Features/JCE_CA/. Here you will find the notes described above and a list of all published Classroom Activities. The site is updated regularly.

    Awards Announced

    United Nations Environment Program The United Nations Environment Program (UNEP) has selected Mario J. Molina, professor of earth, atmosphere, and planetary sciences at Massachusetts Institute of Technology, as the winner of the 1999 UNEP Sasakawa Environment Prize. The prize, worth $200,000, is for his outstanding global contributions in the field of atmospheric chemistry. ACS Northeastern Section The Northeastern Section of the American Chemical Society has awarded the Henry A. Hill Award to Morton Z. Hoffman, professor of chemistry at Boston University. The award is given annually to a member of the section for outstanding service.

    Award Deadlines

    Mettler-Toledo Thermal Analysis Education Grant Mettler-Toledo has established a grant to honor Edith A. Turi of the Polymer Research Institute, Polytechnic University, Brooklyn, NY, for her lifelong contribution to the cause

  7. FDA use of international standards in the premarket review process.

    PubMed

    Rechen, E; Barth, D J; Marlowe, D; Kroger, L

    1998-01-01

    "This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European

  8. Revisiting Financial Conflicts of Interest in FDA Advisory Committees

    PubMed Central

    Pham-Kanter, Genevieve

    2014-01-01

    Context The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members’ financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. Methods The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997–2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members’ financial interests and their voting behavior. Findings Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). Conclusions There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial

  9. Catching Up on New Medications: New FDA Approvals.

    PubMed

    Turkoski, Beatrice B

    2016-01-01

    Despite all efforts of the Federal Drug Administration to release timely and accurate information about new drug approvals, marketing and media announcements about new drugs may be incomplete, misinterpreted, or misunderstood. Informed and knowledgeable nurses are able to educate patients about new medications: they can clarify misunderstandings or misconceptions and significantly reduce the potential for harm. In this article, selected examples of new brand name drugs and first-time generics approved this year are discussed. PMID:26814007

  10. Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.

    PubMed

    Yim, Seon-Hee; Chung, Yeun-Jun

    2014-12-01

    In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing. PMID:25705152

  11. The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

    PubMed Central

    Wittes, Janet; Crowe, Brenda; Chuang-Stein, Christy; Guettner, Achim; Hall, David; Jiang, Qi; Odenheimer, Daniel; Xia, H. Amy; Kramer, Judith

    2015-01-01

    In March 2011, a Final Rule for expedited reporting of serious adverse events took effect in the United States for studies conducted under an Investigational New Drug (IND) application. In December 2012, the U.S. Food and Drug Administration (FDA) promulgated a final Guidance describing the operationalization of this Final Rule. The Rule and Guidance clarified that a clinical trial sponsor should have evidence suggesting causality before defining an unexpected serious adverse event as a suspected adverse reaction that would require expedited reporting to the FDA. The Rule's emphasis on the need for evidence suggestive of a causal relation should lead to fewer events being reported but, among those reported, a higher percentage actually being caused by the product being tested. This article reviews the practices that were common before the Final Rule was issued and the approach the New Rule specifies. It then discusses methods for operationalizing the Final Rule with particular focus on relevant statistical considerations. It concludes with a set of recommendations addressed to Sponsors and to the FDA in implementing the Final Rule. PMID:26550466

  12. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Affecting the Hematopoietic System.'' That draft guidance, when finalized, is intended to supersede the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  13. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  14. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  15. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

  16. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

  17. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

  18. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention order? 1.393 Section 1.393 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...

  19. Addressing the evidence for FDA nicotine replacement therapy label changes: a policy statement of the Association for the Treatment of Tobacco use and Dependence and the Society for Research on Nicotine and Tobacco.

    PubMed

    Fucito, Lisa M; Bars, Matthew P; Forray, Ariadna; Rojewski, Alana M; Shiffman, Saul; Selby, Peter; West, Robert; Foulds, Jonathan; Toll, Benjamin A

    2014-07-01

    Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation. PMID:24919399

  20. News & Announcements

    NASA Astrophysics Data System (ADS)

    2000-01-01

    /TD/TDhome.html. This site also has links to JCE guidelines for prospective authors. Volunteers should contact Vitz by the medium of their preference: Ed Vitz, Editor, Tested Demonstrations, Journal of Chemical Education, Department of Chemistry, Kutztown University, Kutztown, PA 19530; phone: 610/683-4443; fax: 610/683-1352; email: vitz@kutztown.edu.

    Awards Announced

    ACS Regional Awards in High School Chemistry Teaching The American Chemical Society has announced winners of regional awards in high school chemistry teaching for 1999. Winners have demonstrated excellence in teaching, exceptional ability to challenge and inspire students, extracurricular work, and willingness to keep up to date in the field. The award consists of two certificates (one for the recipient, the other for display at the recipient's school) and a cash prize of 1,000.
    • Thomas W. Adams, Indiana Academy for Science, Mathematics & Humanities at Ball State University, Muncie, Indiana: Central Region
    • Arthur J. Crumm, Barstow School, Kansas City, Missouri: Midwest Region
    • Esther H. Freeman, Tabb High School, Yorktown, Virginia: Southeast Region
    • Joan A. Laredo-Liddell, St. Barnabas High School, Bronx, New York: Middle Atlantic Region, 1998
    • David T. Lee, Mountain Lakes High School, Mountain Lakes, New Jersey: Middle Atlantic Region, 1999
    • Diane Coley McGann, Santa Ana High School, Santa Ana, California: Western Region
    • William J. Pilotte, Newington High School, Newington, Connecticut: Northeast Region
    • Judith C. Seydel, Idaho Falls High School, Idaho Falls, Idaho: Northwest Region
    • Brenda A. Wolpa, Canyon Del Oro High School, Tucson, Arizona: Southwest/Rocky Mountain Region
    NSF Distinguished Public Service Award As a part of its celebration in 2000 of its half-century in existence, the National Science Foundation has announced the recipient of its Distinguished Public Service Award.
    • Samuel P. Massie, U.S. Naval Academy

  1. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis

    PubMed Central

    Wang, Bo; Franklin, Jessica M.; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron S.

    2016-01-01

    Background Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved (“off-label”) uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. Methods Retrospective, segmented time-series analysis using new prescription claims during 2003–2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone). FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone. Results During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications). Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63). Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79). Conclusions The FDA’s sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency’s expert judgments to clinical practice. PMID:27032095

  2. 2015 in review: FDA approval of new drugs.

    PubMed

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise. PMID:27109618

  3. The new label for erythropoiesis stimulating agents: the FDA'S sentence.

    PubMed

    Fishbane, Steven; Jhaveri, Kenar D

    2012-05-01

    On June 24, 2011, the U.S. Food and Drug Administration (FDA) revised the prescribing instructions (the label) for erythropoiesis-stimulating agents. The new label, the second revision since publication of the TREAT Study, placed new restrictions on the use of these agents, and increased the strength of warnings. We believe that the new label language may deprive patients of the full benefits of erythropoiesis-stimulating agent treatment and impair the opportunity to individualize treatment through shared decision making. Diminished discovery and innovation in the treatment of one of the most common and important complications of kidney disease may also be an unintended consequence of the label change. PMID:22515844

  4. FDA's Laser Notice 50: a step toward global harmonization

    NASA Astrophysics Data System (ADS)

    Kent, Suzie L. B.; Dennis, Jerome E.; Zaharek, Gary L.; Eng, Francis J.

    2003-06-01

    The US Food and Drug Administration, Center of Devices and Radiological Health issued Laser Notice 50 in July 2001. This Notice is a preliminary step that FDA has taken to harmonize US regulations for laser products (21 Code of Federal Regulations) with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products. The paper discusses rationale for the changes and describes some of the implementation issues, including comparisons between the current standards. The impact on the regulated industry and the user community is that the same laser hazard classification scheme is used and that engineered safety features are consistentin the world markets.

  5. News & Announcements

    NASA Astrophysics Data System (ADS)

    1999-09-01

    IP-Address subscription option for libraries and institutions. With this option, the library or institution provides us with a list of all IP numbers that will receive access. Any desktop computer using one of these IP numbers will have immediate access, without the prompt for name and password. Because this requires considerably more administrative work on our end, there is a somewhat larger (but reasonable) fee. Please make your librarian aware of this new option that will provide you and all your colleagues with desktop access to JCE. Immediate Access to Online At present new subscribers are not able to get immediate access to JCE Onlinea limitation for subscribers who order over the telephone using a credit card. We now have an arrangement with our subscription fulfillment agent to give new subscribers immediate access to JCE Online by a guest account. The temporary guest account information will be provided as a part of the telephone order; when the new account is active, the account information will be emailed. Remember to Provide Your Email Address Knowing your email address has become important for Journal communication. In addition to account information, we will send an order confirmation to each subscriber who provides an email address. For those who want it, we intend, in the near future, to send an email message announcing when each month's issue goes online. We do not sell or give email addresses to anyone else. Keeping Up to Date with JCE Online JCE Online will continue to change and expand, as the technology around us changes and as new features and columns are added. The best way to keep abreast of new developments is to look for the JCE Online column in both print and online. Jon Holmes, editor of JCE Online, uses this column to keep readers in touch with the latest happenings:

    • JCE Online FAQs (March 1999, p 446)
    • JCE Online 99 (April 1999, p 584)
    • JCE Feature

    • 10 CFR 903.11 - Advance announcement of rate adjustment.

      Code of Federal Regulations, 2013 CFR

      2013-01-01

      ... 10 Energy 4 2013-01-01 2013-01-01 false Advance announcement of rate adjustment. 903.11 Section... Western Area Power Administrations § 903.11 Advance announcement of rate adjustment. The Administrator may... advertisement, and/or by Federal Register publication. Written comments relevant to rate policy and design...

    • 10 CFR 903.11 - Advance announcement of rate adjustment.

      Code of Federal Regulations, 2012 CFR

      2012-01-01

      ... 10 Energy 4 2012-01-01 2012-01-01 false Advance announcement of rate adjustment. 903.11 Section... Western Area Power Administrations § 903.11 Advance announcement of rate adjustment. The Administrator may... advertisement, and/or by Federal Register publication. Written comments relevant to rate policy and design...

    • 10 CFR 903.11 - Advance announcement of rate adjustment.

      Code of Federal Regulations, 2011 CFR

      2011-01-01

      ... 10 Energy 4 2011-01-01 2011-01-01 false Advance announcement of rate adjustment. 903.11 Section... Western Area Power Administrations § 903.11 Advance announcement of rate adjustment. The Administrator may... advertisement, and/or by Federal Register publication. Written comments relevant to rate policy and design...

    • 10 CFR 903.11 - Advance announcement of rate adjustment.

      Code of Federal Regulations, 2010 CFR

      2010-01-01

      ... 10 Energy 4 2010-01-01 2010-01-01 false Advance announcement of rate adjustment. 903.11 Section... Western Area Power Administrations § 903.11 Advance announcement of rate adjustment. The Administrator may... advertisement, and/or by Federal Register publication. Written comments relevant to rate policy and design...

    • FDA approved drugs as potential Ebola treatments

      PubMed Central

      Ekins, Sean; Coffee, Megan

      2015-01-01

      In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available. PMID:25789163

    • News & Announcements

      NASA Astrophysics Data System (ADS)

      1999-08-01

      Chicago Section of the American Chemical Society. It is awarded annually to a world-renowned scientist selected by a jury of panelists composed of eminent chemists elected by the Board of Directors of the Chicago Section. The award was presented at the Chicago Section's meeting in May 1999. Courses, Seminars, Meetings, Opportunities Grant Program for Senior Scientist Mentors The Camille and Henry Dreyfus Foundation announces a new initiative within its Special Grant Program in the Chemical Sciences: the Senior Scientist Mentors. Undergraduate participation in research is generally acknowledged to be one of the most effective ways for students to learn and appreciate chemistry. Key to a meaningful research experience is the advising and counseling a student can receive from leaders in chemical research. Application Details Emeritus faculty who maintain active research programs in the chemical sciences may apply for one of a limited number of awards that will allow undergraduates to do research under their guidance. Successful applicants, who are expected to be closely engaged in a mentoring relationship with the students, will receive grants of 10,000 annually for two years (20,000 total) for undergraduate stipends and modest research support. In approximately three pages, applicants should describe their ongoing research and the nature of the participation by undergraduates in the research activity. The role of the applicant as mentor should be clearly outlined. The application should also contain a curriculum vitae of no more than five pages that includes representative publications; a letter of support from the department chair that also commits appropriate space and facilities for the undergraduate participants; and a letter of support from a colleague (preferably from outside the department) who is familiar with the applicant's research and teaching. This initiative is open to all institutions that offer bachelor's or higher degrees in the chemical sciences. Use the

    • No sisyphean task: how the FDA can regulate electronic cigarettes.

      PubMed

      Paradise, Jordan

      2013-01-01

      The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

    • No sisyphean task: how the FDA can regulate electronic cigarettes.

      PubMed

      Paradise, Jordan

      2013-01-01

      The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

    • FDA aprueba la primera inmunoterapia para linfoma

      Cancer.gov

      La FDA ha aprobado nivolumab (Opdivo®) para el tratamiento de pacientes con el linfoma clásico de Hodgkin que ha recaído o empeorado después de recibir un trasplante autólogo hematopoyético seguido de brentuximab vedotin (Adcetris®)

    • Nods for Atezolizumab and Nivolumab from FDA.

      PubMed

      2016-08-01

      The FDA has conditionally approved atezolizumab, the first PD-L1 inhibitor, for metastatic urothelial carcinoma, along with a companion diagnostic, the Ventana PD-L1 (SP142) assay. The agency has also expanded nivolumab's indications to include classical Hodgkin lymphoma, making this PD-1 inhibitor the first to be approved for a hematologic malignancy.

    • 76 FR 16630 - Announcement of an Award

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-03-24

      ... on hunger and obesity issues for young children. An award in the amount of $3,000 has been made to... HUMAN SERVICES Administration for Children And Families Announcement of an Award AGENCY: Office of Policy, Research and Evaluation, ACF, HHS. ACTION: The Administration for Children and Families...

    • Assessment of foetal risk associated with 93 non-US-FDA approved medications during pregnancy

      PubMed Central

      Al-jedai, Ahmed H.; Balhareth, Sakra S.; Algain, Roaa A.

      2012-01-01

      Health care practitioners utilize the United States-Food and Drug Administration (US-FDA) pregnancy categorization (A, B, C, D, X) for making decision on the appropriateness of certain medications during pregnancy. Many non US-FDA approved medications are registered and marketed in Saudi Arabia. However, these medications do not have an assigned pregnancy risk categorization like those approved in the US. The objective of this review is to evaluate, report, and categorize the foetal risk associated with non-US-FDA approved medications registered by the Saudi Food and Drug Authority (S-FDA) according to the US-FDA pregnancy risk categorization system. We identified 109 non-US-FDA approved medications in the Saudi National Formulary (SNF) as of October 2007. We searched for data on functional or anatomical birth defects or embryocidal-associated risk using different databases and references. An algorithm for risk assessment was used to determine a pregnancy risk category for each medication. Out of 93 eligible medications, 73% were assigned category risk C, 10 medications (11%) were assigned category risk D, and 12 medications (13%) were assigned category risk B. Only three medications were judged to be safe during pregnancy based on the available evidence and were assigned category risk A. Inconsistencies in defining and reporting the foetal risk category among different drug regulatory authorities could create confusion and affect prescribing. We believe that standardization and inclusion of this information in the medication package insert is extremely important to all health care practitioners. PMID:23960803

    • FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

      PubMed

      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. PMID:27068243

    • 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-04-01

      ..., 301-827-7010. SUPPLEMENTARY INFORMATION: FDA is amending its administrative regulations in 21 CFR part.... 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a) Regulations. FDA... Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA)...

    • 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-04-02

      ... and Tracing of Food'' that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the... Register of March 5, 2013 (78 FR 14309), FDA published a ] notice with a 30-day comment period to...

  1. 77 FR 14810 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cooperative Manufacturing Arrangements for Licensed Biologics...) is announcing that a collection of information entitled ``Cooperative Manufacturing Arrangements...

  2. 78 FR 19735 - Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... Employment and Training Administration. Announcement Regarding a Change in Eligibility for Unemployment..., South Carolina and Texas in the Emergency Unemployment Compensation 2008 (EUC08) Program, and the...: Notice. SUMMARY: Announcement regarding a change in eligibility for Unemployment Insurance (UI)...

  3. 78 FR 38074 - Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... Employment and Training Administration Announcement Regarding a Change in Eligibility for Unemployment... Virgin Islands and Wisconsin in the Emergency Unemployment Compensation 2008 (EUC08) Program, and the...: Notice. SUMMARY: Announcement regarding a change in eligibility for Unemployment Insurance (UI)...

  4. OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

    PubMed Central

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  5. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    PubMed

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  6. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation.

    PubMed

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-03-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  7. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false FDA recognition of exclusive marketing rights. 516.34 Section 516.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... for maintaining MUMS-designated drug exclusive marketing rights for the full 7-year term. This...

  8. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  9. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  10. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  11. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  12. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  13. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  14. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  15. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  16. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  17. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  18. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Will FDA assign me a registration number? 1271.27... (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will...

  19. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Will FDA assign me a registration number? 1271.27... (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will...

  20. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Will FDA assign me a registration number? 1271.27... (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will...

  1. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...; (7) The address and location where the article of food is to be detained and the appropriate storage... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention order? 1.393 Section 1.393 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  2. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...; (7) The address and location where the article of food is to be detained and the appropriate storage... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What information must FDA include in the detention order? 1.393 Section 1.393 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  3. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

    Background Cincinnati Children’s Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration’s (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. Methods This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Results Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. Conclusions The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system. PMID:23617267

  4. FDA Recommends All Blood Donations Be Tested for Zika

    MedlinePlus

    ... FDA Recommends All Blood Donations Be Tested for Zika Updated guidance provides further protection for U.S. blood ... entire blood supply be routinely screened for the Zika virus. In February, the FDA recommended testing of ...

  5. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is... relationships among FDA and clinical trial staff, investigators, and institutional review boards...

  6. NIEHS/FDA CLARITY-BPA research program update.

    PubMed

    Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

    2015-12-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program.

  7. NIEHS/FDA CLARITY-BPA research program update.

    PubMed

    Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

    2015-12-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

  8. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule.

    PubMed

    1998-05-12

    The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives a significant adverse comment and withdraws this direct final rule.

  9. FDA publishes checklist of Y2K high-risk devices.

    PubMed

    1999-09-01

    Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.

  10. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    Cancer.gov

    The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

  11. Imaging as a tumor biomarker in oncology drug trials for lung cancer: the FDA perspective.

    PubMed

    Petrick, N; Brown, D G; Suleiman, O; Myers, K J

    2008-10-01

    The US Food and Drug Administration (FDA) is committed to working with the oncology community to expedite the drug evaluation process in view of the many promising new oncology drugs under laboratory development and the time and expense required for such new drugs to reach the patient population. One significant advance would be to enable quantitative imaging as a tumor biomarker. The FDA is working with the pharmaceutical industry, academia, and sister stakeholders in the government, primarily through collaborative educational and research efforts, to identify how imaging can serve this function. PMID:18716616

  12. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  13. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  14. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  15. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

    PubMed

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses. PMID:22400144

  16. Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights.

    PubMed

    Rose, Brenda

    2016-06-01

    As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 4 revised boxed warning from January through March 2016.

  17. The FDA's role in medical device clinical studies of human subjects

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  18. Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights.

    PubMed

    Rose, Brenda

    2016-06-01

    As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 4 revised boxed warning from January through March 2016. PMID:27354752

  19. The new NIH and FDA medical research policies: targeting gender, promoting justice.

    PubMed

    Baird, K L

    1999-06-01

    The National Institutes of Health (NIH) and Food and Drug Administration (FDA) have both recently revised their policies regarding the inclusion of women in clinical trials. Pressured by women's health activists and members of Congress, the NIH has vastly improved its policies; it now requires that women and minorities the included in clinical trials and that an analysis of gender and racial differences be performed. The FDA policy states that women and men should be included in clinical trials if both would receive the drug when marketed and that it expects a gender analysis to be performed. The FDA also lifted its 1977 ban on including women of childbearing potential in the early phases of drug studies. Analyzing these NIH and FDA policies according to a gender justice framework, I find that the NIH has moved significantly toward the institution of gender justice as it applies to medical research policies and that the FDA has taken only small steps toward this goal and lags behind the NIH.

  20. 76 FR 11789 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ...-796-5156, Daniel.Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of October 18, 2010 (75 FR 63838), the Agency announced that the proposed information collection had been...) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office...

  1. 77 FR 55845 - Science Board to the Food and Drug Administration: Request for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration: Request... Administration (FDA) is requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with...

  2. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    PubMed Central

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  3. FDA Approval Summary: Ramucirumab for Gastric Cancer.

    PubMed

    Casak, Sandra J; Fashoyin-Aje, Ibilola; Lemery, Steven J; Zhang, Lillian; Jin, Runyan; Li, Hongshan; Zhao, Liang; Zhao, Hong; Zhang, Hui; Chen, Huanyu; He, Kun; Dougherty, Michele; Novak, Rachel; Kennett, Sarah; Khasar, Sachia; Helms, Whitney; Keegan, Patricia; Pazdur, Richard

    2015-08-01

    The FDA approved ramucirumab (CYRAMZA; Eli Lilly and Company) for previously treated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma initially as monotherapy (April 21, 2014) and subsequently as combination therapy with paclitaxel (November 5, 2014). In the monotherapy trial, 355 patients in the indicated population were randomly allocated (2:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks. In the combination trial, 665 patients were randomly allocated (1:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks, in combination with paclitaxel, 80 mg/m(2) on days 1, 8, and 15 of 28-day cycles. Overall survival (OS) was increased in patients who received ramucirumab in both the monotherapy [HR, 0.78; 95% confidence interval (CI), 0.60-0.998; log rank P = 0.047] and combination trials (HR, 0.81; 95% CI, 0.68-0.96; P = 0.017). The most common adverse reactions were hypertension and diarrhea in the monotherapy trial and fatigue, neutropenia, diarrhea, and epistaxis in the combination trial. Because of concerns about the robustness of the monotherapy trial results, FDA approved the original application after receiving the results of the combination trial confirming the OS effect. Based on exploratory exposure-response analyses, there is residual uncertainty regarding the optimal dose of ramucirumab.

  4. 14 CFR 1214.1101 - Announcement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Announcement. 1214.1101 Section 1214.1101 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION SPACE FLIGHT NASA Astronaut Candidate... applicants may apply at any time. (c) Military personnel on active duty must apply through and be...

  5. 76 FR 18224 - Announcement of Award

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... Representation of Children in the Child Welfare System (QIC-ChildRep). CFDA Number: 93.652. Legislative Authority: Adoption Opportunities Program, section 203 of the Child Abuse Prevention and Treatment and Adoption Reform... HUMAN SERVICES Administration for Children and Families Announcement of Award AGENCY: Children's...

  6. 5 CFR 335.105 - Notice of job announcements to OPM.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Notice of job announcements to OPM. 335... PROMOTION AND INTERNAL PLACEMENT General Provisions § 335.105 Notice of job announcements to OPM. Under 5 U.S.C. 3330, agencies are required to report job announcements to OPM for vacancies for which...

  7. 5 CFR 335.105 - Notice of job announcements to OPM.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Notice of job announcements to OPM. 335... PROMOTION AND INTERNAL PLACEMENT General Provisions § 335.105 Notice of job announcements to OPM. Under 5 U.S.C. 3330, agencies are required to report job announcements to OPM for vacancies for which...

  8. 5 CFR 335.105 - Notice of job announcements to OPM.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Notice of job announcements to OPM. 335... PROMOTION AND INTERNAL PLACEMENT General Provisions § 335.105 Notice of job announcements to OPM. Under 5 U.S.C. 3330, agencies are required to report job announcements to OPM for vacancies for which...

  9. 5 CFR 335.105 - Notice of job announcements to OPM.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Notice of job announcements to OPM. 335... PROMOTION AND INTERNAL PLACEMENT General Provisions § 335.105 Notice of job announcements to OPM. Under 5 U.S.C. 3330, agencies are required to report job announcements to OPM for vacancies for which...

  10. 5 CFR 335.105 - Notice of job announcements to OPM.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Notice of job announcements to OPM. 335... PROMOTION AND INTERNAL PLACEMENT General Provisions § 335.105 Notice of job announcements to OPM. Under 5 U.S.C. 3330, agencies are required to report job announcements to OPM for vacancies for which...

  11. 77 FR 24553 - Announcement of National Small Business Week Video Contest Under the America Competes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-24

    ... ADMINISTRATION Announcement of National Small Business Week Video Contest Under the America Competes... of National Small Business Week 2012, the U.S. Small Business Administration (SBA) announces a video... Administration is looking for creative videos from small businesses that show how they have been assisted by...

  12. 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

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  13. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ..., 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the.... Background In the Federal Register of November 10, 2011 (76 FR 70150), FDA published a notice announcing the... mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is...

  14. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    .... 2201, Silver Spring, MD 20993-0002 (1-888-463-6332 or 301-796- 3400), or the Office of Communication....) In the Federal Register of May 24, 2011 (76 FR 30175), FDA announced the availability of the draft... represents FDA's current thinking on this topic. It does not create or confer any rights for or on any...

  15. Prescribing of FDA-approved and compounded hormone therapy differs by specialty

    PubMed Central

    Constantine, Ginger D.; Archer, David F.; Graham, Shelli; Bernick, Brian A.; Mirkin, Sebastian

    2016-01-01

    Abstract Objective: To determine the prescribing patterns of general practitioners (GPs), obstetrician/gynecologists (OB/GYNs), and wellness physicians (WPs) of menopausal hormone therapy (HT) for both compounded (CHT) and Food and Drug Administration (FDA)-approved products, using a survey of US physicians. Methods: Nine thousand one US physicians were invited to participate in a survey to report on their HT-prescribing patterns. Physicians were eligible if they prescribed HT for at least six patients per month. Results: The survey was completed by 440 eligible physicians (893 responded of 9,001 invited) including 171 GPs, 170 OB/GYNs, and 84 WPs. Physicians prescribed HT for 15% to 30% of their female patients, with WPs numerically most likely to prescribe HT. Menopausal symptoms were the leading reason for HT prescriptions among all specialties. WPs seemed more likely to prescribe HT for general/cardiovascular health (28%), and for shorter durations, than other specialties. WPs prescribed proportionally more compounded (vs FDA-approved) estrogens/progestogens than GPs or OB/GYNs, but OB/GYNs seemed to prescribe more compounded dehydroepiandrosterone and testosterone (prescribed alone) than did others. OB/GYNs seemed least likely to consider CHT being more safe or effective than FDA-approved HT. Symptom relief was the main determinant of efficacy for all specialties; WPs also used blood (61%) or saliva testing (25%) for dose adjustment. Conclusions: Although all physician specialties surveyed prescribed HT, differences in prescribing CHT versus FDA-approved formulations by medical specialty/practice seemed to exist. Of those surveyed, OB/GYNs and GPs prescribed proportionally more FDA-approved HT, whereas WPs, similarly, prescribed more CHT. More discussion is needed concerning physicians’ decisions to prescribe CHT versus FDA-approved formulations. PMID:27648594

  16. Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert

    PubMed Central

    Qato, Danya M.; Trivedi, Amal N.; Mor, Vincent; Dore, David D.

    2016-01-01

    Background Responsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly. Objective To compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups. Research Design A cohort study. Subjects Medicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims. Measures Outcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days’ supply for the last rosiglitazone claim during the study period (May 21, 2007–December 31, 2007) using multivariable proportional hazards models. Results More than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio = 0.90; 95% confidence interval, 0.86–0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio = 0.84; 95% confidence interval, 0.81–0.87). There were no observed differences across quintiles of area-level socioeconomic status. Conclusions White race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA’s safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations. PMID:26978569

  17. Biotechnology: the view from the FDA.

    PubMed

    Young, F E

    1986-01-01

    What is biotechnology? This is not a naive question. The Office of Technology Assessment has found differing definitions of biotechnology emanating from eight foreign countries and three international organizations. FDA's working definition of biotechnology is the application of biological systems and organisms to technical and industrial processes. This definition is necessarily broad. It takes in both the "old" and "new" science: the age-old techniques for making beer or yogurt as well as the most advanced uses of recombinant DNA technology. It takes in many applications, from production of enzymes for laundry detergents, to selective breeding of plants and animals, to genetic engineering of bacteria to clean up oil spills. As with any new technology, ethical issues are raised. But in the case of genetic engineering and cloning, many of the primordial fears of man concerning the power of science are awakened.

  18. US FDA oncology drug approvals in 2014.

    PubMed

    Wolford, Juliet E; Tewari, Krishnansu S

    2015-01-01

    Cancer is a close second to heart disease for cause of death in the USA, and could soon surpass heart disease as the population ages and the incidence of cancer continues to increase. While heart disease can be addressed through behavior modification and education (e.g., smoking cessation, dietary changes, exercises that promote cardiovascular fitness), pharmacology and improved surgical devices and methods, cancer ultimately requires improved and novel drug treatments to bring mortality rates down. In 2014, the US FDA approved 17 drugs and/or drug combinations in 12 disease sites for a total of 19 indications in melanoma, hematologic malignancies, gastrointestinal carcinoma, non-small-cell lung cancer, gynecologic malignancies and lymphoma/lymphoproliferative disorders. PMID:26039742

  19. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  20. Killing with kindness: why the FDA need not certify drugs used for execution safe and effective.

    PubMed

    Annas, G J

    1985-09-01

    In 1977, Texas and Oklahoma became the first states to legalize administration of the death penalty by lethal injection; by late 1985, 14 other states had followed suit. Opponents of the death penalty petitioned the Food and Drug Administration in 1980 to declare drugs specified for use in executions as "not approved," and to prevent their use for that purpose. When the FDA denied their request, the petitioners took legal action against the agency, eventually arguing their case before the U.S. Supreme Court, which ruled against them in Heckler v. Chaney (1985). Annas discusses the Court's action, which dealt only with the judicial reviewability under federal statute of the FDA's decision not to exercise its authority over the use of drugs in interstate commerce. He notes that, by dealing only with procedural issues, the Court avoided ruling on the death penalty itself.

  1. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  2. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  3. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  4. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... workshop regarding FDA's clinical trial requirements is designed to aid the clinical research professional... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  5. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  6. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  7. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  8. FDA Approves Test to Aid Post-PSA Biopsy Decisions | Division of Cancer Prevention

    Cancer.gov

    The Food and Drug Administration (FDA) has approved a test to help men with elevated prostate-specific antigen (PSA) test scores decide whether to have a biopsy to test for prostate cancer. The Access Hybritech p2PSA test is approved for use in men aged 50 or older who have a PSA test score between 4 and 10 ng/ml but who show no signs of cancer during a digital rectal exam. |

  9. Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

    PubMed

    Bradford, W David; Kleit, Andrew N

    2015-07-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. PMID:25059655

  10. FDA regulation of adult stem cell therapies as used in sports medicine.

    PubMed

    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.

  11. 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. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of...

  12. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5... ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The Division of Dockets Management public room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD...

  13. Recent legal developments and the authority of the Australian Therapeutic Goods Administration.

    PubMed

    Shirlow, Esme; Faunce, Thomas

    2009-05-01

    Recent legal developments have highlighted the need for greater support from the Federal Government for the authority of the Therapeutic Goods Administration (TGA) to ensure, by pre-approval assessments and post-approval regulation, the safety of listed medicines in Australia. One of these developments concerns the impact of ongoing civil litigation in Australian courts led by Pan Pharmaceuticals stakeholders to recover compensation from the government for the losses they incurred following the TGA's post-listing shut-down of that pharmaceutical manufacturing company in 2003. Another factor is the recently announced governmental policy to outsource to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) safety assessments of foreign drug manufacturers whose products will be used in Australia. PMID:19554858

  14. Recent legal developments and the authority of the Australian Therapeutic Goods Administration.

    PubMed

    Shirlow, Esme; Faunce, Thomas

    2009-05-01

    Recent legal developments have highlighted the need for greater support from the Federal Government for the authority of the Therapeutic Goods Administration (TGA) to ensure, by pre-approval assessments and post-approval regulation, the safety of listed medicines in Australia. One of these developments concerns the impact of ongoing civil litigation in Australian courts led by Pan Pharmaceuticals stakeholders to recover compensation from the government for the losses they incurred following the TGA's post-listing shut-down of that pharmaceutical manufacturing company in 2003. Another factor is the recently announced governmental policy to outsource to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) safety assessments of foreign drug manufacturers whose products will be used in Australia.

  15. 76 FR 78966 - Federal Aviation Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... Federal Aviation Administration Approval of Noise Compatibility Program for Kona International Airport at Keahole, Keahole, North Kona, HI AGENCY: Federal Aviation Administration, DOT. ACTION: Notice. SUMMARY: The Federal Aviation Administration (FAA) announces its findings on the noise compatibility...

  16. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    PubMed

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. PMID:26791369

  17. From bench to FDA to bedside: US regulatory trends for new stem cell therapies.

    PubMed

    Knoepfler, Paul S

    2015-03-01

    The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as "The Valley of Death". This moniker seems appropriate because it is at this point, and in particular in the work that ensues after Phase 1, clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here.

  18. From Bench to FDA to Bedside: US Regulatory Trends for New Stem Cell Therapies

    PubMed Central

    Knoepfler, Paul S.

    2015-01-01

    The phrase “bench to bedside” is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as “The Valley of Death”. This moniker seems appropriate because it is at this point and in particular in the work that ensues after Phase 1 clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here. PMID:25489841

  19. Use of surrogate outcomes in US FDA drug approvals, 2003–2012: a survey

    PubMed Central

    Yu, Tsung; Hsu, Yea-Jen; Fain, Kevin M; Boyd, Cynthia M; Holbrook, Janet T; Puhan, Milo A

    2015-01-01

    Objective To evaluate, across a spectrum of diseases, how often surrogate outcomes are used as a basis for drug approvals by the US Food and Drug Administration (FDA), and whether and how the rationale for using treatment effects on surrogates as predictors of treatment effects on patient-centred outcomes is discussed. Study design and setting We used the Drugs@FDA website to identify drug approvals produced from 2003 to 2012 by the FDA. We focused on four diseases (chronic obstructive pulmonary disease (COPD), type 1 or 2 diabetes, glaucoma and osteoporosis) for which surrogates are commonly used in trials. We reviewed the drug labels and medical reviews to provide empirical evidence on how surrogate outcomes are handled by the FDA. Results Of 1043 approvals screened, 58 (6%) were for the four diseases of interest. Most drugs for COPD (7/9, 78%), diabetes (26/26, 100%) and glaucoma (9/9, 100%) were approved based on surrogates while for osteoporosis, most drugs (10/14, 71%) were also approved for patient-centred outcomes (fractures). The rationale for using surrogates was discussed in 11 of the 43 (26%) drug approvals based on surrogates. In these drug approvals, we found drug approvals for diabetes are more likely than the other examined conditions to contain a discussion of trial evidence demonstrating that treatment effects on surrogate outcomes predict treatment effects on patient-centred outcomes. Conclusions Our results suggest that the FDA did not use a consistent approach to address surrogates in assessing the benefits and harms of drugs for COPD, type 1 or 2 diabetes, glaucoma and osteoporosis. For evaluating new drugs, patient-centred outcomes should be chosen whenever possible. If the use of surrogate outcomes is necessary, then a consistent approach is important to review the evidence for surrogacy and consider surrogate's usage in the treatment and population under study. PMID:26614616

  20. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document... 14, 2011 (76 FR 41506), FDA published a notice announcing the availability of the draft guidance... Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and...

  1. The US FDA and animal cloning: risk and regulatory approach.

    PubMed

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

  2. The FDA role in contact lens development and safety.

    PubMed

    Lippman, R E

    1990-01-01

    The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2189684

  3. FDA-Proposed Lab Practice Regulations Scored

    ERIC Educational Resources Information Center

    Murray, Chris

    1977-01-01

    Discusses the negative reactions to the Food & Drug Administration's proposed good laboratory practices for nonclinical laboratory practices. Industry representatives protest the inflexibility and excessive detail in the regulations. (MLH)

  4. FDA Asks Public: What Is 'Healthy Food'?

    MedlinePlus

    ... CDN, CPT, bariatric program director, Lenox Hill Hospital, New York City; U.S. Food and Drug Administration, news release, Sept. 27, 2016 HealthDay Copyright (c) 2016 HealthDay . All rights reserved. ...

  5. 78 FR 39734 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov . SUPPLEMENTARY INFORMATION:...

  6. 76 FR 53912 - FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... HUMAN SERVICES Food and Drug Administration FDA's Public Database of Products With Orphan-Drug... its public database of products that have received orphan-drug designation. The Orphan Drug Act... received orphan designation were published on our public database with non-informative code names....

  7. 78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... for Industry and FDA,'' dated July 2001. In the Federal Register of December 28, 2011 (76 FR 81511... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health Appeals Processes... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes...

  8. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro... entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic...

  9. 78 FR 23569 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  10. 77 FR 74021 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study: Disease Information in Branded Promotional Material AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  11. 78 FR 51211 - Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... Employment and Training Administration Announcement Regarding a Change in Eligibility for Unemployment... Emergency Unemployment Compensation 2008 (EUC08) Program AGENCY: Employment and Training Administration... 21, 2013, the three month average, seasonally adjusted total unemployment rate (TUR) in Louisiana...

  12. 76 FR 368 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling Regulations AGENCY: Food and Drug Administration... of information entitled ``Food Labeling Regulations'' has been approved by the Office of...

  13. 78 FR 22887 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... and Potential Harmful Tobacco Constituents AGENCY: Food and Drug Administration, HHS. ACTION:...

  14. The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted.

    PubMed

    Benet, L Z; Larregieu, C A

    2010-09-01

    Although US Food and Drug Administration (FDA)-approved Biopharmaceutics Classification System (BCS) class 1 drugs are designated as high-permeability drugs, in fact, the criterion utilized is high extent of absorption. This ambiguity should be eliminated, and the FDA criterion should explicitly be stated as > or =90% absorption based on absolute bioavailability or mass balance. Maintaining confidentiality regarding the drugs for which the FDA has approved BCS waivers of in vivo bioequivalence studies is not good public policy and should be reversed.

  15. ArrayTrack: a free FDA bioinformatics tool to support emerging biomedical research--an update.

    PubMed

    Xu, Joshua; Kelly, Reagan; Fang, Hong; Tong, Weida

    2010-08-01

    ArrayTrack is a Food and Drug Administration (FDA) bioinformatics tool that has been widely adopted by the research community for genomics studies. It provides an integrated environment for microarray data management, analysis and interpretation. Most of its functionality for statistical, pathway and gene ontology analysis can also be applied independently to data generated by other molecular technologies. ArrayTrack has been undergoing active development and enhancement since its inception in 2001. This review summarises its key functionalities, with emphasis on the most recent extensions in support of the evolving needs of FDA's research programmes. ArrayTrack has added capability to manage, analyse and interpret proteomics and metabolomics data after quantification of peptides and metabolites abundance, respectively. Annotation information about single nucleotide polymorphisms and quantitative trait loci has been integrated to support genetics-related studies. Other extensions have been added to manage and analyse genomics data related to bacterial food-borne pathogens.

  16. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    PubMed

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources. PMID:19042521

  17. Bodies of evidence: activists, patients, and the FDA regulation of Depo-Provera.

    PubMed

    Kline, Wendy

    2010-01-01

    In January 1983, the FDA held one of only two scientific "Public Boards of Inquiry" in the history of the administration to determine whether to approve Depo-Provera for use as a contraceptive in the United States. At the hearing, ideas about gender and power played a central role in negotiations between scientists, doctors, patients, and women's health activists. The nature of the Depo-Provera Public Board of Inquiry lends itself to analysis of the interaction between and among these groups, each of which had a vested interest in the outcome of the FDA decision. The stories and strategies emerging from the actors involved in the Public Board of Inquiry reveal the enormous complexity of regulating reproduction in the late twentieth century.

  18. 76 FR 67195 - Announcement of a Single-Source Grant Award to the National Association of Councils on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... Johnson, Administration on Developmental Disabilities, Administration for Children and Families, U.S... HUMAN SERVICES Administration for Children and Families Announcement of a Single-Source Grant Award to the National Association of Councils on Developmental Disabilities in Washington, DC...

  19. 5 CFR 362.202 - Announcement, nomination, and selection.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of the Presidential Management Fellows Program and know how to apply for nomination. The school must.... 362.202 Section 362.202 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PRESIDENTIAL MANAGEMENT FELLOWS PROGRAM Program Administration § 362.202 Announcement,...

  20. 75 FR 11610 - Notice Announcing Addresses for Service of Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... responsible for the jurisdiction in which the complaint has been filed. This notice replaces 70 FR 73320-01... From the Federal Register Online via the Government Publishing Office SOCIAL SECURITY ADMINISTRATION Notice Announcing Addresses for Service of Process AGENCY: Social Security Administration....

  1. The Facts on the FDA's New Tobacco Rule

    MedlinePlus

    ... agency authority to regulate the manufacturing, distribution, and marketing of tobacco products. Today, the rule does several ... law. And those manufacturers will have to receive marketing authorization from the FDA. The new rule also ...

  2. FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance

    MedlinePlus

    ... FDA is using cutting-edge technology called whole genome sequencing (WGS). A genome is an organism’s complete set of genes. In the 20 years since the first bacterial genome was completely sequenced, the science has advanced dramatically. ...

  3. FDA Renews Call to Reduce Salt in Processed Foods

    MedlinePlus

    ... consume more salt than recommended, the FDA pointed out. The problem is widespread in children and teens, too. Foods that are often high in sodium include pizza, sandwiches, deli meats, pasta dishes, snacks, salad dressings, soups and cheese. The ...

  4. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

    ... Updates What FDA Learned About Dark Chocolate and Milk Allergies Share Tweet Linkedin Pin it More sharing ... to top No Message Doesn’t Mean No Milk You shouldn’t assume that dark chocolate contains ...

  5. FDA OKs 1st Drug to Treat Duchenne Muscular Dystrophy

    MedlinePlus

    ... html FDA OKs 1st Drug to Treat Duchenne Muscular Dystrophy Exondys 51 seems to fill unmet need for ... the first drug for a rare form of muscular dystrophy. Exondys 51 (eteplirsen) was granted accelerated approval to ...

  6. FDA Facilitates Research on Earlier Stages of Alzheimer's Disease

    MedlinePlus

    ... Updates FDA Facilitates Research on Earlier Stages of Alzheimer's Disease Share Tweet Linkedin Pin it More sharing ... disease.” back to top New Paths for New Alzheimer’s Drugs FDA’s draft guidance aims to encourage research ...

  7. Starting Monday, FDA Banning E-Cigarette Sales to Minors

    MedlinePlus

    ... news/fullstory_160310.html Starting Monday, FDA Banning E-Cigarette Sales to Minors Agency also details other ... Aug. 8, 2016 (HealthDay News) -- The sale of e-cigarettes to minors will be banned starting Monday, ...

  8. Think Twice Before You Get That Tattoo: FDA

    MedlinePlus

    ... 159272.html Think Twice Before You Get That Tattoo: FDA Though popular, they carry infection risks and ... 8, 2016 WEDNESDAY, June 8, 2016 (HealthDay News) -- Tattoos are increasingly popular in the United States, but ...

  9. Ultraviolet light-an FDA approved technology

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Ultraviolet Light (254 nm) is a U.S. Food and Drug Administration approved nonthermal intervention technology that can be used for decontamination of food and food contact surfaces. Ultraviolet light is a green technology that leaves no chemical residues. Results from our laboratory indicate that ex...

  10. PREFACE: Fractional Differentiation and its Applications (FDA08) Fractional Differentiation and its Applications (FDA08)

    NASA Astrophysics Data System (ADS)

    Baleanu, Dumitru; Tenreiro Machado, J. A.

    2009-10-01

    The international workshop, Fractional Differentiation and its Applications (FDA08), held at Cankaya University, Ankara, Turkey on 5-7 November 2008, was the third in an ongoing series of conferences dedicated to exploring applications of fractional calculus in science, engineering, economics and finance. Fractional calculus, which deals with derivatives and integrals of any order, is now recognized as playing an important role in modeling multi-scale problems that span a wide range of time or length scales. Fractional calculus provides a natural link to the intermediate-order dynamics that often reflects the complexity of micro- and nanostructures through fractional-order differential equations. Unlike the more established techniques of mathematical physics, the methods of fractional differentiation are still under development; while it is true that the ideas of fractional calculus are as old as the classical integer-order differential operators, modern work is proceeding by both expanding the capabilities of this mathematical tool and by widening its range of applications. Hence, the interested reader will find papers here that focus on the underlying mathematics of fractional calculus, that extend fractional-order operators into new domains, and that apply well established methods to experimental and theoretical problems. The organizing committee invited presentations from experts representing the international community of scholars in fractional calculus and welcomed contributions from the growing number of researchers who are applying fractional differentiation to complex technical problems. The selection of papers in this topical issue of Physica Scripta reflects the success of the FDA08 workshop, with the emergence of a variety of novel areas of application. With these ideas in mind, the guest editors would like to honor the many distinguished scientists that have promoted the development of fractional calculus and, in particular, Professor George M

  11. FDA approval of expanded age indication for a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine.

    PubMed

    2011-09-23

    On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Originally, Boostrix was licensed in 2005 for persons aged 10 through 18 years, but in 2008, FDA approved an expanded age indication for Boostrix to include persons aged 19 through 64 years. FDA has now expanded the age indication to include persons aged 65 years and older. Boostrix is now licensed for use in persons aged 10 years and older as a single-dose booster vaccination. This notice summarizes the indications for use of Boostrix. Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously. Publication of revised Tdap recommendations within the next year is anticipated.

  12. Effect of the FDA on health care investments

    NASA Astrophysics Data System (ADS)

    Cleary, David J.

    1994-12-01

    The cost of securing FDA approval has long been an important consideration in funding projects involving new medical technologies, but the more stringent regulatory behavior of the FDA in the past few years has led to a discernable decrease in the funding of start-up medical device companies. An abundance of anecdotal evidence, supported with surveys of venture capital firms, investment groups and medical device corporations, indicates a serious shortage of funds available for the development of certain medical technologies.

  13. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with...

  14. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with...

  15. New aquaculture drugs under FDA review

    USGS Publications Warehouse

    Bowker, James D.; Gaikowski, Mark P.

    2012-01-01

    Only eight active pharmaceutical ingredients available in 18 drug products have been approved by the U.S. Food and Drug Administration for use in aquaculture. The approval process can be lengthy and expensive, but several new drugs and label claims are under review. Progress has been made on approvals for Halamid (chloramine-T), Aquaflor (florfenicol) and 35% PeroxAid (hydrogen peroxide) as therapeutic drugs. Data are also being generated for AQUI-S 20E, a fish sedative.

  16. Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

    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

    , 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.

  17. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    PubMed

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

  18. The role of data audits in detecting scientific misconduct. Results of the FDA program.

    PubMed

    Shapiro, M F; Charrow, R P

    1989-05-01

    To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly.

  19. Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor.

    PubMed

    Arns, Martijn; Loo, Sandra K; Sterman, M Barry; Heinrich, Hartmut; Kuntsi, Jonna; Asherson, Philip; Banaschewski, Tobias; Brandeis, Daniel

    2016-05-01

    Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD Assessment Aid (NEBA) Health test. The NEBA test relies upon an EEG-based measure, called the theta to beta ratio (TBR). Although this measure has yielded large differences between ADHD and non-ADHD groups in studies prior to 2009, recent studies and a meta-analysis could not replicate these findings. In this article, we have used the NEBA device as an exemplar for a discussion that distinguishes between FDA de novo marketing approval for a device and any claims that that device is empirically supported, scientifically validated with replicated findings. It is understood that the aims of each differ; however, for many, including the lay public as well as some mental health professionals, these terms may be confused and treated as though they are synonymous. With regard to the TBR measure, there is no reliable association or replication for its clinical usage in the ADHD diagnostic process. The recommendation for potential consumers of the NEBA Health test (as well as perhaps for other existing FDA-approved diagnostic tests) is caveat emptor (let the buyer beware!). PMID:27090383

  20. Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008

    PubMed Central

    Kornfield, Rachel; Watson, Sydeaka; Higashi, Ashley S.; Conti, Rena M.; Dusetzina, Stacie B.; Garfield, Craig F.; Dorsey, E. Ray; Huskamp, Haiden A.; Alexander, G. Caleb

    2014-01-01

    Objective This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. Methods Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. Results In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies—clonidine, guanfacine, and bupropion—was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. Conclusions FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit. PMID:23318985

  1. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... flavors or animal feed flavors) in accordance with laws and regulations administered by FDA. Under § 17... violate a ban or restriction of the U.S. Food and Drug Administration (FDA) pertaining to such products. If FDA bans or restricts the use of any ingredient in such a way that further manufacture of...

  2. FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine.

    PubMed

    Trumbo, Paula R

    2016-09-01

    The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, "This salt does not supply iodide, a necessary nutrient." If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

  3. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Cancer.gov

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  4. Statistical innovations in the medical device world sparked by the FDA.

    PubMed

    Campbell, Gregory; Yue, Lilly Q

    2016-01-01

    The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies. PMID:26372890

  5. Solyndra Loan Guarantee Announcement

    SciTech Connect

    Vice President Biden and Secretary Chu were joined by California Governor Arnold Schwarzenegger and Solyndra CEO Dr. Chris Grone

    2009-09-09

    Vice President Biden and Secretary Chu were joined by California Governor Arnold Schwarzenegger and Solyndra CEO Dr. Chris Grone to announce that the Department of Energy has finalized a $535 million loan guarantee for Solyndra, Inc., which manufactures innovative cylindrical solar photovoltaic panels that provide clean, renewable energy. The funding will finance construction of the first phase of the company's new manufacturing facility. Solyndra estimates the new plant will initially create 3,000 construction jobs, and lead to as many as 1,000 jobs once the facility opens.

  6. Solyndra Loan Guarantee Announcement

    ScienceCinema

    Vice President Biden and Secretary Chu were joined by California Governor Arnold Schwarzenegger and Solyndra CEO Dr. Chris Grone

    2016-07-12

    Vice President Biden and Secretary Chu were joined by California Governor Arnold Schwarzenegger and Solyndra CEO Dr. Chris Grone to announce that the Department of Energy has finalized a $535 million loan guarantee for Solyndra, Inc., which manufactures innovative cylindrical solar photovoltaic panels that provide clean, renewable energy. The funding will finance construction of the first phase of the company's new manufacturing facility. Solyndra estimates the new plant will initially create 3,000 construction jobs, and lead to as many as 1,000 jobs once the facility opens.

  7. 20 CFR 625.17 - Announcement of the beginning of a Disaster Assistance Period.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 3 2013-04-01 2013-04-01 false Announcement of the beginning of a Disaster Assistance Period. 625.17 Section 625.17 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR DISASTER UNEMPLOYMENT ASSISTANCE § 625.17 Announcement of the beginning of a...

  8. 77 FR 59986 - Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... Employment and Training Administration Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in New York in the Emergency Unemployment Compensation 2008 (EUC08) Program and the...: Notice. SUMMARY: Announcement regarding a change in eligibility for Unemployment Insurance (UI)...

  9. 20 CFR 625.17 - Announcement of the beginning of a Disaster Assistance Period.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Announcement of the beginning of a Disaster Assistance Period. 625.17 Section 625.17 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR DISASTER UNEMPLOYMENT ASSISTANCE § 625.17 Announcement of the beginning of a...

  10. 20 CFR 625.17 - Announcement of the beginning of a Disaster Assistance Period.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 3 2014-04-01 2014-04-01 false Announcement of the beginning of a Disaster Assistance Period. 625.17 Section 625.17 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR DISASTER UNEMPLOYMENT ASSISTANCE § 625.17 Announcement of the beginning of a...

  11. 20 CFR 625.17 - Announcement of the beginning of a Disaster Assistance Period.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Announcement of the beginning of a Disaster Assistance Period. 625.17 Section 625.17 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR DISASTER UNEMPLOYMENT ASSISTANCE § 625.17 Announcement of the beginning of a...

  12. 20 CFR 625.17 - Announcement of the beginning of a Disaster Assistance Period.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Announcement of the beginning of a Disaster Assistance Period. 625.17 Section 625.17 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR DISASTER UNEMPLOYMENT ASSISTANCE § 625.17 Announcement of the beginning of a...

  13. 75 FR 54655 - Announcement of the Career Videos for America's Job Seekers Challenge; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... Employment and Training Administration Announcement of the Career Videos for America's Job Seekers Challenge... Videos for America's Job Seekers Challenge. The dates for all phases of this Video Challenge have been... job seekers by: 1. Posting an announcement of the top ranking videos on key Web sites including:...

  14. 75 FR 33641 - Announcement of the Career Videos for America's Job Seekers Challenge; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-14

    ... Employment and Training Administration Announcement of the Career Videos for America's Job Seekers Challenge... the Career Videos for America's Job Seekers Challenge. The dates for all phases of this Video... community, and job seekers by: 1. Posting an announcement of the top ranking videos on key Web...

  15. 76 FR 368 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... of September 28, 2010 (75 FR 59722), the Agency announced that the proposed information collection... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Assessment for Submission to the Center for Food Safety and Applied Nutrition AGENCY: Food and...

  16. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration 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. SUMMARY: The Food and Drug Administration (FDA)...

  17. Update on antibacterial soaps: the FDA takes a second look at triclosans.

    PubMed

    Bergstrom, Kendra Gail

    2014-04-01

    In December of 2013 the Food and Drug Administration announced it would look further into the safety and efficacy of the biocide triclosan and requested further safety data as part of a new review with the Environmental Protection Agency. The use of triclosan has increased exponentially since its introduction in in 1972, to the point that 75% of commercial soap brands contain triclosan and 76% of a nationwide sample of adults and children excrete triclosan in the urine. This announcement raised an important dialog about the appropriate use of all over the counter biocides. Particular concerns include whether these biocides are more effective than regular soaps, whether they may create new drug resistant bacteria, and whether they may also act as hormone disruptors in humans or the environment.

  18. Update on antibacterial soaps: the FDA takes a second look at triclosans.

    PubMed

    Bergstrom, Kendra Gail

    2014-04-01

    In December of 2013 the Food and Drug Administration announced it would look further into the safety and efficacy of the biocide triclosan and requested further safety data as part of a new review with the Environmental Protection Agency. The use of triclosan has increased exponentially since its introduction in in 1972, to the point that 75% of commercial soap brands contain triclosan and 76% of a nationwide sample of adults and children excrete triclosan in the urine. This announcement raised an important dialog about the appropriate use of all over the counter biocides. Particular concerns include whether these biocides are more effective than regular soaps, whether they may create new drug resistant bacteria, and whether they may also act as hormone disruptors in humans or the environment. PMID:24719072

  19. FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space".

    PubMed

    Holden, Mark

    2015-01-01

    This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.

  20. 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. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health...

  1. 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 restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  2. 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 restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  3. 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 restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  4. 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 restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  5. 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 restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  6. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of... written notice recognizing exclusive approval once the marketing application for a designated orphan-drug... orphan-drug exclusive approval for the full 7-year term of exclusive approval. (b) When a...

  7. Seafood Contamination after the BP Gulf Oil Spill and Risks to Vulnerable Populations: A Critique of the FDA Risk Assessment

    PubMed Central

    Wong, Karen K.; Solomon, Gina M.

    2011-01-01

    Background: The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable levels [levels of concern (LOCs)] of PAH contaminants in Gulf Coast seafood. Objectives: We evaluated the degree to which the FDA’s risk criteria adequately protect vulnerable Gulf Coast populations from cancer risk associated with PAHs in seafood. Discussion: The FDA LOCs significantly underestimate risk from seafood contaminants among sensitive Gulf Coast populations by failing to a) account for the increased vulnerability of the developing fetus and child; b) use appropriate seafood consumption rates; c) include all relevant health end points; and d) incorporate health-protective estimates of exposure duration and acceptable risk. For benzo[a]pyrene and naphthalene, revised LOCs are between two and four orders of magnitude below the level set by the FDA. Comparison of measured levels of PAHs in Gulf seafood with the revised LOCs revealed that up to 53% of Gulf shrimp samples were above LOCs for pregnant women who are high-end seafood consumers. Conclusions: FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children. PMID:21990339

  8. The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?

    PubMed

    Brandt, Lawrence J

    2008-05-01

    The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision. PMID:18477347

  9. Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System.

    PubMed

    McInerney, Stephen

    2015-01-01

    Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, FDA published guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as "mobile medical applications." For the guidance to be effective, FDA must continue to work directly with all actors--including innovators, doctors, and patients--as the market for mobile health applications continues to develop. This Article argues that FDA should adopt a two-step plan--a pre-market notification program and a mobile medical application database--to aid in the successful implementation of its 2013 guidance. By doing so, FDA will ensure that this burgeoning market can reach its fullest potential.

  10. The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?

    PubMed

    Kerouac, James D

    2002-01-01

    This article discusses the Food and Drug Administration (FDA) authority to regulate home use diagnostics for genetic disorders based on the social effects of the devices in the premarket approval process (PMA). It begins with a discussion of the potential social impacts of home use genetic diagnostics, focusing particularly on the psychological effects of the devices. The article then discusses the FDA's past experience in regulating home use diagnostics for HIV and for drugs of abuse testing under its PMA authority. In approving PMA applications for home tests for HIV and drugs of abuse, the FDA has considered various social effects of the devices and tailored its approval to these considerations. However, the agency did not deny approval because of social considerations. The author argues that the FDA's past experience in approving PMA applications indicates both a willingness to consider social considerations in the PMA process and that the agency may deny a PMA application based on social considerations in appropriate circumstances. The author also argues that the FDA may deny application if the social impacts and other health risks of the device greatly outweigh the therapeutic benefits of the device. For example, in applications involving late onset genetic disorders for which no therapeutic options currently exist, the social risks of the device may be found to outweigh the benefits to health and therefore the FDA may deny a PMA application in these situations.

  11. 76 FR 39880 - Announcement of a Grant Award

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... HUMAN SERVICES Administration for Children and Families Announcement of a Grant Award AGENCY: Office of... combined Federal and non-Federal funds, promoting savings and enabling participants to acquire a lasting... three objectives: acquiring a first home; capitalizing a small business; or enrolling in...

  12. 10 CFR 903.11 - Advance announcement of rate adjustment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Advance announcement of rate adjustment. 903.11 Section 903.11 Energy DEPARTMENT OF ENERGY POWER AND TRANSMISSION RATES Procedures for Public Participation in Power and Transmission Rate Adjustments and Extensions for the Alaska, Southeastern, Southwestern, and Western Area Power Administrations §...

  13. 76 FR 41267 - Memorandum of Understanding Between the Food and Drug Administration and MEDSCAPE, LLC and WEBMD LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ...The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and MEDSCAPE, LLC AND WEBMD LLC. The purpose of the MOU is to complement FDA's capacity to educate and communicate with health care professionals. It will also promote the timely dissemination to health care professionals of accurate information on public health and emerging safety......

  14. 21 CFR 800.55 - Administrative detention.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Administrative detention. 800.55 Section 800.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should...

  15. 21 CFR 800.55 - Administrative detention.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Administrative detention. 800.55 Section 800.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should...

  16. 21 CFR 800.55 - Administrative detention.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Administrative detention. 800.55 Section 800.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should...

  17. 21 CFR 800.55 - Administrative detention.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Administrative detention. 800.55 Section 800.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should...

  18. 75 FR 36356 - Announcement of Changes to the Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... Commerce Human Resources Operations Center (DOCHROC), Office of Executive Resources Operations, 14th and... Commerce Human Resources Operations Center. BILLING CODE 3510-DS-P ... International Trade Administration Announcement of Changes to the Membership of the Performance Review...

  19. New Role for FDA-Approved Drugs in Combating Antibiotic-Resistant Bacteria.

    PubMed

    Andersson, Jourdan A; Fitts, Eric C; Kirtley, Michelle L; Ponnusamy, Duraisamy; Peniche, Alex G; Dann, Sara M; Motin, Vladimir L; Chauhan, Sadhana; Rosenzweig, Jason A; Sha, Jian; Chopra, Ashok K

    2016-06-01

    Antibiotic resistance in medically relevant bacterial pathogens, coupled with a paucity of novel antimicrobial discoveries, represents a pressing global crisis. Traditional drug discovery is an inefficient and costly process; however, systematic screening of Food and Drug Administration (FDA)-approved therapeutics for other indications in humans offers a rapid alternative approach. In this study, we screened a library of 780 FDA-approved drugs to identify molecules that rendered RAW 264.7 murine macrophages resistant to cytotoxicity induced by the highly virulent Yersinia pestis CO92 strain. Of these compounds, we identified 94 not classified as antibiotics as being effective at preventing Y. pestis-induced cytotoxicity. A total of 17 prioritized drugs, based on efficacy in in vitro screens, were chosen for further evaluation in a murine model of pneumonic plague to delineate if in vitro efficacy could be translated in vivo Three drugs, doxapram (DXP), amoxapine (AXPN), and trifluoperazine (TFP), increased animal survivability despite not exhibiting any direct bacteriostatic or bactericidal effect on Y. pestis and having no modulating effect on crucial Y. pestis virulence factors. These findings suggested that DXP, AXPN, and TFP may modulate host cell pathways necessary for disease pathogenesis. Finally, to further assess the broad applicability of drugs identified from in vitro screens, the therapeutic potential of TFP, the most efficacious drug in vivo, was evaluated in murine models of Salmonella enterica serovar Typhimurium and Clostridium difficile infections. In both models, TFP treatment resulted in increased survivability of infected animals. Taken together, these results demonstrate the broad applicability and potential use of nonantibiotic FDA-approved drugs to combat respiratory and gastrointestinal bacterial pathogens. PMID:27067323

  20. Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?

    PubMed Central

    Connolly, Gregory N; Alpert, Hillel R

    2014-01-01

    Background Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of “Lights” descriptors or similar terms on tobacco products that convey messages of reduced risk. Manufacturers eliminated terms explicitly stated and substituted colour name descriptors corresponding to the banned terms. This paper examines whether the tobacco industry complied with or circumvented the law and potential FDA regulatory actions. Methods Philip Morris retailer manuals, manufacturers' annual reports filed with the Massachusetts Department of Public Health, a national public opinion survey, and market-wide cigarette sales data were examined. Results Manufacturers substituted “Gold” for “Light” and “Silver” for “Ultra-light” in the names of Marlboro sub-brands, and “Blue”, “Gold”, and “Silver” for banned descriptors in sub-brand names. Percent filter ventilation levels, used to generate the smoke yield ranges associated with “Lights” categories, appear to have been reassigned to the new colour brand name descriptors. Following the ban, 92% of smokers reported they could easily identify their usual brands, and 68% correctly named the package colour associated with their usual brand, while sales for “Lights” cigarettes remained unchanged. Conclusions Tobacco manufacturers appear to have evaded a critical element of the FSPTCA, the ban on misleading descriptors that convey reduced health risk messages. The FPSTCA provides regulatory mechanisms, including banning these products as adulterated (Section 902). Manufacturers could then apply for pre-market approval as new products and produce evidence for FDA evaluation and determination whether or not sales of these products are in the public health interest. PMID:23485704

  1. Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

    ERIC Educational Resources Information Center

    Kaufman, Annette R.; Waters, Erika A.; Parascandola, Mark; Augustson, Erik M.; Bansal-Travers, Maansi; Hyland, Andrew; Cummings, K. Michael

    2011-01-01

    Objectives: To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. Methods: A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. Results: Smokers reporting that the FDA does not evaluate cigarettes for…

  2. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  3. An analysis of FDA-approved drugs for neurological disorders.

    PubMed

    Kinch, Michael S

    2015-09-01

    Neuroscience remains a great challenge and opportunity in terms of new drug discovery and development. An assessment of FDA-approved new molecular entities (NMEs) reveals a low steady rate of new FDA approvals, which is interrupted by two bursts in activity, first in the 1950s and then in the 1990s. These trends are reflected in the approvals for NMEs targeting multiple indications in this field, including seizure, Parkinson's disease and neuromuscular disorders. The majority of drugs target ion channels or G-protein-coupled receptors (GPCRs) but the mechanistic basis for many NMEs remains unclear or controversial. These trends could suggest future opportunities for success in a crucial field with considerable unmet needs.

  4. 76 FR 77302 - Federal Transit Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-12

    ... Federal Transit Administration FY 2011 Discretionary Sustainability Funding Opportunity; Transit... Sustainability Program Funds: Announcement of Project Selections. SUMMARY: The U.S. Department of Transportation... sustainability efforts and were announced in FTA's Notice of Funding Availability (NOFA) on June 24, 2011....

  5. QSAR Models at the US FDA/NCTR.

    PubMed

    Hong, Huixiao; Chen, Minjun; Ng, Hui Wen; Tong, Weida

    2016-01-01

    Quantitative structure-activity relationship (QSAR) has been used in the scientific research community for many decades and applied to drug discovery and development in the industry. QSAR technologies are advancing fast and attracting possible applications in regulatory science. To facilitate the development of reliable QSAR models, the FDA had invested a lot of efforts in constructing chemical databases with a variety of efficacy and safety endpoint data, as well as in the development of computational algorithms. In this chapter, we briefly describe some of the often used databases developed at the FDA such as EDKB (Endocrine Disruptor Knowledge Base), EADB (Estrogenic Activity Database), LTKB (Liver Toxicity Knowledge Base), and CERES (Chemical Evaluation and Risk Estimation System) and the technologies adopted by the agency such as Mold(2) program for calculation of a large and diverse set of molecular descriptors and decision forest algorithm for QSAR model development. We also summarize some QSAR models that have been developed for safety evaluation of the FDA-regulated products. PMID:27311476

  6. FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident

    MedlinePlus

    ... ia/importalert_621.html FDA may adjust this strategy based on additional information received from monitoring results in Japan. FDA may also further evaluate this strategy if the Government of Japan makes changes to ...

  7. 76 FR 70461 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-14

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Food and Drug Administration Form...

  8. 77 FR 38302 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Drug Administration Amendments Act of 2007'' to OMB for review and clearance under 44 U.S.C. 3507. An... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Implementation of the Food and Drug Administration...

  9. 78 FR 25456 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-01

    ... 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  10. 78 FR 25456 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-01

    ... review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  11. 77 FR 21565 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ... Office of Management and Budget Approval; Food and Drug Administration Recall Regulations AGENCY: Food... announcing that a collection of information entitled ``Food and Drug Administration Recall Regulations'' has... entitled ``Food and Drug Administration Recall Regulations'' to OMB for review and clearance under 44...

  12. Larval zebrafish model for FDA-approved drug repositioning for tobacco dependence treatment.

    PubMed

    Cousin, Margot A; Ebbert, Jon O; Wiinamaki, Amanda R; Urban, Mark D; Argue, David P; Ekker, Stephen C; Klee, Eric W

    2014-01-01

    Cigarette smoking remains the most preventable cause of death and excess health care costs in the United States, and is a leading cause of death among alcoholics. Long-term tobacco abstinence rates are low, and pharmacotherapeutic options are limited. Repositioning medications approved by the U.S. Food and Drug Administration (FDA) may efficiently provide clinicians with new treatment options. We developed a drug-repositioning paradigm using larval zebrafish locomotion and established predictive clinical validity using FDA-approved smoking cessation therapeutics. We evaluated 39 physician-vetted medications for nicotine-induced locomotor activation blockade. We further evaluated candidate medications for altered ethanol response, as well as in combination with varenicline for nicotine-response attenuation. Six medications specifically inhibited the nicotine response. Among this set, apomorphine and topiramate blocked both nicotine and ethanol responses. Both positively interact with varenicline in the Bliss Independence test, indicating potential synergistic interactions suggesting these are candidates for translation into Phase II clinical trials for smoking cessation.

  13. Proton-pump inhibitors in patients requiring antiplatelet therapy: new FDA labeling.

    PubMed

    Johnson, David A; Chilton, Robert; Liker, Harley R

    2014-05-01

    Proton-pump inhibitors (PPIs) are recommended for patients who require antiplatelet therapy and have a history of upper gastrointestinal bleeding. Proton-pump inhibitors should also be considered for patients receiving antiplatelet therapy who have other risk factors for gastrointestinal bleeding, including use of aspirin. Thus, evidence of pharmacokinetic and pharmacodynamic interactions between PPIs and consequent impaired effectiveness of the antiplatelet agent clopidogrel has caused concern. Here, we discuss comparative studies suggesting that the extent to which a PPI reduces exposure to the active metabolite of clopidogrel and attenuates its antithrombotic effect differs among PPIs. Although a clinically meaningful effect of the interaction between PPIs and clopidogrel on cardiovascular outcomes has not been established, these studies provided the basis for recent changes in US Food and Drug Administration (FDA) labeling for several PPIs and clopidogrel. New labeling suggests that PPI use among patients taking clopidogrel be limited to pantoprazole, rabeprazole, lansoprazole, or dexlansoprazole. Because comparative studies indicate that omeprazole and esomeprazole have a greater effect on the CYP2C19-mediated conversion of clopidogrel to its active metabolite and, consequently, clopidogrel's effect on platelet reactivity, FDA labeling recommends avoiding omeprazole and esomeprazole in patients taking clopidogrel. Even a 12-hour separation of dosing does not appear to prevent drug interactions between omeprazole and clopidogrel. PMID:24918808

  14. Smokers’ and Nonsmokers’ Beliefs About Harmful Tobacco Constituents: Implications for FDA Communication Efforts

    PubMed Central

    2014-01-01

    Introduction: Legislation requires the U.S. Food and Drug Administration (FDA) to release information to the public about harmful constituents in tobacco and tobacco smoke. To inform these efforts, we sought to better understand how smokers and nonsmokers think about tobacco constituents. Methods: In October 2012, 300U.S. adults aged 18–66 years completed a cross-sectional Internet survey. The questions focused on 20 harmful tobacco constituents that the FDA has prioritized for communicating with the public. Results: Most participants had heard of 7 tobacco constituents (ammonia, arsenic, benzene, cadmium, carbon monoxide, formaldehyde, and nicotine), but few participants had heard of the others (e.g., acrolein). Few participants correctly understood that many constituents were naturally present in tobacco. Substances that companies add to cigarette tobacco discouraged people from wanting to smoke more than substances that naturally occur in cigarette smoke (p < .001). Ammonia, arsenic, carbon monoxide, and formaldehyde being in cigarettes elicited the most discouragement from smoking. Constituents elicited greater discouragement from wanting to smoke if respondents were nonsmokers (β = −.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; β = .19, p < .05), believed constituents are added to tobacco (β = .14, p < .05), or were older (β = .16, p < .05). Conclusions: Our study found low awareness of most tobacco constituents, with greater concern elicited by additives. Efforts to communicate health risks of tobacco constituents should consider focusing on ones that elicited the most discouragement from smoking. PMID:24151139

  15. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers

    PubMed Central

    Do, Kathy T.

    2015-01-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

  16. Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal.

    PubMed

    Lerner, Herbert; Whang, Joyce; Nipper, Rebecca

    2013-03-01

    Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.

  17. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers.

    PubMed

    Do, Kathy T; Galván, Adriana

    2015-11-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers.

  18. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers.

    PubMed

    Do, Kathy T; Galván, Adriana

    2015-11-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

  19. News and Announcements

    NASA Astrophysics Data System (ADS)

    1999-06-01

    1999 EAS Awards The Eastern Analytical Symposium (EAS) announces the winners of their 1999 awards, which will be presented during their annual meeting, to be held November 14-19, 1999, at the Garden State Convention Center in Somerset, NJ. ACS Analytical Chemistry Division, Findeis Young Investigator Award

    • David Clemmer, Indiana University
    EAS Award for Achievements in Separation Science
    • Milton L. Lee, Brigham Young University
    EAS Award for Achievements in Near-Infrared Spectroscopy
    • Phil Williams, Grain Research Laboratory, Winnipeg, Canada
    EAS Award for Achievements in Magnetic Resonance
    • Frank A. L. Anet, University of California, Los Angeles (Emeritus)
    EAS Award for Outstanding Achievements in the Fields of Analytical Chemistry
    • Catherine Fenselau, University of Maryland at College Park
    Galactic Industries Award for Achievements in Chemometrics
    • Harald Martens, Norwegian University of Science and Technology
    Proposal Deadlines National Science Foundation Division of Undergraduate Education (DUE)
    • Course, Curriculum, and Laboratory Improvement (CCLI) June 7, 1999
    • NSF Collaboratives for Excellence in Teacher Preparation (CETP)
    • Preliminary proposals, Track 1 May 1, 1999
    • Formal proposals, Track 1 September 1, 1999
    • DUE online 1999 guidelines, NSF 99-53 available at http://www.nsf.gov/cgi-bin/getpub?nsf9953
    For further information about NSF DUE programs consult the DUE Web site, http://www.ehr.nsf.gov/EHR/DUE/start.htm. Program deadlines are at http://www.ehr.nsf.gov/EHR/DUE/programs/programs.htm . To contact the DUE Information Center, phone: 703/306-1666; email: undergrad@nsf.gov.

    The Camille and Henry Dreyfus Foundation, Inc.

    • Camille Dreyfus Teacher-Scholar Awards Program: November 16, 1998
    • Henry Dreyfus Teacher-Scholar Awards Program: July 1, 1999
    • New Faculty Awards Program: May 14, 1999
    • Faculty Start-up Grants

    • Perspective on Advancing FDA Regulatory Monitoring for Mycotoxins in Foods using Liquid Chromatography and Mass Spectrometry (Review).

      PubMed

      Zhang, Kai; Wong, Jon W; Krynitsky, Alexander J; Trucksess, Mary W

      2016-07-01

      The presence of mycotoxins (such as aflatoxins, deoxynivalenol, fumonisins, and patulin) is routinely monitored by the U.S. Food and Drug Administration (FDA) to ensure that their concentrations in food are below the levels requiring regulatory action or advisories. To improve the efficiency of mycotoxin analysis, the researchers at the FDA's Center for Food Safety and Applied Nutrition have been evaluating modern LC-MS technologies. Consequently, a variety of LC-tandem MS and LC-high-resolution MS methods have been developed, which simultaneously identify and quantitate multiple mycotoxins in foods and feeds. Although matrix effects (matrix-induced ion suppression or enhancement) associated with LC-MS-based mycotoxin analysis remain, this review discusses methods for managing these effects and proposes practical solutions for the future implementation of LC-MS-based multimycotoxin analysis. PMID:27330044

  1. Medical devices; invitation for offers to submit or to develop a performance standard for breathing frequency monitor (neonatal apnea monitor)--FDA. Proposed rule.

    PubMed

    1986-02-26

    The Food and Drug Administration (FDA) is issuing this notice to invite interested persons, including any Federal agency, to submit any existing standard as a proposed performance standard for the breathing frequency monitor intended for use on infants (also called the neonatal apnea monitor), or to submit an offer to develop such a proposed standard. If FDA does not receive any response to this notice, or receives a response but does not accept any existing standard or offer to develop a standard, the agency will proceed to develop a performance standard or take other appropriate action to facilitate the development of a performance standard for the device. PMID:10275306

  2. Is tobacco a drug? Administrative agencies as common law courts.

    PubMed

    Sunstein, C R

    1998-04-01

    Professor Cass Sunstein argues that the FDA has the authority to regulate tobacco products. He considers the text of the Federal Food, Drug, and Cosmetic Act, which supports the FDA assertion, and the context of its enactment, which argues against the FDA. He resolves the tension between text and context in favor of FDA jurisdiction by turning to the emerging role of administrative agencies. In modern government, he contends, administrative agencies have become America's common law courts, with the power to adapt statutory regimes to new facts and new values when the underlying statute is ambiguous. Professor Sunstein's Article, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit. PMID:10557544

  3. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic...

  4. Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.

    PubMed

    Parekh, A; Buckman-Garner, S; McCune, S; ONeill, R; Geanacopoulos, M; Amur, S; Clingman, C; Barratt, R; Rocca, M; Hills, I; Woodcock, J

    2015-03-01

    The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development.

  5. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data. PMID:25160375

  6. Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.

    PubMed

    Parekh, A; Buckman-Garner, S; McCune, S; ONeill, R; Geanacopoulos, M; Amur, S; Clingman, C; Barratt, R; Rocca, M; Hills, I; Woodcock, J

    2015-03-01

    The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development. PMID:25670629

  7. The FDA Perspective on Pre-Clinical Testing for High Intensity Focused Ultrasound Devices

    NASA Astrophysics Data System (ADS)

    Harris, Gerald R.

    2006-05-01

    In the U. S., the pre-market review of high intensity focused ultrasound (HIFU) devices is carried out under the authority of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act. Different regulatory mechanisms may apply depending on the complexity of the HIFU device and the indications for use, but in all cases pre-clinical testing is required. This testing typically includes ultrasound field characterization, thermal modeling and measurement, and may include demonstrating the accuracy of targeting and monitoring, if applicable. Because there are no guidance documents or standards for these tests at present, the U.S. Food and Drug Administration (FDA) welcomes working with interested parties to develop acceptable procedures that can be incorporated into the regulatory review process.

  8. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data.

  9. An analysis of FDA-approved drugs for infectious disease: antibacterial agents.

    PubMed

    Kinch, Michael S; Patridge, Eric; Plummer, Mark; Hoyer, Denton

    2014-09-01

    Drugs targeting infectious diseases have greatly improved public health. A study to evaluate all US Food and Drug Administration (FDA)-approved new molecular entities (NMEs) reveals that the number of new agents targeting infectious disease peaked during the 1990s and declined rapidly thereafter. Molecules targeting bacterial pathogens represent the most common component of anti-infectives followed by antivirals and antifungals. Focusing on antibacterial agents, an increase in new NMEs predominated from the 1960s through to the 1990s, dropping sharply thereafter. Obsolescence and resistance has eliminated one-third of these drugs. Consequently, the arsenal of antibiotics peaked in 2000 and is declining. Likewise, the number of organizations awarded at least one NME for a bacterial indication has declined to a level not seen in more than a half century. PMID:25043770

  10. 7 CFR 701.1 - Administration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the extent that the Deputy Administrator announces the eligibility of benefits for certain natural disasters, the areas in which such benefits will be available, the time period in which the disaster and...

  11. 7 CFR 701.1 - Administration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the extent that the Deputy Administrator announces the eligibility of benefits for certain natural disasters, the areas in which such benefits will be available, the time period in which the disaster and...

  12. 78 FR 55080 - Announcement of the Award of a Single-Source Program Expansion Supplement Grant to Massachusetts...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... HUMAN SERVICES Administration for Children and Families Office of Refugee Resettlement Announcement of the Award of a Single-Source Program Expansion Supplement Grant to Massachusetts Office for Refugees and Immigrants in Boston, MA AGENCY: Office of Refugee Resettlement, ACF, HHS. ACTION: Announcement...

  13. 20 CFR 633.202 - Announcement of State planning estimates and invitation to submit a grant application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Announcement of State planning estimates and... ADMINISTRATION, DEPARTMENT OF LABOR MIGRANT AND SEASONAL FARMWORKER PROGRAMS Grant Planning and Application Procedures § 633.202 Announcement of State planning estimates and invitation to submit a grant...

  14. 77 FR 37717 - Sunshine Act Meeting Notice; Matters To Be Deleted From the Agenda of a Previously Announced...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... ADMINISTRATION Sunshine Act Meeting Notice; Matters To Be Deleted From the Agenda of a Previously Announced Agency Meeting FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: June 18, 2012 (77 FR 36298). TIME AND... (All visitors must use Diagonal Road Entrance), Alexandria, VA 22314-3428. STATUS: Open. MATTERS TO...

  15. 75 FR 34488 - Sunshine Act; Notice of Matter To Be Deleted From the Agenda of a Previously Announced Open...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... ADMINISTRATION Sunshine Act; Notice of Matter To Be Deleted From the Agenda of a Previously Announced Open Meeting; and Notice of Matter To Be Added to the Agenda of a Previously Announced Closed Meeting TIME AND..., Alexandria, VA 22314-3428. STATUS: Open. Matter To Be Deleted 3. Proposed Rule--Part 741 of NCUA's Rules...

  16. 78 FR 45983 - Sunshine Act Meeting; Notice of Matter To Be Deleted from the Agenda of a Previously Announced...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... ADMINISTRATION Sunshine Act Meeting; Notice of Matter To Be Deleted from the Agenda of a Previously Announced Agency Meeting FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: July 22, 2013 (78 FR 43941). TIME AND... notice on July 22, 2013 (78 FR 43941) of the regular meeting of the NCUA Board scheduled for July...

  17. 76 FR 44048 - Sunshine Act Meeting; Notice of Matter To Be Deleted From the Agenda of a Previously Announced...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... ADMINISTRATION Sunshine Act Meeting; Notice of Matter To Be Deleted From the Agenda of a Previously Announced Agency Meeting Federal Register Citation of Previous Announcement: July 19, 2011 (76 FR 42736). TIME AND..., Alexandria, VA 22314-3428. STATUS: Open. Matter To Be Deleted 1. Final Rule--Parts 700, 701, 702, and 741...

  18. An analysis of FDA-approved drugs for oncology.

    PubMed

    Kinch, Michael S

    2014-12-01

    Cancer remains the second leading cause of death globally. The number of new medicines targeting cancer has grown impressively since the 1990s. On average, ten new drugs are introduced each year. Such growth has partly been achieved by emphasizing biologics and orphan indications, which account for one-quarter and one-half of new oncology drugs, respectively. The biotechnology industry likewise has become the primary driver of cancer drug development in terms of patents, preclinical and clinical research, although pharmaceutical companies are granted more FDA approvals. Many targeting strategies have been successful but recent trends suggest that kinase targets, although tractable, might be overemphasized.

  19. News and Announcements

    NASA Astrophysics Data System (ADS)

    1999-06-01

    1999 EAS Awards The Eastern Analytical Symposium (EAS) announces the winners of their 1999 awards, which will be presented during their annual meeting, to be held November 14-19, 1999, at the Garden State Convention Center in Somerset, NJ. ACS Analytical Chemistry Division, Findeis Young Investigator Award

    • David Clemmer, Indiana University
    EAS Award for Achievements in Separation Science
    • Milton L. Lee, Brigham Young University
    EAS Award for Achievements in Near-Infrared Spectroscopy
    • Phil Williams, Grain Research Laboratory, Winnipeg, Canada
    EAS Award for Achievements in Magnetic Resonance
    • Frank A. L. Anet, University of California, Los Angeles (Emeritus)
    EAS Award for Outstanding Achievements in the Fields of Analytical Chemistry
    • Catherine Fenselau, University of Maryland at College Park
    Galactic Industries Award for Achievements in Chemometrics
    • Harald Martens, Norwegian University of Science and Technology
    Proposal Deadlines National Science Foundation Division of Undergraduate Education (DUE)
    • Course, Curriculum, and Laboratory Improvement (CCLI) June 7, 1999
    • NSF Collaboratives for Excellence in Teacher Preparation (CETP)
    • Preliminary proposals, Track 1 May 1, 1999
    • Formal proposals, Track 1 September 1, 1999
    • DUE online 1999 guidelines, NSF 99-53 available at http://www.nsf.gov/cgi-bin/getpub?nsf9953
    For further information about NSF DUE programs consult the DUE Web site, http://www.ehr.nsf.gov/EHR/DUE/start.htm. Program deadlines are at http://www.ehr.nsf.gov/EHR/DUE/programs/programs.htm . To contact the DUE Information Center, phone: 703/306-1666; email: undergrad@nsf.gov.

    The Camille and Henry Dreyfus Foundation, Inc.

    • Camille Dreyfus Teacher-Scholar Awards Program: November 16, 1998
    • Henry Dreyfus Teacher-Scholar Awards Program: July 1, 1999
    • New Faculty Awards Program: May 14, 1999
    • Faculty Start-up Grants

    • Awareness of the role of science in the FDA regulatory submission process: a survey of the TERMIS-Americas membership.

      PubMed

      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

  1. Awareness of the role of science in the FDA regulatory submission process: a survey of the TERMIS-Americas membership.

    PubMed

    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

  2. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  3. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  4. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  5. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  6. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  7. Medical devices; performance standards for dental and mammographic X-ray devices; amendment--FDA. Proposed rule.

    PubMed

    1998-10-29

    The Food and Drug Administration (FDA) is proposing to exempt panoramic dental x-ray units from the requirement that they be manufactured with exposure timers which automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subjected to unnecessary radiation due to repeat radiographs. FDA also proposes five changes to align the performance standard with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (MQSA). First, the agency proposes to remove any reference to the use of equipment not specifically designed for mammography from the performance requirements for mammography equipment. Second, FDA proposes that the mammographic field alignment requirements restrict the irradiation beam to less than 2 percent of the source-image receptor distance (SID) beyond the image receptor edges. Third, it is proposed that the definition of an image receptor support device be amended to specify that it must provide a primary protective barrier for any orientation of the x-ray tube and image receptor support device assembly. Fourth, it is proposed that the useful beam must be confined to the dimensions of the primary barrier provided by the image receptor support device (except on the chest wall side). Fifth, it is proposed that exposures not be permitted without the primary barrier in place.

  8. Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

    PubMed

    O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah

    2016-08-01

    In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed. PMID:27414000

  9. Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

    PubMed

    O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah

    2016-08-01

    In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.

  10. 78 FR 6762 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... (60 FR 65096, December 18, 1995) and for juice (21 CFR part 120) in 2001 (66 FR 6138, January 19, 2001...-based rules for meat and poultry (9 CFR part 417) (61 FR 38806, July 25, 1996). In the Federal Register of January 16, 2013 (78 FR 3503 and 78 FR 3646), FDA announced the establishment of two dockets...

  11. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ...; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY... announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j) Reports... products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended...

  12. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... guidance of the same title was announced in the Federal Register on February 27, 2012 (77 FR 11553), and... availability of a guidance entitled ``FDA Oversight of PET Drug Products--Questions and Answers.'' This... Oversight of PET Drug Products--Questions and Answers.'' In 1997, Congress passed the Food and...

  13. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ...) application for the injector alone. For a combination product that includes the injector, the marketing...) or a PMA application for the injector alone. For a combination product that includes the injector... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance...

  14. Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.

    PubMed

    Sawant, Satin G; Fielden, Mark R; Black, Kurt A

    2014-10-01

    Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.

  15. FDA Escherichia coli Identification (FDA-ECID) Microarray: a Pangenome Molecular Toolbox for Serotyping, Virulence Profiling, Molecular Epidemiology, and Phylogeny

    PubMed Central

    Patel, Isha R.; Gangiredla, Jayanthi; Lacher, David W.; Mammel, Mark K.; Jackson, Scott A.; Lampel, Keith A.

    2016-01-01

    ABSTRACT Most Escherichia coli strains are nonpathogenic. However, for clinical diagnosis and food safety analysis, current identification methods for pathogenic E. coli either are time-consuming and/or provide limited information. Here, we utilized a custom DNA microarray with informative genetic features extracted from 368 sequence sets for rapid and high-throughput pathogen identification. The FDA Escherichia coli Identification (FDA-ECID) platform contains three sets of molecularly informative features that together stratify strain identification and relatedness. First, 53 known flagellin alleles, 103 alleles of wzx and wzy, and 5 alleles of wzm provide molecular serotyping utility. Second, 41,932 probe sets representing the pan-genome of E. coli provide strain-level gene content information. Third, approximately 125,000 single nucleotide polymorphisms (SNPs) of available whole-genome sequences (WGS) were distilled to 9,984 SNPs capable of recapitulating the E. coli phylogeny. We analyzed 103 diverse E. coli strains with available WGS data, including those associated with past foodborne illnesses, to determine robustness and accuracy. The array was able to accurately identify the molecular O and H serotypes, potentially correcting serological failures and providing better resolution for H-nontypeable/nonmotile phenotypes. In addition, molecular risk assessment was possible with key virulence marker identifications. Epidemiologically, each strain had a unique comparative genomic fingerprint that was extended to an additional 507 food and clinical isolates. Finally, a 99.7% phylogenetic concordance was established between microarray analysis and WGS using SNP-level data for advanced genome typing. Our study demonstrates FDA-ECID as a powerful tool for epidemiology and molecular risk assessment with the capacity to profile the global landscape and diversity of E. coli. IMPORTANCE This study describes a robust, state-of-the-art platform developed from available

  16. News and Announcements

    NASA Astrophysics Data System (ADS)

    1999-02-01

    News from Journal House Conceptual Questions and Challenge Problems Many readers are trying to modify the way they teach and in so doing are trying to write new types of questions and problems. The Journal has a new online resource, the JCE Internet Conceptual Questions and Challenge Problems Web site, http://jchemed.chem.wisc.edu/JCEWWW/Resources/CQandChP/index.html . The site is a source of questions and problems that can be used in teaching and assessing conceptual understanding and problem solving in chemistry. Here you can find a library of free-response and multiple-choice conceptual questions and challenge problems, tips for writing these questions and problems, and a discussion of types of concept questions. This site is intended to be a means of sharing conceptual questions and challenge problems among chemical educators. It will be as inclusive as possible, and to achieve this readers need to share their questions and alert the authors to references or Web sites. The screen captures shown below should provide a feeling for what you will find when you visit the site. The authors, William R. Robinson and Susan C. Nurrenbern, welcome additions to the library of conceptual questions or other comments or suggestions. Contact them by email, fax, or regular mail. William R. Robinson and Susan C. Nurrenbern, Department of Chemistry, Purdue University, West Lafayette, IN 47907-1393. Bill: phone: 765/494-5453; fax: 765/494-0239; email: wrrobin@purdue.edu. Sue: phone: 765/494-0823; fax: 765/494-0239; email: nurrenbe@purdue.edu. fax: 765/494-0239. 1998 Ford Foundation Fellowships The National Research Council has announced the recipients of the 1998 fellowships for minority scholars. Three categories of fellowships were awarded: 50 to beginning graduate students, 33 to students writing their dissertations, and 28 to recent Ph.D. recipients. There were about 1,000 applicants. For information about the next competition contact the Fellowship Office of the National

  17. News and Announcements

    NASA Astrophysics Data System (ADS)

    1999-02-01

    News from Journal House Conceptual Questions and Challenge Problems Many readers are trying to modify the way they teach and in so doing are trying to write new types of questions and problems. The Journal has a new online resource, the JCE Internet Conceptual Questions and Challenge Problems Web site, http://jchemed.chem.wisc.edu/JCEWWW/Resources/CQandChP/index.html . The site is a source of questions and problems that can be used in teaching and assessing conceptual understanding and problem solving in chemistry. Here you can find a library of free-response and multiple-choice conceptual questions and challenge problems, tips for writing these questions and problems, and a discussion of types of concept questions. This site is intended to be a means of sharing conceptual questions and challenge problems among chemical educators. It will be as inclusive as possible, and to achieve this readers need to share their questions and alert the authors to references or Web sites. The screen captures shown below should provide a feeling for what you will find when you visit the site. The authors, William R. Robinson and Susan C. Nurrenbern, welcome additions to the library of conceptual questions or other comments or suggestions. Contact them by email, fax, or regular mail. William R. Robinson and Susan C. Nurrenbern, Department of Chemistry, Purdue University, West Lafayette, IN 47907-1393. Bill: phone: 765/494-5453; fax: 765/494-0239; email: wrrobin@purdue.edu. Sue: phone: 765/494-0823; fax: 765/494-0239; email: nurrenbe@purdue.edu. fax: 765/494-0239. 1998 Ford Foundation Fellowships The National Research Council has announced the recipients of the 1998 fellowships for minority scholars. Three categories of fellowships were awarded: 50 to beginning graduate students, 33 to students writing their dissertations, and 28 to recent Ph.D. recipients. There were about 1,000 applicants. For information about the next competition contact the Fellowship Office of the National

  18. Considering the Future of Pharmaceutical Promotions in Social Media Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    PubMed

    Carpentier, Francesca Renee Dillman

    2016-01-01

    This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim's article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim's rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA's attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. PMID:27239874

  19. 75 FR 24707 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2010 (75 FR 2866),...

  20. 76 FR 2123 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ... Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50- ] 400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@FDA.HHS.GOV . SUPPLEMENTARY INFORMATION: In the Federal Register of October 18, 2010 (75 FR...

  1. 75 FR 24708 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2010 (75 FR 2871),...

  2. 75 FR 24708 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, e-mail: Daniel.Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2010 (75 FR...

  3. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

    PubMed Central

    Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

    2015-01-01

    Objective To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Design Cohort study. Setting FDA approved novel therapeutics between 1987 and 2014. Population Publicly available sources provided each drug’s year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA’s four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Main outcome measures Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. Results The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an

  4. Mining FDA drug labels using an unsupervised learning technique - topic modeling

    PubMed Central

    2011-01-01

    Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

  5. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in...

  6. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare Department... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in...

  7. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in...

  8. 78 FR 70248 - Medical Gas Regulation Review; Announcement of Public Meeting; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... the Federal Register of November 1, 2013 (78 FR 65588). The document announced a public meeting... Gross, Office of Executive Programs, Food and Drug Administration, 10903 New Hampshire Ave., Silver..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave.,...

  9. 75 FR 63489 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  10. 78 FR 37546 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-21

    ... Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices AGENCY... announcing that a collection of information entitled ``Administrative Detention and Banned Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act...

  11. 5 CFR 2413.6 - Notice of meetings; public announcement and publication.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Notice of meetings; public announcement and publication. 2413.6 Section 2413.6 Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY, GENERAL COUNSEL OF THE FEDERAL LABOR RELATIONS AUTHORITY AND FEDERAL SERVICE IMPASSES PANEL GENERAL PROVISIONS OPEN MEETINGS § 2413.6 Notice of...

  12. 75 FR 27824 - Announcement of the Career Videos for America's Job Seekers Challenge

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ... Employment and Training Administration Announcement of the Career Videos for America's Job Seekers Challenge... jobs. The ability to make such connections can be improved by increasing the workers' knowledge of the jobs that are in demand. The Employment and Training Administration (ETA) has identified 15...

  13. 76 FR 4918 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice AGENCY: Food and Drug Administration, HHS....

  14. Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database

    NASA Astrophysics Data System (ADS)

    Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.

    2012-02-01

    Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

  15. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

    PubMed

    Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

    2014-10-01

    Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

  16. Thalidomide, the FDA, and us -- what do you have? Underground compassionate use. Food and Drug Administration.

    PubMed

    1995-01-01

    It comes as no surprise to those in the underground that thalidomide, a TNF-inhibitor, is still defined by its teratogenicity, or ability to cause birth defects. In the late 1950s, thousands of babies were born with horrific birth defects after a company started marketing the drug as safe for morning sickness. Forty years later, after three double blind placebo-controlled studies, numerous case studies, and hundreds of anecdotal reports from doctors treating oral and throat ulcers, the drug is still in clinical trials, and not yet available to treat AIDS-relatetd wasting. Pilot studies of the drug show significant weight gain for patients. In addition, the drug is inexpensive and offers a specific mechanism of inhibiting an inflammatory chemical called TNF-alpha, the substance which presumably aggravates weight loss in people with AIDS. The Underground Thalidomide Compassionate Use Program will begin providing thalidomide as soon as they can secure a safe pharmaceutical supply.

  17. News and Announcements

    NASA Astrophysics Data System (ADS)

    1999-05-01

    like chemistry, and whether or not they are good at it. In Summary: Having served in many capacities, educational and governmental over my career, I have no illusions about the complexities involved in implementing change. Yet there is really no choice if we are to survive and thrive as a nation. We must shine a strong spotlight on education, with special and lasting emphasis on science and technology, and the real-world connections so apparent to us in chemistry and all the sciences. Lab Safety Training The Laboratory Safety Workshop announces laboratory safety training in six locations this summer. The 24-hour short courses are for secondary and college/university science educators. The dates and locations are:

    June 16-19: TBA, Minneapolis, MN June 23-26: Southwest Texas State Univ., San Marcos, TX July 7-10: University of Nevada-Reno, Reno, NV July 14-17: Northeastern University, Boston, MA August 3-6: College of Charleston, Charleston, SC August 16-19: TBA, Seattle, WA
    For further information contact Laboratory Safety Workshop, 192 Worcester Road, Natick, MA 01760-2552; phone: 508/647-1900; fax: 508/647-0062; email: lswpfm@aol.com. Proposal Deadlines National Science Foundation Division of Undergraduate Education (DUE)
    • Course, Curriculum, and Laboratory Improvement (CCLI) June 7, 1999
    • NSF Collaboratives for Excellence in Teacher Preparation (CETP) Preliminary proposals, Track 1 May 1, 1999 Formal proposals, Track 1 September 1, 1999
    • DUE online 1999 guidelines, NSF 99-53 available at http://www.nsf.gov/cgi-bin/getpub?nsf9953
    For further information about NSF DUE programs consult the DUE Web site at http://www.ehr.nsf.gov/EHR/DUE/start.htm. Program deadlines are at http://www.ehr.nsf.gov/EHR/DUE/programs/programs.htm . Contact the DUE Information Center at phone: 703/306-1666; email: undergrad@nsf.gov. The Camille and Henry Dreyfus Foundation, Inc.
    • Camille Dreyfus Teacher-Scholar Awards Program: November 16

    • FDA-approved small-molecule kinase inhibitors.

      PubMed

      Wu, Peng; Nielsen, Thomas E; Clausen, Mads H

      2015-07-01

      Kinases have emerged as one of the most intensively pursued targets in current pharmacological research, especially for cancer, due to their critical roles in cellular signaling. To date, the US FDA has approved 28 small-molecule kinase inhibitors, half of which were approved in the past 3 years. While the clinical data of these approved molecules are widely presented and structure-activity relationship (SAR) has been reported for individual molecules, an updated review that analyzes all approved molecules and summarizes current achievements and trends in the field has yet to be found. Here we present all approved small-molecule kinase inhibitors with an emphasis on binding mechanism and structural features, summarize current challenges, and discuss future directions in this field.

    • 76 FR 76980 - Notice of Listing of Members of the Food and Drug Administration's Senior Executive Service...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-12-09

      ... be named to serve on FDA's Senior Executive Performance Review Board or Panels, which oversee the evaluation of performance appraisals of FDA's Senior Executive Service (SES) members. The Civil Service... Administration's Senior Executive Service Performance Review Board AGENCY: Food and Drug Administration,...

    • FDA toxicity databases and real-time data entry

      SciTech Connect

      Arvidson, Kirk B.

      2008-11-15

      Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

  1. FDA toxicity databases and real-time data entry.

    PubMed

    Arvidson, Kirk B

    2008-11-15

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

  2. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ..., 2009, (74 FR 4685, January 26, 2009)). In response, the following June FDA launched its Transparency... Register (75 FR 76011, December 7, 2010) online at http://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative:...

  3. News and Announcements

    NASA Astrophysics Data System (ADS)

    1999-04-01

    ://www.uoi.gr/conf_sem/ecrice5. Symposium on Natural Products: Chemistry and Bioactivity Hauser and the Department of Chemistry and Biochemistry at the University of Colorado at Boulder are offering a three-day symposium on natural products which include pharmaceuticals, nutraceuticals, and consumer products, to be held May 19-21, 1999. For further information or to make arrangements to attend, contact University of Colorado at Boulder, Attn: Rosemary Trujillo, Campus Box 215, Boulder, CO 80309-0215; email: rosemary.trujillo@colorado.edu; fax: 303/492-0439. Workshops for Small-Scale Chemistry The Center for Science, Mathematics and Technology Education at Colorado State University announces two workshop programs for summer 1999. Interested community college faculty are invited to apply for the Small-Scale Chemistry for Pollution Prevention Summer Institute, June 7-18, 1999. The Institute features hands-on training in small-scale chemistry laboratory techniques. Travel to Fort Collins, CO, lodging, per diem, and classroom/laboratory materials are funded for selected participants with a grant from the U.S. Environmental Protection Agency in collaboration with the Partnership for Environmental Technology Education (PETE). For more information contact Barry Carroll by email: barry_carroll@csmate.colostate.edu; phone: 970/491-1700, or access http://www.csmate.colostate.edu/Programs/PETE_Page.html. Interested high school teachers are invited to apply for two one-week workshops in Small-Scale Chemistry Laboratory for the Regular Chemistry Course (June 21-25, 1999) and Small-Scale Chemistry Laboratory for Advanced Placement Chemistry (June 28-July 2, 1999). The workshops feature hands-on training in small-scale chemistry laboratory techniques. Classroom/laboratory materials, books, and two graduate credits are included in the $395 fee for each course. For more information contact Courtney Butler by email: courtney@ csmate.colostate.edu, phone: 970/491-1700, or access http

  4. A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions

    PubMed Central

    Briesacher, Becky A.; Soumerai, Stephen B.; Zhang, Fang; Toh, Sengwee; Andrade, Susan E.; Wagner, Joann L.; Shoaibi, Azadeh; Gurwitz, Jerry H.

    2013-01-01

    Purpose To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions, and identify best practices for future evaluations. Methods We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity, and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. Results We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. Conclusions Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies. PMID:23847020

  5. Key Obama officials leave administration

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2013-01-01

    Secretary of the Interior Ken Salazar is one of the latest members of the Obama administration to announce that he is leaving his position near the start of President Obama's second term in office. Salazar, who has served as interior secretary since January 2009, intends to leave the department by the end of March, the department noted on 16 January. Salazar joins a number of other key officials who are planning to leave the administration. They include Environmental Protection Agency administrator Lisa Jackson, National Oceanic and Atmospheric Administration administrator Jane Lubchenco, and U.S. Geological Survey director Marcia McNutt.

  6. Radiation recommendation series: administratively required dental radiographs

    SciTech Connect

    Not Available

    1981-09-01

    Administrative requirements for radiographs are found in many segments of the United States health care system. This document presents an FDA radiation recommendation on administratively required dental x-ray examinations. In general, such examinations are not requested to further the patient's dental health, but rather as a means of monitoring claims. However, the administrative use of radiographs that have been taken in the normal course of patient care is usually appropriate, as long as the patient's right to privacy is respected.

  7. PUBLISHER'S ANNOUNCEMENT: Refereeing standards

    NASA Astrophysics Data System (ADS)

    Bender, C.; Scriven, N.

    2004-08-01

    On 1 January 2004 I will be assuming the position of Editor-in-Chief of Journal of Physics A: Mathematical and General (J. Phys. A). I am flattered at the confidence expressed in my ability to carry out this challenging job and I will try hard to justify this confidence. The previous Editor-in-Chief, Ed Corrigan, has worked tirelessly for the last five years and has done an excellent job for the journal. Everyone at the journal is profoundly grateful for his leadership and for his achievements. Before accepting the position of Editor-in-Chief, I visited the office of J. Phys. A to examine the organization and to assess its strengths and weaknesses. This office is located at the Institute of Physics Publishing (IOPP) headquarters in Bristol. J. Phys. A has been expanding rapidly and now publishes at the rate of nearly 1000 articles (or about 14,000 pages) per year. The entire operation of the journal is conducted in a very small space---about 15 square metres! Working in this space are six highly intelligent, talented, hard working, and dedicated people: Neil Scriven, Publisher; Mike Williams, Publishing Editor; Rose Gray and Sarah Nadin, Publishing Administrators; Laura Smith and Steve Richards, Production Editors. In this small space every day about eight submitted manuscripts are downloaded from the computer or received in the post. These papers are then processed and catalogued, referees are selected, and the papers are sent out for evaluation. In this small space the referees' reports are received, publication decisions are made, and accepted articles are then published quickly by IOPP. The whole operation is amazingly efficient. Indeed, one of the great strengths of J. Phys. A is the speed at which papers are processed. The average time between the receipt of a manuscript and an editorial decision is under sixty days. (Many distinguished journals take three to five times this amount of time.) This speed of publication is an extremely strong enticement for

  8. 77 FR 65196 - Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the Regents of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ...) of the Child Abuse Prevention and Treatment and Adoption Reform Act (CAPTA) of 1978, (Pub. L. 95-266... HUMAN SERVICES Administration for Children and Families Announcement of the Award of a Single-Source..., MI AGENCY: Children's Bureau, Administration on Children, Youth and Families, Administration...

  9. 76 FR 67195 - Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the University...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... HUMAN SERVICES Administration for Children and Families Announcement of the Award of a Single-Source... Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded a..., yet practical, ethical, and affordable research design for this evaluation. The data will...

  10. Teratological evaluation of FD&C Red no. 2 -a collaborative government-industry study. II. FDA's study.

    PubMed

    Collins, T F; Black, T N; Ruggles, D I; Gray, G C

    1976-05-01

    Because of recent studies indicating possible embryolethality and teratogenicity of FD&C Red No. 2, and ad hoc committee was convened by the Food and Drug Administration to consider these questions. The committee suggested a collaborative study by three laboratories [Food and Drug Administration (FDA), Industrial Bio-Test Laboratories (IBT), and National Center for Toxicological Research (NCTR)] in which Red No. 2 was given at 200 mg/kg body weight, by gavage during days 0-19, 6-15, or 7-9 of gestation. FD&C Red No. 2 was also given at the same dose level via water bottle. Appropriate controls were utilized. FDA used Osborne-Mendel strain rats, IBT used Charles River, and NCTR used both strains. No significant increases in skeletal or visceral abnormalities were seen. No significant increase in resorptions was seen in the Osborne-Mendel strain, but the Charles River strain at IBT showed a significant increase in litters with two or more resorptions after dams had been given 200 mg/kg at 0-19 days of gestation. The NCTR study on the Charles River strain also showed an increase in the same parameter for the same dose level and in addition showed a significant increase in the percentage of resorptions per litter. It was concluded that because of the inherent variation and the absence of an increase in abnormalities or other indications of embryotoxicity, there is reason to doubt that this effect is either biologically significant or reproducible.

  11. Preparation of spread oils meeting U.S. Food and Drug Administration Labeling requirements for trans fatty acids via pressure-controlled hydrogenation.

    PubMed

    Eller, Fred J; List, Gary R; Teel, Jeffrey A; Steidley, Kevin R; Adlof, Richard O

    2005-07-27

    On July 11, 2003, the U.S. Food and Drug Administration (FDA) announced final regulations for trans fatty acid (TFA) labeling. By January 1, 2006, the TFA content of foods must be labeled as a separate line on the Nutrition Facts label. Products containing <0.5 g of TFA/14 g serving may be declared as zero. This paper describes technologies allowing compliance with TFA labeling requirements. Soybean oil was hydrogenated in a 2-L vessel at temperatures ranging from 120 to 170 degrees C at a hydrogen pressure of 200 psi. A commercial nickel-supported catalyst (25% Ni) was used at 0.02% Ni by weight of oil. The hydrogenated oils were characterized for fatty acid composition, solid fat content, and melting point. Compared to commercially processed soybean oil basestocks that typically contain approximately 40% TFA, those obtained at lower temperatures and higher pressures contain >56% less TFA. Basestocks prepared in the laboratory when blended with liquid soybean oil will yield spread oils meeting FDA labeling requirements for zero TFA, that is, <0.5 g of TFA/serving.

  12. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010.

    PubMed

    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.

  13. US Food and Drug Administration Web Site: A Primer for Pharmacists.

    PubMed

    Leonard, James; Baker, Danial E

    2015-11-01

    The US Food and Drug Administration (FDA) Web site includes a vast amount of information, but it can be difficult to navigate. Despite frequently asked question (FAQ)-type pages within the Web site, it may not be easy for first-time users to find drug information. This article presents some examples of common questions, provides the locations of the answers on the FDA Web site, and gives a brief description of some of the many resources the FDA provides for health care professionals. Additionally, a newer project being undertaken by the FDA, Snapshot, is introduced. PMID:27621506

  14. 75 FR 73951 - Amendments to General Regulations of the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... procedures for issuing a direct final rule? In the Federal Register of November 21, 1997 (62 FR 62466), FDA... document entitled ``Guidance for FDA and Industry: Direct Final Rule Procedures'' (62 FR 62466). This... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 RIN 0910-AG55 Amendments...

  15. 76 FR 31345 - Cooperative Arrangement Between the United States Food and Drug Administration and the Inter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ...The Food and Drug Administration (FDA) is providing notice of a cooperative arrangement between FDA and the Inter-American Institute for Cooperation in Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to facilitate the exchange of information and the development of projects of mutual...

  16. 77 FR 50114 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance... this document. Table 1--Previous Publication of Standard Recognition Lists February 25, 1998 (63 FR 9561). October 16, 1998 (63 FR 55617). July 12, 1999 (64 FR 37546). November 15, 2000 (65 FR...

  17. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... FR 50483), FDA announced the availability of the draft guidance. Interested persons were invited to...; Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de... entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket...

  18. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ...-796-2533. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of May 30, 2008 (73 FR... class II (special controls). Also, in the Federal Register of May 30, 2008 (73 FR 31128), FDA announced...''; (4) rewording the ``Automatic Exposure Control Performance'' section to ask for data based on...

  19. 78 FR 2998 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... Staphylococcus aureus, Hard Surface Carrier Test Method. 14-215 AOAC 6.2.05:2006 Official Method 991.49 Testing... of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled... document. Table 1--Previous Publications of Standard Recognition Lists February 25, 1998 (63 FR...

  20. 75 FR 24711 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced... Recognition Lists February 25, 1998 (63 FR 9561) May 27, 2005 (70 FR 30756) October 16, 1998 (63 FR 55617) November 8, 2005 (70 FR 67713) July 12, 1999 (64 FR 37546) March 31, 2006 (71 FR 16313) November 15,...