Science.gov

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.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  3. FDA reform signed into law. Food and Drug Administration.

    PubMed

    James, J S

    1997-12-05

    The laws under which the Food and Drug Administration (FDA) operates have been changed by bipartisan Congressional efforts. The FDA Modernization Act of 1997, signed into law on November 21, 1997 modifies the mission of the FDA to include a goal of speeding research, innovation and access to care. The legislation allows fast track review for the most important drugs. It also allows drug companies to promote off label use of already-approved pharmaceuticals for other purposes. The controversial issue allows drug companies to provide physicians with documentation on the effectiveness of their drugs in treating other conditions. The industry supports the change since the revenue growth for off label use of drugs is especially important for smaller biotechnical companies, while consumer groups fear that it is a loophole for selling unproven drugs. The bill also renews the Prescription Drug User Fee Act (PDUFA), regulating the current practice of compounding, and monitoring medical devices and health care claims for foods.

  4. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Commercially... Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  5. 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.

  6. 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).

  7. 76 FR 11789 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Testing Communications on Medical Devices and Radiation... Administration (FDA) is announcing that a collection of information entitled ``Testing Communications on...

  8. 77 FR 42500 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Examination of Online Direct-to- Consumer Prescription Drug... Administration (FDA) is announcing that a collection of information entitled ``Examination of Online...

  9. 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.

  10. Announcements

    NASA Astrophysics Data System (ADS)

    1997-04-01

    Meeting on Biochemical Education ChemCom Workshops '97 12th ICCCRE Westinghouse Science Talent Search Eastern Analytical Symposium Conference on Coordination Chemistry Announcements from American Oil Chemists' Society

  11. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  14. 76 FR 56770 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global...: The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing...

  15. 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

    ...; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled... CDRH and FDA. DATES: Submit either electronic or written comments on this guidance at any time....

  16. 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.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance.... This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight...

  17. 76 FR 62418 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Requirements; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register...

  18. 78 FR 48689 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... Office of Management and Budget Approval; Prescription Drug User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug User Fee Cover Sheet; Form FDA...

  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

    ... Office of Management and Budget Approval; Medical Device User Fee Cover Sheet--Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover Sheet--Form FDA...

  20. 78 FR 46954 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... Office of Management and Budget Approval; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover Sheet, Form FDA...

  1. Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies.

    PubMed

    Eaglstein, William H; Kirsner, Robert S; Robson, Martin C

    2012-01-01

    The rising costs of caring for chronic cutaneous ulcers (CCUs) and recent appreciation of the mortality of CCUs have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCUs have been approved by the Food and Drug Administration (FDA) in over a decade, in part due to an inability to reach the FDA accepted end point of "complete wound closure." The frequent failure to reach the complete closure end point brings forward the question of the relevance of other healing end points such as improved quality of life, or partial healing. Because CCUs carry a prognosis and mortality rate worse than many cancers, it is reasonable to compare the FDA trial end points for cancer drug approval with those for CCUs. And the difference is quite striking. While there is only one end point for CCUs, there are five surrogate and three direct end points for cancers. In contrast to cancer, surrogate end points and partial healing are not acceptable for therapies aimed at CCUs. For example, making tumors smaller is an acceptable end point, but making CCUs smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCUs. As CCUs carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCUs is highly warranted.

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  3. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    PubMed

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  4. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance.

    PubMed

    Ball, R; Robb, M; Anderson, S A; Dal Pan, G

    2016-03-01

    In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products.

  5. 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.

  6. Rationale, Procedures, and Response Rates for the 2015 Administration of NCI's Health Information National Trends Survey: HINTS-FDA 2015.

    PubMed

    Blake, Kelly D; Portnoy, David B; Kaufman, Annette R; Lin, Chung-Tung Jordan; Lo, Serena C; Backlund, Eric; Cantor, David; Hicks, Lloyd; Lin, Amy; Caporaso, Andrew; Davis, Terisa; Moser, Richard P; Hesse, Bradford W

    2016-12-01

    The National Cancer Institute (NCI) developed the Health Information National Trends Survey (HINTS) to monitor population trends in cancer communication practices, information preferences, health risk behaviors, attitudes, and cancer knowledge. The U.S. Food and Drug Administration (FDA) recognized HINTS as a unique data resource for informing its health communication endeavors and partnered with NCI to field HINTS-FDA 2015. HINTS-FDA 2015 was a self-administered paper instrument sent by mail May 29 to September 8, 2015, using a random probability-based sample of U.S. postal addresses stratified by county-level smoking rates, with an oversampling of high and medium-high smoking strata to increase the yield of current smokers responding to the survey. The response rate for HINTS-FDA 2015 was 33% (N = 3,738). The yield of current smokers (n = 495) was lower than expected, but the sampling strategy achieved the goal of obtaining more former smokers (n = 1,132). Public-use HINTS-FDA 2015 data and supporting documentation have been available for download and secondary data analyses since June 2016 at http://hints.cancer.gov . NCI and FDA encourage the use of HINTS-FDA for health communication research and practice related to tobacco-related communications, public knowledge, and behaviors as well as beliefs and actions related to medical products and dietary supplements.

  7. Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).

    PubMed

    Weaver, Joyce; Grenade, Lois La; Kwon, Hyon; Avigan, Mark

    2009-01-01

    Marketed pharmaceuticals are evaluated for safety by the US Food and Drug Administration (FDA) throughout the life cycle of the products. The FDA uses data from controlled clinical trials, from postmarketing case reports reported to the FDA's Adverse Event Reporting System, from epidemiological studies, and from registries to evaluate the safety of approved products. For some products, including some products used in dermatologic medicine, risks become apparent during the postmarketing period that require additional measures beyond product labeling and routine pharmacovigilance. The FDA continues to seek additional tools to assess risk, including pharmacogenomic biomarkers for adverse drug reactions and the use of large medical record and epidemiological databases for the systematic detection and characterization of drug-associated safety outcomes.

  8. 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....

  9. 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....

  10. 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....

  11. 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....

  12. 76 FR 40734 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ...-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement...

  13. 7 CFR 1032.45 - Market administrator's reports and announcements concerning classification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 9 2010-01-01 2009-01-01 true Market administrator's reports and announcements concerning classification. 1032.45 Section 1032.45 Agriculture Regulations of the Department of Agriculture... MILK IN THE CENTRAL MARKETING AREA Order Regulating Handling Classification of Milk § 1032.45...

  14. 7 CFR 1032.45 - Market administrator's reports and announcements concerning classification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 9 2012-01-01 2012-01-01 false Market administrator's reports and announcements concerning classification. 1032.45 Section 1032.45 Agriculture Regulations of the Department of Agriculture... MILK IN THE CENTRAL MARKETING AREA Order Regulating Handling Classification of Milk § 1032.45...

  15. 7 CFR 1032.45 - Market administrator's reports and announcements concerning classification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 9 2011-01-01 2011-01-01 false Market administrator's reports and announcements concerning classification. 1032.45 Section 1032.45 Agriculture Regulations of the Department of Agriculture... MILK IN THE CENTRAL MARKETING AREA Order Regulating Handling Classification of Milk § 1032.45...

  16. 7 CFR 1032.45 - Market administrator's reports and announcements concerning classification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 9 2014-01-01 2013-01-01 true Market administrator's reports and announcements concerning classification. 1032.45 Section 1032.45 Agriculture Regulations of the Department of Agriculture... MILK IN THE CENTRAL MARKETING AREA Order Regulating Handling Classification of Milk § 1032.45...

  17. 7 CFR 1032.45 - Market administrator's reports and announcements concerning classification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 9 2013-01-01 2013-01-01 false Market administrator's reports and announcements concerning classification. 1032.45 Section 1032.45 Agriculture Regulations of the Department of Agriculture... MILK IN THE CENTRAL MARKETING AREA Order Regulating Handling Classification of Milk § 1032.45...

  18. FACT SHEET: Administration Takes Steps Forward on Climate Action Plan by Announcing Actions to Cut Methane Emissions

    EPA Pesticide Factsheets

    The Obama Administration is committed to taking responsible steps to address climate change and help ensure a cleaner, more stable environment for future generations. As part of that effort, today, the Administration is announcing a new goal to cut methane

  19. 78 FR 23569 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... Office of Management and Budget Approval; Electronic Submission of Medical Device Registration and... Administration (FDA) is announcing that a collection of information entitled ``Electronic Submission of Medical... submitted a proposed collection of information entitled ``Electronic Submission of Medical...

  20. 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...

  1. 77 FR 74021 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study: Disease Information in Branded Promotional Material'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  2. 76 FR 56200 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... Office of Management and Budget Approval; Tobacco Products, Exemptions From Substantial Equivalence... Administration (FDA) is announcing that a collection of information entitled ``Tobacco Products, Exemptions From... submitted a proposed collection of information entitled ``Tobacco Products, Exemptions From...

  3. 76 FR 72710 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND... 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...

  4. 76 FR 70461 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-14

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (FDA Form 3671)'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  5. 78 FR 26783 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of 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...

  6. 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

  7. 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

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

  8. TOMORROW: EPA Administrator in Chicago to Tour Coalition: Energy and Announce Target of Installing One Million New Smart Thermostats Initiative

    EPA Pesticide Factsheets

    CHICAGO - Tomorrow, EPA Administrator Gina McCarthy will tour Coalition: Energy and join state and local leaders in a press conference to announce a new smart thermostat initiative for Illinois with a target of installing one million smart thermosta

  9. TODAY: EPA Administrator in Chicago to Tour Coalition: Energy and Announce Target of Installing One Million New Smart Thermostats Initiative

    EPA Pesticide Factsheets

    CHICAGO - Today, EPA Administrator Gina McCarthy will tour Coalition: Energy and join state and local leaders in a press conference to announce a new smart thermostat initiative for Illinois with a target of installing one million smart thermostats

  10. Food and Drug Administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients.

    PubMed

    Maxey, Dawn M; Ivy, D Dunbar; Ogawa, Michelle T; Feinstein, Jeffrey A

    2013-10-01

    Because most medications for pediatric pulmonary hypertension (PH) are used off label and based on adult trials, little information is available on pediatric-specific adverse events (AEs). Although drug manufacturers are required to submit postmarket AE reports to the Food and Drug Administration (FDA), this information is rarely transmitted to practitioners. In the setting of a recent FDA warning for sildenafil, the authors sought to give a better description of the AEs associated with current therapies in pediatric PH. In January 2010, a written request was made to the Food and Drug Administration for AE records of commonly used PH medications. Reports were screened for pediatric patients, analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, AEs that could be attributed to concomitant medications were not attributed to the PH medication in question. Adverse events occurring in more than 5 % of events for each drug were assumed to be associated with the targeted PH medication. Between November 1997 and December 2009, 588 pediatric AE reports (death in 257 cases) were reported for the three most commonly used therapies: bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those reported previously. However, 27 AEs not previously reported in the literature (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA postmarket records for PH medications in pediatric patients show a significant number of AEs. The discovery of AEs not previously reported will better inform those caring for these complex and critically ill children, and the large number of deaths suggest they may be underreported in current literature.

  11. The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

    PubMed

    Adamovich, Ashley; Park, Susie; Siskin, Gary P; Englander, Meridith J; Mandato, Kenneth D; Herr, Allen; Keating, Lawrence J

    2015-09-01

    The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.

  12. Rationale, Procedures, and Response Rates for the 2015 Administration of NCI’s Health Information National Trends Survey: HINTS-FDA 2015

    PubMed Central

    BLAKE, KELLY D.; PORTNOY, DAVID B.; KAUFMAN, ANNETTE R.; LIN, CHUNG-TUNG JORDAN; LO, SERENA C.; BACKLUND, ERIC; CANTOR, DAVID; HICKS, LLOYD; LIN, AMY; CAPORASO, ANDREW; DAVIS, TERISA; MOSER, RICHARD P.; HESSE, BRADFORD W.

    2016-01-01

    The National Cancer Institute (NCI) developed the Health Information National Trends Survey (HINTS) to monitor population trends in cancer communication practices, information preferences, health risk behaviors, attitudes, and cancer knowledge. The U.S. Food and Drug Administration (FDA) recognized HINTS as a unique data resource for informing its health communication endeavors and partnered with NCI to field HINTS-FDA 2015. HINTS-FDA 2015 was a self-administered paper instrument sent by mail May 29 to September 8, 2015, using a random probability-based sample of U.S. postal addresses stratified by county-level smoking rates, with an oversampling of high and medium-high smoking strata to increase the yield of current smokers responding to the survey. The response rate for HINTS-FDA 2015 was 33% (N = 3,738). The yield of current smokers (n = 495) was lower than expected, but the sampling strategy achieved the goal of obtaining more former smokers (n = 1,132). Public-use HINTS-FDA 2015 data and supporting documentation have been available for download and secondary data analyses since June 2016 at http://hints.cancer.gov. NCI and FDA encourage the use of HINTS-FDA for health communication research and practice related to tobacco-related communications, public knowledge, and behaviors as well as beliefs and actions related to medical products and dietary supplements. PMID:27892827

  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. Erythrityl tetranitrate; drug efficacy study implementation; revocation of exemption; opportunity for a hearing--FDA. Notice.

    PubMed

    1998-06-23

    The Food and Drug Administration (FDA) is revoking the temporary exemption that has allowed single-entity coronary vasodilator drug products containing erythrityl tetranitrate to remain on the market beyond the time limits scheduled for implementation of the Drug Efficacy Study. FDA is announcing that the products lack substantial evidence of effectiveness and is offering an opportunity for a hearing on a proposal to withdraw approval of any applicable new drug applications (NDA's) or abbreviated new drug applications (ANDA's).

  15. 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...

  16. 77 FR 38302 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Office of Management and Budget Approval; Implementation of the Food and Drug Administration Amendments... Administration (FDA) is announcing that a collection of information entitled ``Implementation of the Food and Drug Administration Amendments Act of 2007'' has been approved by the Office of Management and...

  17. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health... Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph...

  18. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global...: The Food and Drug Administration (FDA), Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing...

  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. EPA Administrator McCarthy to announce San Franciscos City Hall becoming the nations oldest building to receive LEED Platinum Green Building Certification

    EPA Pesticide Factsheets

    SAN FRANCISCO - U.S. Environmental Protection Agency Administrator Gina McCarthy will join San Francisco officials, to announce City Hall becoming the oldest building in the nation to receive LEED Platinum Certification for Existing Buildings.

  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. 75 FR 63489 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... Office of Management and Budget Approval; Product Jurisdiction: Assignment of Agency Component for Review... Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Product... Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER...

  4. 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...

  5. 78 FR 54899 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Office of Management and Budget Approval; Recordkeeping Requirements for Medicated Feed Mill License... Administration (FDA) is announcing that a collection of information entitled, ``Medicated Feed Mill License... Feed Mill License Application,'' to OMB for review and clearance under 44 U.S.C. 3507. An Agency...

  6. 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...

  7. 77 FR 37413 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

    ... Office of Management and Budget Approval; Data to Support Communications Usability Testing, as Used by...: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Data... approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995....

  8. 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…

  9. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  10. 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)

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-07

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

  13. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Antibodies to Borrelia Burgdorferi; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  14. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  15. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

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

  16. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Glucose Suspend Device Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  17. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled...

  18. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  19. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

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

  20. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  1. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  2. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Radiology Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  3. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Staphylococcus aureus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  4. 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...

  5. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

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

  6. FDA Issues Anesthesia Warning for Pregnant Women, Kids Under 3

    MedlinePlus

    ... gov/news/fullstory_162543.html FDA Issues Anesthesia Warning for Pregnant Women, Kids Under 3 A long ... latest published studies, the agency announced that these warnings need to be added to the labels of ...

  7. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

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

  8. 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...

  9. 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...

  10. 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...

  11. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 78 FR 9701 - Draft Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... HUMAN SERVICES Food and Drug Administration Draft Joint Food and Drug Administration/Health Canada... and Canada AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft ``Joint Food and Drug...

  13. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... 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...

  14. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this...

  15. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class...

  16. 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...

  17. 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…

  18. FDA’s (Federal Drug Administration) Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies

    DTIC Science & Technology

    1988-09-01

    and the reliability of test data submitted to FDA in support of new drug applications. GAO reviewed the Division’s activities, including its...responsibilities relating to the approval of new drug and biologic products; the accuracy of FDA data and adequacy of oversight regarding clinical...investigators, institutional review boards, and toxicology laboratories involved in studies supporting new drug applications; FDA’s review of studies by clinical

  19. [U.S. Food and Drug Administration (FDA) strengthens warning that non-aspirin non steroidal anti-inflammatory drugs (NSAIDs) can cause myocardial infarctions or strokes: the dentist's perspective].

    PubMed

    Rosen, E; Tsesis, I; Vered, M

    2015-10-01

    This short communication is aimed to update dental practitioners regarding the recently published warning of the U.S. Food and Drug Administration (FDA) regarding the risk for severe cardiovascular complications such as myocardial infarction or stroke following the use of non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs).

  20. Acute stroke therapy with tissue plasminogen activator (tPA) since it was approved by the U.S. Food and Drug Administration (FDA).

    PubMed

    Zivin, Justin A

    2009-07-01

    Tissue plasminogen activator (tPA) for acute ischemic stroke was approved by the U.S. Food and Drug Administration (FDA) in 1996. Since then it has been severely underutilized. At the time when most practitioners were first being exposed to the literature concerning tPA, there were many concerns about safety and the restrictions on use were quite onerous. Since then a good deal of further work has been done to loosen the restrictions and allay concerns about the risks. The true risk to benefit ratio is far better than is generally realized. Now it is mostly economic problems related to the costs of constantly supplying emergency care that is limiting access. Furthermore, in the current litigious environment, failure to treat is likely to be a more hazardous course of action than legal exposure due to poor outcomes. It must be emphasized that the drug is quite safe and highly effective, and current utilization rates are unacceptably low. Ann Neurol 2009;66:6-10.

  1. 75 FR 32953 - Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Use...

  2. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.

    PubMed

    1998-04-10

    The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.

  3. 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

    ... appropriate technologies that enhance the tracking and tracing of foods along the supply chain from source to... ingredients (minimum of two ingredients) and (b) a selected fruit and/or vegetable along the supply chain; 7... along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders...

  4. 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…

  5. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati,...

  6. 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... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati,...

  7. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    PubMed

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications.

  8. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  9. 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.

  10. A dual track system to give more-rapid access to new drugs: applying a systems mindset to the US food and drug administration (FDA).

    PubMed

    Madden, Bartley J

    2009-02-01

    A widely applicable lesson learned from systems analysis is that a proposed change should always be studied in terms of value to the customer and not a gain in efficiency of any particular component of the system. A systems mindset reveals invalid assumptions that have caused the FDA to substitute its own needs for the needs of its customers (patients). Further, the key constraint to overall system improvement is the lack of consumer choice and competition due to FDA's monopoly over access to drugs. Therefore, we need legislation to implement a proposed dual track system for access to drugs that have successfully passed Phase I safety trials. On one track, an experimental drug would continue with conventional FDA clinical trials. On a new, free-to-choose track, patients, advised by their doctors, would make informed decisions about immediate access to not-yet-approved drugs. Internet access to a government-operated tradeoff evaluation database would provide patients and doctors with up-to-date information on all drug treatment outcomes for both tracks. Dual tracking is a dynamic process that overcomes the limitations of a static FDA regulatory process that ignores individual risk preferences.

  11. 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.

  12. FDA Warns Against Bogus Autism 'Cures'

    MedlinePlus

    ... news/fullstory_164602.html FDA Warns Against Bogus Autism 'Cures' Unproven therapies won't help and could ... Don't fall for products claiming to cure autism, the U.S. Food and Drug Administration warns. There's ...

  13. 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...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Administration on Children, Youth and Families... national organizations to enhance NRS' national impact in crisis intervention for youth and families....

  15. 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.

  16. 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.

  17. Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review.

    PubMed

    Tyner, Katherine; Sadrieh, Nakissa

    2011-01-01

    The Food and Drug Administration (FDA) does not, as yet, have specific guidances for products containing nanoscale materials. As announced in the report issued by the FDA Nanotechnology Task Force (July 2007), however, there are recommendations to various centers within the FDA to develop guidances for industry. Regardless of the lack of explicit FDA guidances, there are therapeutics currently on the market containing nanoscale materials, and additional novel nanomaterial-containing therapeutics are being developed with the hopes of being submitted for regulatory review and approval. While, for the most part, these novel nanomaterial-containing products are being evaluated using the same regulatory requirements as products that do not contain nanomaterials, it is increasingly evident that at least in the area of characterization of nanomaterials used in drug products, there may be areas where special focus is needed. Specific areas include the validity of applying small molecule principles and methodologies to nanomaterial-containing products, the effects the nanomaterial will impart to the rest of the formulation (or vice versa), and how the physicochemical properties may be impacted by biological settings. Similarly, for safety evaluation, biodistribution studies will be at the core of any evaluation of products containing nanomaterials. These biodistribution studies will, in effect, be indicative of where the nanoparticles are traveling and possibly accumulating, therefore subjecting those sites to increased likelihood of toxicological effects. This chapter focuses on questions and considerations that may arise for sponsors during product characterization, as well as considerations for the appropriate design and conduct of in vivo toxicology studies. This chapter will also review how current FDA guidances apply to nanotherapeutics.This chapter reflects the current thinking and experience of the authors. However, this is not a policy document and should not be

  18. SmartTots: a public-private partnership between the United States Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS).

    PubMed

    Ramsay, James G; Roizen, Michael

    2012-10-01

    A history of the public-private partnership 'SmartTots' between the IARS and FDA is presented. In order to raise money for research to better understand the relationship between sedative and anesthetic agents and neurotoxicity in the developing brain, the FDA approached the IARS in 2008. A partnership was developed over the following 2 years, then a Scientific Advisory Board was created to develop a research agenda. The IARS contributed $200 000 in 2011 to provide initial funding; 33 proposals were submitted in response to a request for proposals in late 2011 and resulted in the awarding of two, $100 000 grants in 2012. An Executive Board was appointed under the leadership of Michael Roizen to spearhead additional fund-raising efforts, and a director of development is working with Dr. Roizen and the Board to raise funds from individuals and organizations. Dr. Roizen has personally committed to a matching grant for anesthesiologists, up to $50 000 per year for 20 years ($1 million). Readers of the journal are encouraged to go to the website www.smarttots.org in order to better understand the issue, to contribute to the research fund themselves, and to encourage their own professional organizations to partner with SmartTots in fund-raising.

  19. FDA Certified Mammography Facilities

    MedlinePlus

    ... Program Consumer Information (MQSA) Search for a Certified Facility Share Tweet Linkedin Pin it More sharing options ... Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on Search ...

  20. FDA Certified Mammography Facilities

    MedlinePlus

    ... Products Radiation-Emitting Products Home Radiation-Emitting Products Mammography Quality Standards Act and Program Consumer Information (MQSA) ... it Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on ...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. Attestations by facilities using nonimmigrant aliens as registered nurses--Employment and Training Administration and Employment Standards Administration, Labor--Final rule and amendment and announcement of effective date.

    PubMed

    1994-02-04

    On January 6, 1994, the Employment and Training Administration (ETA) and the Wage and Hour Division of the Employment Standards Administration of the Department of Labor published final regulations governing the filing and enforcement of attestations by health care facilities seeking to use the services of nonimmigrant aliens as registered nurses under H-1A visas. At that time, ETA submitted the information collection requirements to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980. This document amends the January 6, 1994, Federal Register document to display the OMB control numbers and announces the effective date for the sections containing information collection requirements for which OMB approval has been received.

  7. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.

    PubMed

    Rossen, Benjamin R

    2009-01-01

    On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs. The proposals come at a time when FDA has found itself under new pressure to provide seriously ill patients with early access to investigational drugs outside the framework of clinical trials. In recent years, patient advocacy groups have filed citizen petitions with FDA asking the agency to provide specific criteria to patients and sponsors seeking expanded access or to create an early approval mechanism to permit easier access to investigational therapies. Further, FDA has seen proposed federal legislation intended to ensure early patient access to investigational treatments and nearly lost a lawsuit in federal court in which terminally ill patients sought a fundamental right of access to investigational therapies under the Due Process Clause of the Constitution. The proposed rules seek to assuage patient activists, physicians, drug sponsors and other critics who contend that FDA must strike an appropriate balance between allowing patient access to promising treatments while protecting against undue risk and safeguarding the clinical trials process. Although FDA heralded the announcement of the rules as a key step forward to improving patient access, the proposal does not expand access beyond measures currently available under longstanding agency practice and, in fact, creates new regulatory barriers and disincentives to industry participation in expanded access programs. This article examines the proposal in light of historical agency regulation and recent pressures to expand access. Section II describes the historical development of FDA's statutory authority to regulate drugs and the traditional new drug approval process. Section III describes the various methods through which FDA has allowed expanded access to

  8. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program; Availability... (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary... guidance document entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot...

  9. 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.

  10. Is It Really FDA Approved?

    MedlinePlus

    ... FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers ... dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device ...

  11. 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.

  12. The FDA and the new biology.

    PubMed

    Simari, Robert D; Chen, Horng; Burnett, John C

    2008-12-01

    The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval.

  13. FDA Drug Approval: Review Time Has Decreased in Recent Years.

    DTIC Science & Technology

    1995-10-01

    New drugs marketed in the United States must be approved first by the Food and Drug Administration (FDA). Approval comes after FDA has determined...reform argue that shortening the time it takes to get new drugs approved will contribute both to public health, by making effective therapies

  14. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  15. The FDA's program for monitoring radionuclides in food

    SciTech Connect

    Baratta, E.J. )

    1992-01-01

    The US Food and Drug Administration (FDA) modified its food-monitoring program in 1973 to include radioactive isotopes. There was concern at this time about the possibility of food contamination by effluents from nuclear power plants, some above-ground weapons testing by nonsignatory powers, and increased use of medical and commercial radioactive materials. The FDA decided, therefore, that a radioanalytical capability must be maintained to detect any upward trend of radioactive contamination in food. This capability would also allow the FDA to respond to any incidents that might occur in order to protect the US food supply. This program is located at the FDA's Winchester Engineering and Analytical Center, Winchester, Massachusetts.

  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.

  17. 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

  18. 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.

  19. 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

  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. 22 CFR 708.4 - Public announcement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Public announcement. 708.4 Section 708.4 Foreign Relations OVERSEAS PRIVATE INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS SUNSHINE REGULATIONS § 708.4 Public announcement. (a) Except to the extent that such information is exempt from disclosure under...

  2. 22 CFR 708.4 - Public announcement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Public announcement. 708.4 Section 708.4 Foreign Relations OVERSEAS PRIVATE INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS SUNSHINE REGULATIONS § 708.4 Public announcement. (a) Except to the extent that such information is exempt from disclosure under...

  3. 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...

  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 Recruitment and Selection Program § 1214.1101 Announcement. (a) Astronaut candidate opportunities Will...

  5. 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...

  6. 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...

  7. 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...

  8. 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.

  9. 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

    • FDA's evolving approach to nanotechnology.

      PubMed

      Monica, John C

      2012-01-01

      Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several years, questions concerning the effectiveness of existing regulations have emerged. After a period of study and analysis, the FDA has issued three (3) draft guidance documents over the last eighteen (18) months pertaining to the use of nanoscale materials and nanotechnology in certain FDA-regulated products. As these are likely to become the "de facto" standards they merit further analysis. This article examines these draft guidance documents and provides modest commentary for those practicing in the area.

    • 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.

    • 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

    • Medical devices; reconditioners, rebuilders of medical devices; revocation of compliance policy guide; request for comments--FDA. Notice.

      PubMed

      1998-12-04

      The Food and Drug Administration (FDA) is revoking Compliance Policy Guide (CPG) 7124.28 because application of current good manufacturing practice (CGMP) requirements to "reconditioners/rebuilders" of used medical devices does not comport with definitions in the quality system (QS) regulation or guidance in the final rule that applies CGMP requirements to "manufacturers" and "remanufacturers." Because "reconditioners/rebuilders" are specifically excluded from the definition of "manufacturer" or "remanufacturer" in the QS regulation, guidance in the CPG on the applicability of registration, listing, and other statutory and regulatory requirements to "reconditioners/rebuilders" does not represent current agency thinking. In the advance notice of proposed rulemaking (ANPRM), published in the December 23, 1997, Federal Register, FDA announced its intention to consider identifying the used device market, for regulatory purposes, in terms of "refurbishers," "as-is remarketers," and "servicers" whose activities do not significantly change the safety, performance, or use of a device, and to examine alternative approaches for regulating these firms. Pending the issuance of a rule or guidance setting forth FDA's current position, CPG 7124.28 is being revoked to eliminate obsolete guidance and reduce industry burdens.

    • 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

    • 21 CFR 530.23 - Procedure for setting and announcing safe levels.

      Code of Federal Regulations, 2012 CFR

      2012-04-01

      ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Procedure for setting and announcing safe levels... for setting and announcing safe levels. (a) FDA may issue an order establishing a safe level for a... in the Federal Register a notice of the order. The notice will include: (1) A statement setting...

    • 21 CFR 530.23 - Procedure for setting and announcing safe levels.

      Code of Federal Regulations, 2014 CFR

      2014-04-01

      ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Procedure for setting and announcing safe levels... for setting and announcing safe levels. (a) FDA may issue an order establishing a safe level for a... in the Federal Register a notice of the order. The notice will include: (1) A statement setting...

    • Regulating nanomedicine - can the FDA handle it?

      PubMed

      Bawa, Raj

      2011-05-01

      There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle

    • Examining the FDA's oversight of direct-to-consumer advertising.

      PubMed

      Gahart, Martin T; Duhamel, Louise M; Dievler, Anne; Price, Roseanne

      2003-01-01

      Our analysis examined the effects of the Food and Drug Administration's (FDA's) 1997 draft guidance regarding advertisements for prescription drugs broadcast directly to consumers. We found that although direct-to-consumer (DTC) advertising spending by pharmaceutical companies has increased, more than 80 percent of their promotional spending is directed to physicians. DTC advertising appears to increase the use of prescription drugs among consumers. The FDA's oversight has not prevented companies from making misleading claims in subsequent advertisements, and a recent policy change has lengthened the FDA's review process, raising the possibility that some misleading campaigns could run their course before review.

    • FDA perspective: enrolment of elderly transplant recipients in clinical trials.

      PubMed

      Meyer, Joette M; Archdeacon, Patrick; Albrecht, Renata

      2013-04-15

      Since 1989, the U.S. Food and Drug Administration (FDA) has encouraged the study of new drug and therapeutic products in elderly patients. However, despite the aging population in the United States, elderly patients continue to be underrepresented in clinical trials across a variety of therapeutic areas, including transplantation. The currently available tools for the FDA to encourage and require the evaluation and reporting of safety and efficacy information in elderly patients are summarized. Clinicians, sponsors, and investigators are encouraged to work with the FDA to expand the enrolment of elderly patients in clinical trials of transplantation.

    • Food and Drug Administration

      MedlinePlus

      ... blog post. April 11, 2017 ‘Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science More FDA Voice Blog ... FEAR Act Site Map Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver ...

  1. 12 CFR 604.425 - Announcement of meetings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Announcement of meetings. 604.425 Section 604.425 Banks and Banking FARM CREDIT ADMINISTRATION ADMINISTRATIVE PROVISIONS FARM CREDIT ADMINISTRATION BOARD MEETINGS § 604.425 Announcement of meetings. (a) The Board meets in the offices of the Farm...

  2. FDA-Approved HIV Medicines

    MedlinePlus

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with ... 2007 Pharmacokinetic Enhancers Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine ...

  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. 5 CFR 1632.6 - Public announcement of meetings.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Public announcement of meetings. 1632.6 Section 1632.6 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD RULES REGARDING PUBLIC OBSERVATION OF MEETINGS § 1632.6 Public announcement of meetings. (a) Except as otherwise provided by the...

  5. 5 CFR 1632.6 - Public announcement of meetings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Public announcement of meetings. 1632.6 Section 1632.6 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD RULES REGARDING PUBLIC OBSERVATION OF MEETINGS § 1632.6 Public announcement of meetings. (a) Except as otherwise provided by the...

  6. FDA regulation of tobacco: blessing or curse for FDA professionals?

    PubMed

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

  7. 76 FR 42712 - Announcement of Grant Award

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... HUMAN SERVICES Administration for Children and Families Announcement of Grant Award AGENCY: Office of... Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Community... economic asset. AFI project families use their IDA savings, including the matching funds, to achieve any...

  8. Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation.

    PubMed

    1997-12-19

    The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.

  9. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and...

  10. 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

    ...; 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 Tobacco... questions that FDA has received regarding the issuance of civil money penalties for violations...

  11. 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 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  12. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 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,...

  13. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 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,...

  14. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 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,...

  15. 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.

  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. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Processing...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at...

  18. 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... Tobacco Dependence; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA)...

  19. 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)...

  20. 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)...

  1. Bayesian statistics in medical devices: innovation sparked by the FDA.

    PubMed

    Campbell, Gregory

    2011-09-01

    Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.

  2. 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…

  3. 21 CFR 830.220 - Termination of FDA service as an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency. 830.220 Section 830.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... be likely to lead to a return of the conditions that prompted us to act. (b) If FDA has ended...

  4. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

  5. Drug development in inflammatory bowel disease: the role of the FDA.

    PubMed

    Lahiff, Conor; Kane, Sunanda; Moss, Alan C

    2011-12-01

    All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.

  6. The FDA and designing clinical trials for chronic cutaneous ulcers.

    PubMed

    Maderal, Andrea D; Vivas, Alejandra C; Eaglstein, William H; Kirsner, Robert S

    2012-12-01

    Treatment of chronic wounds can present a challenge, with many patients remaining refractory to available advanced therapies. As such, there is a strong need for the development of new products. Unfortunately, despite this demand, few new wound-related drugs have been approved over the past decade. This is in part due to unsuccessful clinical trials and subsequent lack of Food and Drug Administration (FDA) approval. In this article, we discuss the FDA approval process, how it relates to chronic wound trials, common issues that arise, and how best to manage them. Additionally, problems encountered specific to diabetic foot ulcers (DFU) and venous leg ulcers (VLU) are addressed. Careful construction of a clinical trial is necessary in order to achieve the best possible efficacy outcomes and thereby, gain FDA approval. How to design an optimal trial is outlined.

  7. 45 CFR 63.3 - Program announcements and solicitations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Program announcements and solicitations. 63.3 Section 63.3 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS... announcements and solicitations. (a) In each fiscal year the Assistant Secretary may from time to time...

  8. Pharmaceutical trademarks: navigating through the FDA's pilot program.

    PubMed

    Ferrer, Elisa

    2010-06-01

    Creation and clearance of pharmaceutical trademarks continues to be one of the most difficult and challenging areas of trademark law. The Food and Drug Administration (FDA) recently initiated a 2-year Pilot Program under Prescription Drug User Fee Act (PDUFA) IV. The intent of the program is to enable participating pharmaceutical firms to evaluate proposed pharmaceutical marks and submit the data generated from those evaluations to the FDA for review. Submitting a trademark to the FDA warrants questions: What supporting data is needed and accepted when proposing a mark? What issues might arise, and how can they be averted? In a recent Thomson Reuters on-demand webinar (http://science.thomsonreuters.com/news/2010-02/8580404/), a group of renowned experts in the field of trademark development review the FDA pilot program, outline the requirements for submission and discuss what the changes will mean in clearing new pharmaceutical marks. They also present various approaches to trademark development and evaluation in light of the FDA's views.

  9. A hard look at FDA's review of GRAS notices.

    PubMed

    Roberts, Ashley; Haighton, Lois A

    2016-08-01

    Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of "reasonable certainty of no harm" is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of "FDA has no questions", "Notice does not provide a basis for a GRAS determination", or, "At Notifier's request, FDA ceased to evaluate the notice." Of 528 notices reviewed, there were 393 "no questions letters", 17 "insufficient basis letters", and 84 "cease to evaluate letters". Of those deemed to be insufficient, most failed to meet the general recognition criteria. Only four raised questions about potential safety, of which three received a no questions letter upon providing more data. Of the 84 withdrawn notices, 22 received a no questions letter upon resubmission. In spite of criticisms, the FDA GRAS notice process is clearly defined, efficient, and cost-effective, and there have been no known public health issues following its implementation.

  10. 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...

  11. A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.

    PubMed

    Keatley, K L

    1999-01-01

    Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.

  12. 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. |

  13. Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

    Cancer.gov

    This metric 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.

  14. 75 FR 67965 - Announcement of Local Government Advisory Committee Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    .... Environmental Protection Agency announces that Administrator Lisa P. Jackson has appointed 29 local, State, and... Peterson, Mayor, Ithaca, New York. Lisa A.Wong, Mayor, Fitchburg, Massachusetts. David W. Smith,...

  15. Characteristics of pivotal trials and FDA review of innovative devices.

    PubMed

    Rising, Joshua P; Moscovitch, Ben

    2015-01-01

    When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies--and contributing factors, such as primary outcome measures and enrollment--could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues.

  16. Characteristics of Pivotal Trials and FDA Review of Innovative Devices

    PubMed Central

    Rising, Joshua P.; Moscovitch, Ben

    2015-01-01

    When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies—and contributing factors, such as primary outcome measures and enrollment—could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues. PMID:25651420

  17. 5 CFR 2413.6 - Notice of meetings; public announcement and publication.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Notice of meetings; public announcement... PROVISIONS OPEN MEETINGS § 2413.6 Notice of meetings; public announcement and publication. (a) A public...), the agency shall make public announcement of each meeting to be held at least seven (7) days...

  18. 5 CFR 2413.6 - Notice of meetings; public announcement and publication.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Notice of meetings; public announcement... PROVISIONS OPEN MEETINGS § 2413.6 Notice of meetings; public announcement and publication. (a) A public...), the agency shall make public announcement of each meeting to be held at least seven (7) days...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 5 CFR 1632.8 - Changes with respect to publicly announced meetings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... announced meetings. 1632.8 Section 1632.8 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD RULES REGARDING PUBLIC OBSERVATION OF MEETINGS § 1632.8 Changes with respect to publicly announced... meeting to public observation may be changed following public announcement under § 1632.6 only if...

  5. 5 CFR 1632.8 - Changes with respect to publicly announced meetings.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... announced meetings. 1632.8 Section 1632.8 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD RULES REGARDING PUBLIC OBSERVATION OF MEETINGS § 1632.8 Changes with respect to publicly announced... meeting to public observation may be changed following public announcement under § 1632.6 only if...

  6. Current FDA-approved treatments for Helicobacter pylori and the FDA approval process.

    PubMed

    Hopkins, R J

    1997-12-01

    U.S. Food and Drug Administration (FDA) approval of new drugs expands treatment options and serves as a "safety net" of well-documented efficacy and safety. The information provided in the package insert facilitates physician education and provides some assurance that marketing information is accurate. As of February 1997, three Helicobacter pylori regimes have been FDA-approved for eradication of H. pylori in infected patients with active duodenal ulcers. Regimen 1, omeprazole + clarithromycin (O/C), was supported by two multicenter, controlled studies with a 6-month follow-up. Eradication rates were 74% (n = 53; 95% confidence interval [CI], 62-85) and 64% (n = 61; 95% CI, 52-76). Twenty-five of 26 patients with failed eradication therapy who were taking O/C with clarithromycin-susceptible strains before treatment and who had pretreatment and posttreatment susceptibility tests performed developed clarithromycin resistance after treatment. Regimen 2, ranitidine-bismuth-citrate + clarithromycin, was supported by two multicenter, placebo-controlled studies with a 6-month follow-up. Eradication rates were 84% (n = 19; 95% CI, 60-96) and 73% (n = 22; 95% CI, 50-88). Insufficient pretreatment and posttreatment susceptibility data were collected to assess antimicrobial resistance. Regimen 3, bismuth subsalicylate + metronidazole + tetracycline + an H2-receptor antagonist, was supported by two pivotal literature-based studies. Eradication rates in patients with duodenal ulcer were 82% (n = 51; 95% CI, 70-92) and 77% (n = 39; 95% CI, 61-89), respectively. When extrapolating the results of these three FDA-approved regimens to the clinical setting, particular aspects of the clinical trial should be kept in mind. These include the type of controls, primary end points used, population studied, and number and type of dropouts.

  7. 75 FR 67983 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    .... FDA-2009-N-0098] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Potential Data Sources for the Sentinel Initiative AGENCY: Food and Drug... collection of information entitled ``Evaluation of Potential Data Sources for the Sentinel Initiative''...

  8. 77 FR 5295 - Over-the-Road Bus Accessibility Program Announcement of Project Selections

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    ... TRANSPORTATION Federal Transit Administration Over-the-Road Bus Accessibility Program Announcement of Project Selections AGENCY: Federal Transit Administration (FTA), DOT. ACTION: Notice. SUMMARY: The U.S. Department of Transportation (DOT) Federal Transit Administration (FTA) announces the selection of projects to be funded...

  9. 77 FR 23732 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations...'' AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  10. 76 FR 13623 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act AGENCY: Food and Drug Administration, HHS. ACTION:...

  11. 76 FR 2123 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice Quality System Regulation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  12. 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. PMID:27774193

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

    PubMed

    Willmarth, Kirk

    2015-02-01

    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.

  14. The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials.

    PubMed

    Marchetti, S; Schellens, J H M

    2007-09-03

    An increase in the number of identified therapeutic cancer targets achieved through recent biomedical research has resulted in the generation of a large number of molecules that need to be tested further. Current development of (anticancer) drugs is a rather inefficient process that for an average new molecule takes around 10-15 years. It is also a challenging process as it is associated with high costs and a low rate of approval. It is known that less than 10% of new molecular entities entering clinical Phase I testing progress beyond the investigational programme and reach the market; this probability is even lower for anticancer agents. In 2003, the US Food and Drug Administration (US FDA) declared the urgent need for new toolkits to improve the critical development path that leads from scientific discovery to the patient. In this scenario, Phase 0 (zero) trials should allow an early evaluation in humans of pharmacokinetic and pharmacodynamic profiles of test compounds through administration of sub-pharmacological doses and for a short time period to a low number of humans. Typically, Phase 0 studies have no therapeutic or diagnostic intent. Owing to the low doses administered and the low risk of toxicity, shorter preclinical packages to support these studies are required. Phase 0 trials have been proposed to help in making an early selection of promising candidates for further evaluation in Phase I-III trials, providing a potentially useful instrument for drug discovery, particularly in the field of oncology. Phase 0 studies are expected to reduce costs of drug development, and to limit the preclinical in vitro and in vivo testing and the time period of drug development. However, there are also concerns about the utility and feasibility of Phase 0 studies. In January 2006, guidelines on exploratory investigational new drug studies in humans have been published by the US FDA, and currently a Phase 0 programme is ongoing at the National Cancer Institute to

  15. 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)

  16. 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].

  17. Rehabilitation Services Administration

    MedlinePlus

    ... Contacts OSEP Reports & Resources RSA Welcome to RSA Rehabilitation Services Administration RSA Spotlight News Commissioner's Quarterly Newsletter ... The Office of Special Education and Rehabilitative Services’ Rehabilitation Services Administration is proud to announce the publication ...

  18. Implications of the FDA statement on transvaginal placement of mesh: the aftermath.

    PubMed

    Koski, Michelle E; Rovner, Eric S

    2014-02-01

    The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18-24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.

  19. 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.

  20. Turning point or tipping point: new FDA draft guidances and the future of DTC advertising.

    PubMed

    Pitts, Peter J

    2004-01-01

    According to Food and Drug Administration (FDA) research, direct-to-consumer (DTC) drug ads are not as empowering as they were even three years ago. How will the FDA's new draft guidances reverse this trend and affect the future of DTC advertising? Will they be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative, or a tipping point with politicians and the public zeroing in on aggressively targeted DTC ads as the postimportation pharmaceutical bête noire? The FDA believes that its new guidances strengthen the strategic argument that a better-informed consumer lays the groundwork for a better potential customer.

  1. 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.

  2. Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.

    PubMed

    1998-02-02

    The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.

  3. FDA/CVM's Compliance Policy Guide on compounding of drugs.

    PubMed

    1996-12-15

    As a veterinary practitioner, do you combine drug agents for anesthesia? Create antidotes? Dilute liquids for administration to small, young, or exotic species? Such efforts are examples of compounding. The FDA/CVM's new Compliance Policy Guide (CPG), which regulates the compounding of drugs by veterinarians and pharmacists for use in animals appears here, as originally published in the Compliance Policy Guide Manual. The CPG provides guidance to FDA's field and headquarters staff and serves as a source of useful information to veterinarians. The CPG for Compounding of Drugs for Use in Animals reflects the efforts of a task force made up of a diverse group of veterinarians, pharmacists, and regulators whose conclusions were published in the Symposium of Compounding in JAVMA, July 15, 1994, pp 189-303.

  4. 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.

  5. 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.

  6. 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

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  7. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  8. 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

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  9. 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

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  10. 77 FR 52036 - Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Records Related to Research Misconduct Proceedings AGENCY: Food and Drug Administration, HHS. ACTION... Related to Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020. Under the Department of... Misconduct, FDA has responsibilities for addressing research integrity and misconduct issues related to...

  11. New Eczema Drug Gets FDA's Blessing

    MedlinePlus

    ... page: https://medlineplus.gov/news/fullstory_164327.html New Eczema Drug Gets FDA's Blessing Injections may ease ... News) -- Adults plagued by eczema may have a new treatment option, with a new drug approved Tuesday ...

  12. FDA Suggests Limits on Lead in Cosmetics

    MedlinePlus

    ... 162726.html FDA Suggests Limits on Lead in Cosmetics Agency notes most products already below recommended level ... limit on how much lead can be in cosmetics ranging from lipstick and eye shadow to blush ...

  13. 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®)

  14. 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…

  15. 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.

  16. What's next after 50 years of psychiatric drug development: an FDA perspective.

    PubMed

    Laughren, Thomas P

    2010-09-01

    This article discusses changes in psychiatric drug development from a US Food and Drug Administration (FDA) standpoint. It first looks back at changes that have been influenced by regulatory process and then looks forward at FDA initiatives that are likely to affect psychiatric drug development in the future. FDA protects the public health by ensuring the safety and efficacy of drug products introduced into the US market. FDA works with drug sponsors during development, and, when applications are submitted, reviews the safety and efficacy data and the proposed labeling. Drug advertising and promotion and postmarketing surveillance also fall within FDA's responsibility. Among the many changes in psychiatric drug development over the past 50 years, several have been particularly influenced by FDA. Populations studied have expanded diagnostically and demographically, and approved psychiatric indications have become more focused on the clinical entities actually studied, including in some cases specific symptom domains of recognized syndromes. Trial designs have become increasingly complex and informative, and approaches to data analysis have evolved to better model the reality of clinical trials. This article addresses 2 general areas of innovation at FDA that will affect psychiatric drug development in years to come. Several programs falling under the general heading of the Critical Path Initiative, ie, biomarkers, adaptive design, end-of-phase 2A meetings, and data standards, are described. In addition, a number of important safety initiatives, including Safety First, the Sentinel Initiative, the Safe Use Initiative, and meta-analysis for safety, are discussed.

  17. 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...

  18. 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 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  19. 76 FR 28045 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS....

  20. 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... Testing of Dietary Ingredients; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS....

  1. 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...

  2. 76 FR 17626 - National Climate Assessment Development and Advisory Committee; Announcement of Time Change and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... National Oceanic and Atmospheric Administration National Climate Assessment Development and Advisory... Administration, Department of Commerce. ACTION: National Climate Assessment Development and Advisory Committee... announces a change in the start time and provides the location of the meeting of the National...

  3. 78 FR 22887 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... and Potential Harmful Tobacco Constituents AGENCY: Food and Drug Administration, HHS. ACTION: Notice... ``Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents''...

  4. 78 FR 68029 - Announcement of Changes to the Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... review and make recommendations to the appointing authority on performance management issues such as... International Trade Administration Announcement of Changes to the Membership of the Performance Review Board AGENCY: International Trade Administration, Department of Commerce. ACTION: Notice of Performance...

  5. 76 FR 64073 - Announcement of Changes to the Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Board is to review and make recommendations to the appointing authority on performance management issues... International Trade Administration Announcement of Changes to the Membership of the Performance Review Board AGENCY: International Trade Administration, Department of Commerce. ACTION: Notice of Performance...

  6. 75 FR 36356 - Announcement of Changes to the Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... International Trade Administration Announcement of Changes to the Membership of the Performance Review Board AGENCY: International Trade Administration, Department of Commerce. ACTION: Notice of Performance Review... Performance Review Board appointees in the Federal Register before their service begins. In accordance...

  7. 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...

  8. 5 CFR 315.611 - Appointment of certain veterans who have competed under agency merit promotion announcements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... competed under agency merit promotion announcements. 315.611 Section 315.611 Administrative Personnel... who have competed under agency merit promotion announcements. (a) Agency authority. An agency may... competition under a merit promotion announcement open to candidates outside the agency's workforce; and...

  9. 77 FR 63836 - Announcement of the Award of Two Single-Source Program Expansion Supplements to Grantees Under...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Administration for Children and Families Announcement of the Award of Two Single-Source...: Office of Family Assistance, ACF, HHS. ACTION: Announcement of the award of single-source program... Territory TANF Management (DSTTM) announces the award of single-source program expansion supplement...

  10. Blood donation, deferral, and discrimination: FDA donor deferral policy for men who have sex with men.

    PubMed

    Galarneau, Charlene

    2010-02-01

    U.S. Food and Drug Administration (FDA) policy prohibits blood donation from men who have had sex with men (MSM) even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different approach to analyzing discrimination claims. I draw on an institutional understanding of injustice to discern and describe five features of the MSM policy and its FDA context that contribute to its discriminatory effect. I note significant similarities in the 1980s policy of deferring Haitians, suggesting an historical pattern of discrimination in FDA deferral policy. Finally, I point to changes needed to move toward a nondiscriminatory deferral policy.

  11. 77 FR 20025 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... Office of Management and Budget Approval; Blood Establishment Registration and Product Listing, Form FDA... and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB... Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,...

  12. 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.

  13. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

  14. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

  15. PUBLISHER'S ANNOUNCEMENT: Editorial developments

    NASA Astrophysics Data System (ADS)

    2009-01-01

    We are delighted to announce that from January 2009, Professor Murray T Batchelor of the Australian National University, Canberra will be the new Editor-in-Chief of Journal of Physics A: Mathematical and Theoretical. Murray Batchelor has been Editor of the Mathematical Physics section of the journal since 2007. Prior to this, he served as a Board Member and an Advisory Panel member for the journal. His primary area of research is the statistical mechanics of exactly solved models. He holds a joint appointment in mathematics and physics and has held visiting positions at the Universities of Leiden, Amsterdam, Oxford and Tokyo. We very much look forward to working with Murray to continue to improve the journal's quality and interest to the readership. We would like to thank our outgoing Editor-in-Chief, Professor Carl M Bender. Carl has done a magnificent job as Editor-in-Chief and has worked tirelessly to improve the journal over the last five years. Carl has been instrumental in designing and implementing strategies that have enhanced the quality of papers published and service provided by Journal of Physics A: Mathematical and Theoretical. Notably, under his tenure, we have introduced the Fast Track Communications (FTC) section to the journal. This section provides a venue for outstanding short papers that report new and timely developments in mathematical and theoretical physics and offers accelerated publication and high visibility for our authors. During the last five years, we have raised the quality threshold for acceptance in the journal and now reject over 60% of submissions. As a result, papers published in Journal of Physics A: Mathematical and Theoretical are amongst the best in the field. We have also maintained and improved on our excellent receipt-to-first-decision times, which now average less than 50 days for papers. We have recently announced another innovation; the Journal of Physics A Best Paper Prize. These prizes will honour excellent papers

  16. 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

    ... 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 for Children and Families, Health and Human Services. ACTION: Announcement of the award of a...

  17. Paine Appointed Administrator

    NASA Technical Reports Server (NTRS)

    1969-01-01

    President Richard M. Nixon announcing the appointment of Dr. Thomas O. Paine as Administrator for the National Aeronautics and Space Administration. The ceremony was held at the White House. Paine had been serving as acting administrator. From left to right: President Richard M. Nixon NASA Administrator Dr. Thomas O. Paine Vice President Spiro T. Agnew

  18. Of poops and parasites: unethical FDA overregulation.

    PubMed

    Young, Kenneth A

    2014-01-01

    Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.

    PubMed

    1998-11-12

    The Food and Drug Administration (FDA) is proposing to amend 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 proposing to designate 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 Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

  4. 78 FR 39734 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... FURTHER INFORMATION 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 ....

  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. Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

    PubMed

    Khin, N A; Yang, P; Hung, H M J; Maung-U, K; Chen, Y-F; Meeker-O'Connell, A; Okwesili, P; Yasuda, S U; Ball, L K; Huang, S-M; O'Neill, R T; Temple, R

    2013-08-01

    Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

  7. 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...

  8. 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:...

  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, 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...

  13. 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)...

  14. 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...

  15. 5 CFR 330.105 - Instructions on how to add a vacancy announcement to USAJOBS.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Instructions on how to add a vacancy... Service § 330.105 Instructions on how to add a vacancy announcement to USAJOBS. An agency can find the instructions to add a vacancy announcement to USAJOBS on OPM's Web site at http://www.usajobs.gov....

  16. 5 CFR 330.105 - Instructions on how to add a vacancy announcement to USAJOBS.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Instructions on how to add a vacancy... Service § 330.105 Instructions on how to add a vacancy announcement to USAJOBS. An agency can find the instructions to add a vacancy announcement to USAJOBS on OPM's Web site at http://www.usajobs.gov....

  17. 5 CFR 330.105 - Instructions on how to add a vacancy announcement to USAJOBS.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Instructions on how to add a vacancy... Service § 330.105 Instructions on how to add a vacancy announcement to USAJOBS. An agency can find the instructions to add a vacancy announcement to USAJOBS on OPM's Web site at http://www.usajobs.gov....

  18. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Milk), DEPARTMENT OF AGRICULTURE GENERAL PROVISIONS OF FEDERAL MILK MARKETING ORDERS Class Prices § 1000.53 Announcement of class prices... administrator for each Federal milk marketing order shall announce the following prices (as applicable to...

  19. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Milk), DEPARTMENT OF AGRICULTURE GENERAL PROVISIONS OF FEDERAL MILK MARKETING ORDERS Class Prices § 1000.53 Announcement of class prices... administrator for each Federal milk marketing order shall announce the following prices (as applicable to...

  20. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS AND ORDERS; MILK), DEPARTMENT OF AGRICULTURE GENERAL PROVISIONS OF FEDERAL MILK MARKETING ORDERS Class Prices § 1000.53 Announcement of class prices... administrator for each Federal milk marketing order shall announce the following prices (as applicable to...

  1. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS AND ORDERS; MILK), DEPARTMENT OF AGRICULTURE GENERAL PROVISIONS OF FEDERAL MILK MARKETING ORDERS Class Prices § 1000.53 Announcement of class prices... administrator for each Federal milk marketing order shall announce the following prices (as applicable to...

  2. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Milk), DEPARTMENT OF AGRICULTURE GENERAL PROVISIONS OF FEDERAL MILK MARKETING ORDERS Class Prices § 1000.53 Announcement of class prices... administrator for each Federal milk marketing order shall announce the following prices (as applicable to...

  3. 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

  4. 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...

  5. 21 CFR 830.100 - FDA accreditation of an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100 Section 830.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... according to a single set of consistent, fair, and reasonable terms and conditions. (5) Will protect...

  6. FDA Bioinformatics Tool for Microbial Genomics Research on Molecular Characterization of Bacterial Foodborne Pathogens Using Microarrays

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background: Advances in microbial genomics and bioinformatics are offering greater insights into the emergence and spread of foodborne pathogens in outbreak scenarios. The Food and Drug Administration (FDA) has developed the genomics tool ArrayTrackTM, which provides extensive functionalities to man...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... employee of FDA may order the detention of any article of food that is found during an inspection... the article of food is adulterated or misbranded....

  8. 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...

  9. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical... comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug... http://www.regulations.gov . Submit written comments to the Division of Dockets Management...

  10. 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...

  11. 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...

  12. 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...

  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. 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

    • Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA

      MedlinePlus

      ... medlineplus.gov/news/fullstory_163464.html Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA Agency recommends getting ... by the human papillomavirus (HPV). An FDA-approved vaccine called Gardasil 9 protects against 9 HPV types ...

    • 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.

    • Integration of new technology into clinical practice after FDA approval.

      PubMed

      Govil, Ashul; Hao, Steven C

      2016-10-01

      Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

    • 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...

    • Agenda: EDRN FDA Education Workshop — EDRN Public Portal

      Cancer.gov

      The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.

    • 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

  1. 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

  2. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.

    PubMed

    O'Neill, R T; Temple, R

    2012-03-01

    At the request of the Food and Drug Administration (FDA) and with its funding, the Panel on the Handling of Missing Data in Clinical Trials was created by the National Research Council's Committee on National Statistics. This panel recently published a report(1) with recommendations that will be of use not only to the FDA but also to the entire clinical trial community so that the latter can take measures to improve the conduct and analysis of clinical trials.

  3. Regulatory Advocacy Update: ASPS Comments in Response to the FDA Draft Guidance Documents on Human Cell and Tissue Products.

    PubMed

    Rubin, J Peter; D'Amico, Richard A; Rodriguez, Ricardo; Coleman, Sydney R; Cederna, Paul; Glasberg, Scot; Neumeister, Michael; Song, David H; Butler, Charles; Hume, Keith M

    2017-02-09

    The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).

  4. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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 preclinical... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86...

  5. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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 preclinical... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86...

  6. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 preclinical... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86...

  7. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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 preclinical... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86...

  8. 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... 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...

  9. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  10. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  11. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  12. 76 FR 46819 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and...

  13. 77 FR 38303 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ...: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study: Effect of Promotional Offers in...

  14. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.

    PubMed

    Kesselheim, A S; Darrow, J J

    2015-01-01

    New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating "substantial evidence" of efficacy. However, a number of legislative and regulatory initiatives, the most recent being the breakthrough therapy designation created in 2012, give the FDA flexibility to approve drugs on the basis of less rigorous data in situations of greater clinical need. These expedited development and review pathways now contribute to a majority of all new drug approvals and have important benefits in encouraging efficient availability of transformative drugs. They also have a number of risks, including a heightened possibility that the drugs will be discovered to be ineffective or unsafe after widespread use, and confusion by patients and physicians over what it means for a product to be "FDA approved."

  15. 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.

  16. Large Eddy Simulation of FDA's Idealized Medical Device.

    PubMed

    Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H

    2013-12-01

    A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered.

  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

    • Announcements under the Renewable Fuel Standard Program

      EPA Pesticide Factsheets

      RFS program announcements are posted below by the calendar year in which the action was posted. Announcements will include rulemakings, responses to petitions, new pathway approvals, compliance deadlines, alternative plans, and among others.

    • Funding announcements from federal government, Gates Foundation.

      PubMed

      Garmaise, David

      2007-05-01

      In two separate announcements, in December 2006 and February 2007, the federal government allocated new funding for HIV/AIDS. The latter announcement was accompanied by a pledge from the Gates Foundation.

    • 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

  1. Fisher, Neyman, and Bayes at FDA.

    PubMed

    Rubin, Donald B

    2016-01-01

    The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

  2. 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

  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

    ... and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and other entities about how the FDA intends to apply its regulatory authorities to select...

  4. 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

    ... Technologists (IFT) report to FDA and the submission of information relevant to improving product tracing. The... comments on the findings and recommendations contained in the IFT report and the submission of information relevant to improving product tracing. Comments on the findings and recommendations contained in the...

  5. 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

  6. 76 FR 62455 - Announcement of Updated Funding Availability for H-1B Technical Skills Training Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... Employment and Training Administration Announcement of Updated Funding Availability for H-1B Technical Skills Training Grants AGENCY: Employment and Training Administration, Labor. ACTION: Notice of Additional Funding. SUMMARY: On May 3, 2011, the Employment and Training Administration (ETA) published a notice in...

  7. 78 FR 70248 - Medical Gas Regulation Review; Announcement of Public Meeting; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Medical Gas Regulation Review; Announcement of Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; correction. SUMMARY: The Food and Drug Administration is correcting a document that appeared...

  8. 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...: Denver Presley, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr.,...

  9. 76 FR 14405 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Focus Groups About Drug Products, as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  10. 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

  11. 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

  12. The FDA's new advice on fish: it's complicated.

    PubMed

    Wenstrom, Katharine D

    2014-11-01

    The Food and Drug Administration and Environmental Protection Agency recently issued an updated draft of advice on fish consumption for pregnant and breastfeeding women, after survey data indicated that the majority of pregnant women do not eat much fish and thus may have inadequate intake of the omega 3 fatty acids eicosapentaenoic acid [EPA] and ducosahexaenoic acid [DHA]. Omega 3 fatty acids are essential components of membranes in all cells of the body and are vitally important for normal development of the brain and retinal tissues (especially myelin and retinal photoreceptors) and for maintenance of normal neurotransmission and connectivity. They also serve as substrates for the synthesis of a variety of antiinflammatory and inflammation-resolving mediators, favorably alter the production of thromboxane and prostaglandin E2, and improve cardiovascular health by preventing fatal arrhythmias and reducing triglyceride and C-reactive protein levels. Maternal ingestion of adequate quantities of fish (defined in many studies as at least 340 g of oily fish each week) has been associated with better childhood IQ scores, fine motor coordination, and communication and social skills, along with other benefits. Although the FDA did not clarify which fish to eat, it specifically advised against eating fish with the highest mercury levels and implied that fish with high levels of EPA and DHA and low levels of mercury are ideal. The FDA draft did not recommend taking omega 3 fatty acid or fish oil supplements instead of eating fish, which is advice that may reflect the fact that randomized controlled trials of DHA and EPA or fish oil supplementation generally have been disappointing and that the ideal daily dose of DHA and EPA is unknown. It seems safe to conclude that pregnant and nursing women should be advised to eat fish to benefit from naturally occurring omega 3 fatty acids, to avoid fish with high levels of mercury and other contaminants, and, if possible, to choose

  13. Announcement

    NASA Astrophysics Data System (ADS)

    2008-01-01

    In order to keep abreast with the progress of physics in the 21st century, from 2008 the Chinese Physical Society will arrange all its physics journals published in English into a series, so as to present the publications in an orderly way. The Society has decided that from issue No 1 2008, Chinese Physics will change its title to Chinese Physics B and its website will be http://cpb.iphy.ac.cn to facilitate international academic exchanges. The journal's publication goals, policy and scope of distribution still remain unchanged, and its volume number will continue directly from Chinese Physics, i.e. the 2008 volume will be volume 17, so that the new name will not interrupt the continuity of the publication history of Chinese Physics. The rank of Chinese Physics B in the SCI database will not be affected and we have been assured by the Editorial Office of SCI (an e-mail reply dated 1 Feb. 2007 from the editor of SCI-E) that the change of name to Chinese Physics B will in no way affect our citation frequency and impact factor statistics. Chinese Physics B will still be published monthly on the 4th day of every month, in a large edition of 16mo with 250 pages in each issue. Similarly, it will be distributed domestically by the Editorial Office of Chinese Physics B, at a price of 86 Yuan RMB, while distributed abroad by the Institute of Physics Publishing, UK, at a price which will be given on the inside front cover of issue No 1 2008 of the journal. Fax: 010-82649072, Tel:010-82649026, 010-82649294

  14. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    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.

  15. 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

  16. 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...

  17. 77 FR 64809 - Announcement of the Award of a Single-Source Replacement Grant to the University of Colorado...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-23

    ... HUMAN SERVICES Administration for Children and Families Announcement of the Award of a Single-Source Replacement Grant to the University of Colorado Denver, Kempe Center for the Prevention and Treatment of Child Abuse & Neglect AGENCY: Children's Bureau, ACF, HHS. ACTION: Announcement of the award of a...

  18. 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. |

  19. Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

    PubMed

    Sage, Adam; Blalock, Susan J; Carpenter, Delesha

    This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications.

  20. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

    PubMed

    Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

  1. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

    PubMed

    Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry

    2014-10-01

    Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse.

  2. 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.

  3. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

    ... advisor at FDA. back to top Not Quite ‘Dairy Free’ In addition to these advisory statements, labels ... chocolate bars may make other claims. Some say “dairy-free” or “lactose free,” but FDA found milk ...

  4. 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

  5. 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.

  6. 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.

  7. 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

  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, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Los...

  9. 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, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Baltimore District Office,...

  10. 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...

  11. 76 FR 17656 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  12. 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....

  13. 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.

  14. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA...

  15. 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 the Award of Three Single-Source Program Expansion Supplement Grants to National Human Trafficking... . SUPPLEMENTARY INFORMATION: The National Human Trafficking Victim Assistance Program (NHTVAP) provides...

  16. CGH and OCC Announce a New, Two-Year Funding Opportunity for NCI-designated Cancer Centers

    Cancer.gov

    CGH and OCC announce a new funding opportunity available from CGH for cancer prevention and control (CPC) researchers at NCI-designated cancer centers: Administrative Supplements to Promote Cancer Prevention and Control Research in Low and Middle Income Countries.

  17. 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)

  18. FDA wants tighter rules for indoor tanning.

    PubMed

    2013-07-01

    Aiming to minimize skin cancer risk and other health drawbacks of tanning beds, the U.S. Food and Drug Administration proposed new rules to increase regulation of the devices and to require warning labels recommending increased screening for cancer.

  19. Import for export; reporting and recordkeeping requirements for unapproved or violative products imported for further processing or incorporation and subsequent export--FDA. Proposed rule.

    PubMed

    1998-11-24

    The Food and Drug Administration (FDA) is proposing reporting and recordkeeping regulations to implement certain sections of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the FDA Export Reform and Enhancement Act of 1996. The proposed rule would require an importer to report to FDA each time it imports an unapproved or otherwise violative article that is to be exported after further processing or incorporation into another product in the United States and to keep records to ensure that the article is so processed or incorporated and then exported, and that any portion of the import that is not exported is destroyed.

  20. 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.

  1. 47 CFR 73.4260 - Teaser announcements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 4 2011-10-01 2011-10-01 false Teaser announcements. 73.4260 Section 73.4260 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Rules Applicable to All Broadcast Stations § 73.4260 Teaser announcements. See Public Notice, FCC...

  2. 47 CFR 73.4260 - Teaser announcements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Teaser announcements. 73.4260 Section 73.4260 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Rules Applicable to All Broadcast Stations § 73.4260 Teaser announcements. See Public Notice, FCC...

  3. 10 CFR 603.410 - Announcement content.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Announcement content. 603.410 Section 603.410 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase § 603.410 Announcement content. Once the contracting officer, in consultation with the program official, considers the factors described in...

  4. 10 CFR 603.410 - Announcement content.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Announcement content. 603.410 Section 603.410 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase § 603.410 Announcement content. Once the contracting officer, in consultation with the program official, considers the factors described in...

  5. 10 CFR 603.410 - Announcement content.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Announcement content. 603.410 Section 603.410 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase § 603.410 Announcement content. Once the contracting officer, in consultation with the program official, considers the factors described in...

  6. 10 CFR 603.410 - Announcement content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Announcement content. 603.410 Section 603.410 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase § 603.410 Announcement content. Once the contracting officer, in consultation with the program official, considers the factors described in...

  7. 10 CFR 603.410 - Announcement content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Announcement content. 603.410 Section 603.410 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase § 603.410 Announcement content. Once the contracting officer, in consultation with the program official, considers the factors described in...

  8. A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

    PubMed

    Carpenter, Daniel

    2005-01-01

    I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augmentation is an achievable, incremental reform that would subsidize information that is now undersupplied in the U.S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system.

  9. 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.

  10. FDA regulation of dietary supplements and requirements regarding adverse event reporting.

    PubMed

    Frankos, V H; Street, D A; O'Neill, R K

    2010-02-01

    In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.

  11. Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature

    PubMed Central

    Beijers, Lian; Jeronimus, Bertus F; Turner, Erick H; de Jonge, Peter; Roest, Annelieke M

    2017-01-01

    Objectives This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. Methods For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as ‘non-FDA’ concerns. Findings Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Conclusions Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns. PMID:28360236

  12. Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

    PubMed Central

    Kim, Gilhyang; Chung, Yul Ri; Kim, Bohyun; Song, Boram; Moon, Kyung Chul

    2016-01-01

    Background Human epidermal growth factor receptor 2 (HER2) is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC) has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA) criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC) using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+) and high (2+, 3+) groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001). The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004), but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161) in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC. PMID:27725621

  13. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs.

    PubMed

    Ross, Joseph S; Dzara, Kristina; Downing, Nicholas S

    2015-04-01

    The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.

  14. FDA to Weigh Dangers of Exploding E-Cigarettes

    MedlinePlus

    ... FDA had identified 66 instances of e-cigarette explosions in 2015 and early 2016. The batteries overheated, ... that e-cigarettes pose no more fire or explosion risk than other devices that rely on lithium- ...

  15. FDA Encourages More Participation, Diversity in Clinical Trials

    MedlinePlus

    ... or older and people from certain racial and ethnic groups. That’s why the FDA is encouraging more ... clinical trials, especially people of different ages, races, ethnic groups, and genders. Read on to learn more ...

  16. FDA Approves New Treatment for Dust Mite Allergies

    MedlinePlus

    ... 163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra is a year-round treatment for ... 2017 (HealthDay News) -- A new treatment for dust mite allergies has won approval from the U.S. Food ...

  17. America's Porky Pets Face Health Woes, Too, FDA Says

    MedlinePlus

    ... Woes, Too, FDA Says More than half of dogs, cats in the Land of Plenty weigh too ... its pets, with a majority of cats and dogs dangerously overweight, a federal government veterinarian warns. "Just ...

  18. FDA Bacteriological Analytical Manual, Chapter 10, 2003: Listeria monocytogenes

    EPA Pesticide Factsheets

    FDA Bacteriological Analytical Manual, Chapter 10 describes procedures for analysis of food samples and may be adapted for assessment of solid, particulate, aerosol, liquid and water samples containing Listeria monocytogenes.

  19. FDA Throws Cold Water on Whole Body Cryotherapy

    MedlinePlus

    ... html FDA Throws Cold Water on Whole Body Cryotherapy Exposure to ultra-low temperatures shows no benefits ... evidence that a growing trend called whole body cryotherapy is effective, but it does pose a number ...

  20. 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...

  1. Obinutuzumab breaks through to FDA approval.

    PubMed

    2014-01-01

    The U.S. Food and Drug Administration approved the monoclonal antibody obinutuzumab for use with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The drug is the first to receive approval under the agency's breakthrough therapy designation, created in July 2012.

  2. 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

  3. Twitter sentiment around the Earnings Announcement events

    PubMed Central

    Grčar, Miha

    2017-01-01

    We investigate the relationship between social media, Twitter in particular, and stock market. We provide an in-depth analysis of the Twitter volume and sentiment about the 30 companies in the Dow Jones Industrial Average index, over a period of three years. We focus on Earnings Announcements and show that there is a considerable difference with respect to when the announcements are made: before the market opens or after the market closes. The two different timings of the Earnings Announcements were already investigated in the financial literature, but not yet in the social media. We analyze the differences in terms of the Twitter volumes, cumulative abnormal returns, trade returns, and earnings surprises. We report mixed results. On the one hand, we show that the Twitter sentiment (the collective opinion of the users) on the day of the announcement very well reflects the stock moves on the same day. We demonstrate this by applying the event study methodology, where the polarity of the Earnings Announcements is computed from the Twitter sentiment. Cumulative abnormal returns are high (2–4%) and statistically significant. On the other hand, we find only weak predictive power of the Twitter sentiment one day in advance. It turns out that it is important how to account for the announcements made after the market closes. These after-hours announcements draw high Twitter activity immediately, but volume and price changes in trading are observed only on the next day. On the day before the announcements, the Twitter volume is low, and the sentiment has very weak predictive power. A useful lesson learned is the importance of the proper alignment between the announcements, trading and Twitter data. PMID:28235103

  4. Twitter sentiment around the Earnings Announcement events.

    PubMed

    Gabrovšek, Peter; Aleksovski, Darko; Mozetič, Igor; Grčar, Miha

    2017-01-01

    We investigate the relationship between social media, Twitter in particular, and stock market. We provide an in-depth analysis of the Twitter volume and sentiment about the 30 companies in the Dow Jones Industrial Average index, over a period of three years. We focus on Earnings Announcements and show that there is a considerable difference with respect to when the announcements are made: before the market opens or after the market closes. The two different timings of the Earnings Announcements were already investigated in the financial literature, but not yet in the social media. We analyze the differences in terms of the Twitter volumes, cumulative abnormal returns, trade returns, and earnings surprises. We report mixed results. On the one hand, we show that the Twitter sentiment (the collective opinion of the users) on the day of the announcement very well reflects the stock moves on the same day. We demonstrate this by applying the event study methodology, where the polarity of the Earnings Announcements is computed from the Twitter sentiment. Cumulative abnormal returns are high (2-4%) and statistically significant. On the other hand, we find only weak predictive power of the Twitter sentiment one day in advance. It turns out that it is important how to account for the announcements made after the market closes. These after-hours announcements draw high Twitter activity immediately, but volume and price changes in trading are observed only on the next day. On the day before the announcements, the Twitter volume is low, and the sentiment has very weak predictive power. A useful lesson learned is the importance of the proper alignment between the announcements, trading and Twitter data.

  5. Subarray-based FDA radar to counteract deceptive ECM signals

    NASA Astrophysics Data System (ADS)

    Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

    2016-12-01

    In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

  6. The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

    PubMed

    Farris, April L

    2010-01-01

    As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

  7. 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.

  8. 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.

  9. 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.

  10. The impact of FDA guidance on pharmacogenomic data submissions on drug development.

    PubMed

    Little, Stephen

    2005-08-01

    After a long wait, the US Food and Drug Administration (FDA) finally released the much anticipated 'Guidance on Pharmacogenomic Data Submissions on Drug Development' in March 2005, but what impact will this have on the drug industry as a whole? It is becoming increasingly apparent that the field of pharmacogenomics can add value to both clinical trial design and the drug development process, but uptake by the pharmaceutical industry has so far been variable between companies. The opinion of the FDA is that the use of pharmacogenomics in drug development is a 'good thing' and one that it wishes to promote, hence, this new guidance is designed to assist drug companies to adopt pharmacogenomic technology in clinical development, and covers both targeted and exploratory aspects. While targeted pharmacogenomics must be included as part of any regulatory submission, exploratory approaches may be submitted voluntarily with assurances from the FDA that any such submissions will not be used to make regulatory decisions. With this regulatory framework now in place it is only a matter of time before it is known how the industry reacts and the impact it will have on drug development.

  11. 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!).

  12. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.

    PubMed

    2017-01-01

    Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients

  13. Rare cancer trial design: lessons from FDA approvals.

    PubMed

    Gaddipati, Himabindu; Liu, Ke; Pariser, Anne; Pazdur, Richard

    2012-10-01

    A systematic analysis of clinical trials supporting rare cancer drug approvals may identify concepts and terms that can inform the effective design of prospective clinical trials for rare cancers. In this article, using annual incidence ≤6 of 100,000 individuals to define "rare cancer," we identified clinical trials for rare cancers, supporting U.S. Food and Drug Administration (FDA) drug approvals for rare cancer indications between December 1987 and May 2011. We characterized each selected trial for study design, sample size, primary efficacy endpoints, and statistical comparisons. We also profiled trials with regard to type of submission, review designation, and approval type. Our results indicated that, of 99 trials that supported the approvals of 45 drugs for 68 rare cancer indications, one third of these trials were randomized; 69% of approvals relied on objective response rate as the primary efficacy endpoint; and 63% were based on a single trial. Drugs granted accelerated approval appeared more likely to be associated with postmarketing safety findings, relative to drugs approved under the regular approval. Data collected across clinical trials were robust: Use of different lower incidence rates in analyzing these trials did not have effects on trial characteristics. The absolute number of drug approvals for rare cancer indications increased markedly over time. We concluded that one third of clinical trials supporting drug approvals for rare cancer indications were randomized, affirming the feasibility and value of randomized trial design to evaluate drugs for rare cancers. Postmarketing safety data may relate to trial design and approval type. An operational definition of "rare cancer" can be useful for the analysis of trial data and for the path toward harmonizing the terminology in the area of clinical research on rare cancers.

  14. NASA's Kepler Mission Announces Latest Discoveries

    NASA Video Gallery

    Scientists from NASA's Kepler mission have been busy recently. The team has announced the discovery of Kepler-22b, its first confirmed planet in the habitable zone of its solar system, 600 light ye...

  15. Discovery announced of four new elements

    NASA Astrophysics Data System (ADS)

    Banks, Michael

    2016-02-01

    The International Union of Pure and Applied Chemistry (IUPAC) and the International Union of Pure and Applied Physics (IUPAP) have announced the discovery of four new elements: 113, 115, 117 and 118 - completing the periodic table's seventh row.

  16. NASA Announces CCiCap Partnerships

    NASA Video Gallery

    NASA and its Commercial Crew Program (CCP) announced new agreements today with three American commercial companies to design and develop the next generation of U.S. human spaceflight capabilities, ...

  17. EPA Announces Nutrient Recycling Challenge Winners

    EPA Pesticide Factsheets

    WASHINGTON - Today, the U.S. Environmental Protection Agency (EPA) announced the winners of Phase I of the Nutrient Recycling Challenge-a competition to develop affordable technologies to recycle nutrients from livestock manure. The winners received

  18. 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)...

  19. Clinicians' knowledge of 2007 Food and Drug Administration recommendation to discontinue nelfinavir use during pregnancy.

    PubMed

    Fogler, Jessica; Weber, Shannon; Mahoney, Megan R; Goldschmidt, Ronald H

    2009-01-01

    In 2007, the US Food and Drug Administration (FDA) and Pfizer Inc recommended immediate discontinuation of nelfinavir (NFV) during pregnancy due to contamination with a potential teratogen. A few weeks after the announcement, we surveyed antenatal HIV care providers to determine how widely the warning was disseminated. Overall, 69 of 121 (57.0%) providers knew to discontinue NFV. Callers with more than 50 HIV-infected patients were 2.54 times as likely to be aware as callers with 1-3 HIV-infected patients (P < .01). Only 12 (33.3%) obstetricians were aware, compared to 21 (80.8%) infectious diseases specialists (P < .001). The FDA/Pfizer Inc recommendation to avoid nelfinavir mesylate (NFV) in pregnancy appears to have successfully reached HIV experts. However, not all pregnant women have access to experts and may receive most of their care from providers without extensive HIV experience. More effective dissemination of critical HIV-related information to all antenatal care providers, including general obstetricians, family physicians, and midwives, may be needed.

  20. [How to announce the diagnosis for melanoma?].

    PubMed

    Charles, Cécile; Rouby, Pascal; Robert, Caroline

    2014-01-01

    Announcing a diagnosis of cutaneaous melanoma is a complex moment of medical activity and has some specificities due to the disease, but also to its management. After defining these aspects, the article deals with the principals steps and elements, including communicative ones, of this form of announcement. Its aim is above all practice: it is proposing some guidelines drawn from official recommendations and recent works on the physician-patient relationship in oncology, aiming at helping health professionals in this field.

  1. Administrative detention of drugs intended for human or animal use. Final rule.

    PubMed

    2014-05-29

    The Food and Drug Administration (FDA or the Agency) is implementing administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA's administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain. Specifically, FDA is able to administratively detain drugs encountered during an inspection that an authorized FDA representative conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.

  2. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  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. 47 CFR 11.46 - EAS public service announcements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false EAS public service announcements. 11.46 Section...) Organization § 11.46 EAS public service announcements. EAS Participants may use Public Service Announcements or obtain commercial sponsors for announcements, infomercials, or programs explaining the EAS to the......

  5. 47 CFR 11.46 - EAS public service announcements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false EAS public service announcements. 11.46 Section...) Organization § 11.46 EAS public service announcements. EAS Participants may use Public Service Announcements or obtain commercial sponsors for announcements, infomercials, or programs explaining the EAS to the......

  6. US FDA perspective on regulatory issues affecting circulatory assist devices.

    PubMed

    Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

    2006-11-01

    There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.

  7. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

  8. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

  9. Further amendments to general regulations of the Food and Drug Administration to incorporate tobacco products. Final rule.

    PubMed

    2012-02-02

    The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.

  10. 75 FR 82406 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

    ... 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 Office of Management and Budget Approval; Designated New Animal Drugs for Minor Use and Minor...

  11. 78 FR 68865 - Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... Employment and Training Administration Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in Alaska, Mississippi, and Wisconsin in the Emergency Unemployment Compensation..., 2013. Based on data from Alaska for the week ending August 3, 2013, the 13 week insured...

  12. 78 FR 59374 - Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-26

    ... Employment and Training Administration Announcement Regarding a Change in Eligibility for Unemployment Insurance (UI) Claimants in Alaska, Mississippi, and Wisconsin in the Emergency Unemployment Compensation..., 2013. Based on data from Alaska for the week ending August 3, 2013, the 13 week insured...

  13. 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

    ... of the Competition: In celebration of National Small Business Week 2012, the U.S. Small Business... From the Federal Register Online via the Government Publishing Office SMALL BUSINESS ADMINISTRATION Announcement of National Small Business Week Video Contest Under the America...

  14. 75 FR 82407 - 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 Office of Management and Budget Approval; Prior Notice of Imported Food Under the Public Health Security... information entitled ``Prior Notice of Imported Food Under the Public Health Security and...

  15. U.S. EPA to Announce Millions to Improve Local Water Infrastructure, Water Quality Statewide

    EPA Pesticide Factsheets

    LOS ANGELES - Tomorrow, U.S. EPA Regional Administrator Jared Blumenfeld will be joined by City of Carlsbad Mayor Matt Hall to announce millions of dollars in funding to the state that will improve local water infrastructure and control water pollution st

  16. 76 FR 14405 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... INFORMATION: In the Federal Register of January 12, 2011 (76 FR 2127), the Agency announced that the proposed..., Format, and Content of Petitions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions'' has been...

  17. The FDA proposed solar simulator versus sunlight.

    PubMed

    Sayre, Robert M; Dowdy, John C

    2010-04-01

    The US Food and Drug Administration is in the process of formulating final rules for sunscreen labeling and testing. They have adopted a version of the solar simulator standard proposed by COLIPA, a European cosmetic products trade association. From our files we have selected spectral data on several solar simulators that comply with the proposed rules and have compared these sources both one to another and to several standard solar spectra of Air Mass 1.0, 1.5, and 2.0. In doing so we have used additional spectral analysis procedures including examining the goodness of fit between each solar simulator spectrum and an Air Mass 1.0 (0 degrees zenith angle) solar spectrum. The index of goodness of fit ranges from approximately 78% to just over 90% compared to solar spectra representing other Air Masses of 1.5 and 2.0, the goodness of fit is lower. Unfortunately, one may not assume that complying with a standard assures that other solar simulators also complying will produce identical results. In fact, by our analysis, none of the solar simulators we examined would be expected to produce the same SPF as sunlight.

  18. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.

    PubMed

    Basile, Edward M; Tolomeo, Deborah; Gluck, Elizabeth

    2009-01-01

    With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems "adulterated," contrary to the plain language and legislative intent of the FDCA. To further exacerbate the issue, FDA has begun to implement these policies without the notice-and-comment rulemaking required by the Administrative Procedures Act (APA), but rather through an enforcement proceeding brought in the United States District Court for the District of New Jersey. In a letter opinion, the District Court prevented the export of Current Good Manufacturing Practices (CGMP) --adulterated medical devices that complied with FDCA Section 801(e)(1), at least as historically interpreted by FDA. The purpose of this article is to review the history of FDA's export policies for pharmaceuticals and medical devices, particularly those aspects of the export policies that are affected by FDA's recent change in position. Three changes in FDA's interpretation of the export provisions of the FDCA will be addressed: 1) unapproved devices that a manufacturer reasonably believes are eligible for Section 510(k) clearance may no longer be exported under Section 801(e) and now must be exported under Section 802, in substantial compliance with Current CGMP; 2) adulterated devices and misbranded drugs can only be exported if the foreign purchaser's specifications cause the product to be adulterated; and 3) an article may not be exported if a like article has ever been sold or offered for sale in domestic commerce. FDA's new interpretations of FDCA

  19. 16 CFR 1013.3 - Announcement of Commission meetings and changes after announcement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... this part. (b) The Agency shall announce each Commission meeting in the Public Calendar or Master Calendar at least one week (seven calendar days) before the meeting. The Agency shall concurrently submit... without seven calendar days advance public notice, the Office of the Secretary shall announce...

  20. 16 CFR 1013.3 - Announcement of Commission meetings and changes after announcement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... this part. (b) The Agency shall announce each Commission meeting in the Public Calendar or Master Calendar at least one week (seven calendar days) before the meeting. The Agency shall concurrently submit... without seven calendar days advance public notice, the Office of the Secretary shall announce...

  1. 77 FR 14809 - Agency Information Collection Activities: Proposed Collection; Comment Request; Biosimilars User...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities: Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an...

  2. 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…

  3. 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.

  4. Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

    PubMed Central

    Wagner, C; Zhao, P; Pan, Y; Hsu, V; Grillo, J; Huang, SM; Sinha, V

    2015-01-01

    The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions. PMID:26225246

  5. US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.

    PubMed

    Lathrop, Julia Tait; Jeffery, Douglas A; Shea, Yvonne R; Scholl, Peter F; Chan, Maria M

    2016-01-01

    Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic.

  6. 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.

  7. 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.

  8. 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

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 78 FR 55081 - Announcing the Award of a Single-Source Cooperative Agreement to the American Public Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... Children, Youth and Families (ACYF), Children's Bureau (CB), Division of Capacity Building announces the...-jurisdictional electronic system to improve administrative efficiency in the interstate process of the ICPC. The... Placement of Children (ICPC) electronic system to improve administrative efficiency in the...

  15. 78 FR 33099 - Announcement of Requirements and Registration for “Continuity of Care and Follow-Up App Challenge”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ... HUMAN SERVICES Substance Abuse and Mental Health Administration Announcement of Requirements and Registration for ``Continuity of Care and Follow-Up App Challenge'' AGENCY: Substance Abuse and Mental Health... of Challenge Competition The Substance Abuse and Mental Health Services Administration (SAMHSA),...

  16. 77 FR 61416 - Announcement of the Award of Single-Source Expansion Supplement Grants to Nine Personal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ... HUMAN SERVICES Administration for Children and Families Announcement of the Award of Single-Source... program outcomes for youth participants. SUMMARY: The Administration on Children, Youth and Families (ACYF... Grantee organization City State award amount Child & Family Resources, Inc Tucson AZ $171,981.00...

  17. 77 FR 61761 - Announcement of the Award of a Single-Source Grant to the Native American Fatherhood and Families...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

    ... HUMAN SERVICES Administration for Children and Families Announcement of the Award of a Single-Source... Responsible Fatherhood in Native American communities. SUMMARY: The Administration for Children and Families... conduct a national outreach campaign focused on promoting the importance of fatherhood in...

  18. 77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

    ... enter through Building 1. Contact Person: Martha Monser, Office of the Chief Scientist, Office of the... Washington, DC area), to find out further information regarding FDA advisory committee information. A notice in the Federal Register about last minute modifications that impact a previously announced...

  19. 77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative... announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative... Transparency Initiative. This report includes eight initiatives adopted by the Commissioner of Food and...

  20. 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.

  1. 45 CFR 614.5 - Public announcement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION GOVERNMENT IN THE SUNSHINE ACT REGULATIONS OF THE NATIONAL SCIENCE BOARD § 614.5 Public announcement. (a) Except as provided in paragraphs (c) and (d) of this section, the National Science Board will make a public...

  2. 45 CFR 614.5 - Public announcement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION GOVERNMENT IN THE SUNSHINE ACT REGULATIONS OF THE NATIONAL SCIENCE BOARD § 614.5 Public announcement. (a) Except as provided in paragraphs (c) and (d) of this section, the National Science Board will make a public...

  3. Predictors of Learning from Public Service Announcements.

    ERIC Educational Resources Information Center

    Sun, Hsiu-hui

    A study focused on predictors of people's learning from public service announcements (PSAs) seen on television. Telephone interviews were conducted with 480 adults randomly selected from residents in Dane County, Wisconsin, in October 1987. Typical demographic information was obtained: sex, age, income, occupation and education. Commercial slogans…

  4. 76 FR 16630 - Announcement of an Award

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    ... Assistant Secretary and Inter-Departmental Liaison for Early Childhood Development announces the award of a..., Senior Policy Advisor for Early Childhood Health and Development, Office of the Deputy Assistant Secretary and Inter-Departmental Liaison for Early Childhood Development, 901 D Street, SW., Washington,...

  5. 10 CFR 603.405 - Announcement format.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Announcement format. 603.405 Section 603.405 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase..., decides that a TIA is among the types of instruments that may be awarded, the additional...

  6. 10 CFR 603.405 - Announcement format.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Announcement format. 603.405 Section 603.405 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase..., decides that a TIA is among the types of instruments that may be awarded, the additional...

  7. 10 CFR 603.405 - Announcement format.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Announcement format. 603.405 Section 603.405 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase..., decides that a TIA is among the types of instruments that may be awarded, the additional...

  8. 10 CFR 603.405 - Announcement format.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Announcement format. 603.405 Section 603.405 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Competition Phase..., decides that a TIA is among the types of instruments that may be awarded, the additional...

  9. 45 CFR 614.5 - Public announcement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION GOVERNMENT IN THE SUNSHINE ACT REGULATIONS OF THE NATIONAL SCIENCE BOARD § 614.5 Public announcement. (a) Except as provided in paragraphs (c) and (d) of this section, the National Science Board will make a public...

  10. 45 CFR 614.5 - Public announcement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION GOVERNMENT IN THE SUNSHINE ACT REGULATIONS OF THE NATIONAL SCIENCE BOARD § 614.5 Public announcement. (a) Except as provided in paragraphs (c) and (d) of this section, the National Science Board will make a public...

  11. 45 CFR 614.5 - Public announcement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION GOVERNMENT IN THE SUNSHINE ACT REGULATIONS OF THE NATIONAL SCIENCE BOARD § 614.5 Public announcement. (a) Except as provided in paragraphs (c) and (d) of this section, the National Science Board will make a public...

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

    PubMed Central

    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

    2016-01-01

    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

  13. 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

  14. 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

  15. 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.

  16. Food and Drug Administration

    MedlinePlus

    ... Reportable Food Registry Report an Emergency Report Suspected Criminal Activity For Industry: Drugs and Therapeutic Biologics News & ... FDA Organization FDA Basics Advisory Committees International Programs Criminal Investigations Emergency Preparedness & Response Working at FDA Training/ ...

  17. 食品药物管理局( FDA

    Center for Drug Evaluation (CDER)

    ... 士应立即与医疗保健专业人员联络咨询。 接触铅会对中央神经系统、肾、和免疫 系统造成严重的 ... 下载并完成表格,然后经传真至 1-800-FDA-0178 提交。 ...

  18. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  19. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  20. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  1. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  2. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  3. 48 CFR 36.601-1 - Public announcement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Public announcement. 36... CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.601-1 Public announcement. The Government shall publicly announce all requirements for...

  4. 48 CFR 305.303 - Announcement of contract awards.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Announcement of contract awards. (a) Public announcement. The Contracting Officer shall report awards over $3.5... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Announcement of contract awards. 305.303 Section 305.303 Federal Acquisition Regulations System HEALTH AND HUMAN...

  5. 48 CFR 305.303 - Announcement of contract awards.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Announcement of contract awards. (a) Public Announcement. The Contracting Officer shall report awards over $3.5... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Announcement of contract awards. 305.303 Section 305.303 Federal Acquisition Regulations System HEALTH AND HUMAN...

  6. 48 CFR 36.601-1 - Public announcement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Public announcement. 36... CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.601-1 Public announcement. The Government shall publicly announce all requirements for...

  7. FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable?

    PubMed

    Graham, Garry G; Day, Richard O; Graudins, Andis; Mohamudally, Anthoulla

    2010-04-01

    Hepatotoxicity from paracetamol is of great concern because of the considerable number of patients who develop severe toxicity from this drug. A group of senior medical practitioners, academics and scientists were brought together on June 29 and 30, 2009 by the Food and Drug Administration of USA (FDA) with the aim of providing advice on how to limit the number of cases of hepatotoxicity due to paracetamol in USA. The most contentious recommendations were the reduction in the dose of paracetamol to 650 mg and the elimination of prescription combination products of paracetamol and opiates. The first recommendation indicates that many members of the committee consider, despite much evidence to the contrary, that therapeutic doses of paracetamol (up to 4 g daily) are associated with a significant incidence of hepatotoxicity. The second recommendation, if accepted by FDA, will require major changes in the therapeutic use of paracetamol and opiates. Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions.

  8. A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

    NASA Astrophysics Data System (ADS)

    Rogstad, Sarah; Faustino, Anneliese; Ruth, Ashley; Keire, David; Boyne, Michael; Park, Jun

    2016-11-01

    The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization. To further examine how MS is being used in successful BLAs, the applications were filtered based on the type and number of quality attributes characterized, the mass spectrometric workflows used (peptide mapping, intact mass analysis, and cleaved glycan analysis), the methods used to introduce the proteins into the gas phase (ESI, MALDI, or LC-ESI), and the specific types of instrumentation used. Analyses were conducted over a time course based on the FDA BLA approval to determine if any trends in utilization could be observed over time. Additionally, the different classes of protein-based biotherapeutics among the approved BLAs were clustered to determine if any trends could be attributed to the specific type of biotherapeutic.

  9. Generation of recombinant arenavirus for vaccine development in FDA-approved Vero cells.

    PubMed

    Cheng, Benson Y H; Ortiz-Riaño, Emilio; de la Torre, Juan Carlos; Martínez-Sobrido, Luis

    2013-08-01

    The development and implementation of arenavirus reverse genetics represents a significant breakthrough in the arenavirus field. The use of cell-based arenavirus minigenome systems together with the ability to generate recombinant infectious arenaviruses with predetermined mutations in their genomes has facilitated the investigation of the contribution of viral determinants to the different steps of the arenavirus life cycle, as well as virus-host interactions and mechanisms of arenavirus pathogenesis. In addition, the development of trisegmented arenaviruses has permitted the use of the arenavirus genome to express additional foreign genes of interest, thus opening the possibility of arenavirus-based vaccine vector applications. Likewise, the development of single-cycle infectious arenaviruses capable of expressing reporter genes provides a new experimental tool to improve the safety of research involving highly pathogenic human arenaviruses. The generation of recombinant arenaviruses using plasmid-based reverse genetics techniques has so far relied on the use of rodent cell lines, which poses some barriers for the development of Food and Drug Administration (FDA)-licensed vaccine or vaccine vectors. To overcome this obstacle, we describe here the efficient generation of recombinant arenaviruses in FDA-approved Vero cells.

  10. Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule.

    PubMed

    Bergman, Kimberly L; Krudys, K; Seo, S K; Florian, J

    2017-04-01

    Development of effective medical countermeasures for biodefense is vital to United States biopreparedness and response in the age of terrorism, both foreign and domestic. A traditional drug development pathway toward approval is not possible for most biodefense-related indications, creating the need for alternative development pathways such as the FDA's Animal Rule. Under this unique regulatory mechanism, FDA-approval is based on adequate and well-controlled animal studies when it is neither ethical nor feasible to conduct human efficacy studies. Translation of animal efficacy findings to humans is accomplished by use of modeling and simulation techniques. Pharmacokinetic and exposure-response modeling allow effective dosing regimens in humans to be identified, which are expected to produce similar benefit to that observed in animal models of disease. In this review, the role of modeling and simulation in determining the human dose for biodefense products developed under the Food and Drug Administration's Animal Rule regulatory pathway is discussed, and case studies illustrating the utility of modeling and simulation in this area of development are presented.

  11. Data mining of the public version of the FDA Adverse Event Reporting System.

    PubMed

    Sakaeda, Toshiyuki; Tamon, Akiko; Kadoyama, Kaori; Okuno, Yasushi

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

  12. FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials.

    PubMed

    Itani, Kamal M F; Shorr, Andrew F

    2014-01-01

    Recent guidance from the US Food and Drug Administration (FDA) on the conduct of clinical trials for acute bacterial skin and skin structure infection (ABSSSI) has changed the framework for clinical trial design and conduct. Notable changes included new disease state definitions, new primary endpoint definitions and the timing of assessments at these endpoints, and updated guidance on patient inclusion/exclusion criteria. Supportive evidence and statistical justification for the proposed noninferiority margins were described in detail. Although the updated guidelines are still considered drafts and have been adopted in some trials, they serve as the basis for study protocol discussions between pharmaceutical companies and the FDA in advancing the development of promising new agents. Not only will the new trial designs impact researchers and sponsors responsible for drug development programs, but they will also affect healthcare providers participating in clinical trials and the ways in which clinicians develop patient treatment plans based on the results of those trials. This review provides a summary of key changes that will impact future clinical trial design and outcomes.

  13. ISS-N1 makes the First FDA-approved Drug for Spinal Muscular Atrophy

    PubMed Central

    Ottesen, Eric W.

    2017-01-01

    Abstract Spinal muscular atrophy (SMA) is one of the leading genetic diseases of children and infants. SMA is caused by deletions or mutations of Survival Motor Neuron 1 (SMN1) gene. SMN2, a nearly identical copy of SMN1, cannot compensate for the loss of SMN1 due to predominant skipping of exon 7. While various regulatory elements that modulate SMN2 exon 7 splicing have been proposed, intronic splicing silencer N1 (ISS-N1) has emerged as the most promising target thus far for antisense oligonucleotide-mediated splicing correction in SMA. Upon procuring exclusive license from the University of Massachussets Medical School in 2010, Ionis Pharmaceuticals (formerly ISIS Pharamaceuticals) began clinical development of Spinraza™ (synonyms: Nusinersen, IONIS-SMNRX, ISIS-SMNRX), an antisense drug based on ISS-N1 target. Spinraza™ showed very promising results at all steps of the clinical development and was approved by US Food and Drug Administration (FDA) on December 23, 2016. Spinraza™ is the first FDA-approved treatment for SMA and the first antisense drug to restore expression of a fully functional protein via splicing correction. The success of Spinraza™ underscores the potential of intronic sequences as promising therapeutic targets and sets the stage for further improvement of antisense drugs based on advanced oligonucleotide chemistries and delivery protocols.

  14. FDA-approved neurologic devices intended for use in infants, children, and adolescents.

    PubMed

    Peña, Carlos; Bowsher, Kristen; Samuels-Reid, Joy

    2004-10-12

    The US Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n = 8) include indications for use in children as well as adults. On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in children. The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices. We review risk assessment and ways to reduce risk for neurologic devices intended for use in children. We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.

  15. USDA FSIS, FDA BAM, AOAC, and ISO culture methods BD BBL CHROMagar Listeria Media.

    PubMed

    Ritter, Vicki; Kircher, Susan; Sturm, Krista; Warns, Patty; Dick, Nancy

    2009-01-01

    BBL CHROMagar Listeria Media (CL) was evaluated for detection of Listeria monocytogenes in raw ground beef, smoked salmon, lettuce, and Brie cheese. The recovery of L. monocytogenes on CL was compared to the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM), U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), AOAC, and International Organization for Standardization (ISO) reference-plated media using the recommended pre-enrichments and selective enrichments. Of the 265 food samples tested, 140 were tested using BAM, USDA, or AOAC methods and 125 were tested using ISO methods. CL produced comparable results with the reference methods on all matrixes with a sensitivity of 99.3% and a specificity of 100%. No false negatives were found in testing the food matrixes. There was no statistical difference in recovery based on Chi-square analysis. Known isolates were evaluated, and CL had a sensitivity and specificity of 100%. The results of this study demonstrate that CL is an effective medium for the recovery and detection of L. monocytogenes in raw ground beef, smoked salmon, lettuce, and Brie cheese using FDA BAM, USDA FSIS, AOAC, and ISO culture methods.

  16. Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.

    PubMed

    Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini

    2009-01-01

    This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.

  17. 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

    ... and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency... announcing the availability of a report entitled ``Food and Drug Administration Report on Good Guidance... Office of the Commissioner prepared a report entitled ``Food and Drug Administration Report on...

  18. 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

    ... implement the principles of transparent, collaborative, and participatory government. The Open Government... intended to provide the public with basic information about FDA and how the agency does its work. This... conversations with FDA officials about the work of their Offices. Each month, senior officials from FDA...

  19. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

  20. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

  1. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1... General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or qualified employee of FDA may order the detention of any article of food that is found during an...

  3. 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... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

  4. Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012.

    PubMed

    Eshera, Noha; Itana, Hawi; Zhang, Lei; Soon, Greg; Fadiran, Emmanuel O

    2015-01-01

    To fully assess the safety and efficacy of therapeutics before approval, the US Food and Drug Administration (FDA) has encouraged adequate representation and assessment of demographic subgroups in clinical trials through guidance documents and regulations. This study aimed to survey the demographics of participants in pivotal clinical trials, as well as the presence of analyses by sex on efficacy and safety for FDA-approved new drug applications (NDAs) and biologics license applications (BLAs) from 2010 to 2012. Medical and statistical reviews for new molecular entity drugs and biological products approved during this period were obtained from Drugs@FDA. All pivotal clinical trials referenced in the FDA reviews were evaluated for the participation of different demographic subgroups (such as sex, race/ethnicity, and age). Pivotal trials were defined as those phase 2 and/or phase 3 trials described in the labeling or the FDA medical reviews in support of the drug/biological approval. Eighty-three new molecular entities (66 NDAs and 17 BLAs) were approved by the FDA from 2010 to 2012. Overall, women constituted 45% of trial participants for NDAs and 65% for BLAs. Sex analysis related to safety and efficacy was reported in 92% of the surveyed FDA medical and statistical reviews. Most NDAs and BLAs (82%) had a study population that was representative of the sex distribution for the intended patient population; however, most study participants were whites (77%), and minority racial/ethnic groups had lower participation rates in the study population than would be representative of the US racial group populations.

  5. NICBR Announces First Collaboration Project Awards | Poster

    Cancer.gov

    Courtesy of the NICBR Public Affairs/Community Relations Subcommittee The National Interagency Confederation for Biological Research (NICBR) announced the 2012 NICBR Collaboration Project Award (CPA) Program winners in December. The award, the first of its kind for NICBR, was adapted from the National Cancer Institute’s (NCI’s) Young Investigator Award Program. This year, the CPA was bestowed to three research projects pertaining to collaborations between NICBR agencies.

  6. Automated Announcements of Approaching Emergency Vehicles

    NASA Technical Reports Server (NTRS)

    Bachelder, Aaron; Foster, Conrad

    2006-01-01

    Street intersections that are equipped with traffic lights would also be equipped with means for generating audible announcements of approaching emergency vehicles, according to a proposal. The means to generate the announcements would be implemented in the intersection- based subsystems of emergency traffic-light-preemption systems like those described in the two immediately preceding articles and in "Systems Would Preempt Traffic Lights for Emergency Vehicles" (NPO-30573), NASA Tech Briefs, Vol. 28, No. 10 (October 2004), page 36. Preempting traffic lights is not, by itself, sufficient to warn pedestrians at affected intersections that emergency vehicles are approaching. Automated visual displays that warn of approaching emergency vehicles can be helpful as a supplement to preemption of traffic lights, but experience teaches that for a variety of reasons, pedestrians often do not see such displays. Moreover, in noisy and crowded urban settings, the lights and sirens on emergency vehicles are often not noticed until a few seconds before the vehicles arrive. According to the proposal, the traffic-light preemption subsystem at each intersection would generate an audible announcement for example, emergency vehicle approaching, please clear intersection whenever a preemption was triggered. The subsystem would estimate the time of arrival of an approaching emergency vehicle by use of vehicle identity, position, and time data from one or more sources that could include units connected to traffic loops and/or transponders connected to diagnostic and navigation systems in participating emergency vehicles. The intersection-based subsystem would then start the announcement far enough in advance to enable pedestrians to leave the roadway before any emergency vehicles arrive.

  7. FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?

    PubMed

    Corsetti, M; Tack, J

    2013-06-01

    Trial design and endpoints for the evaluation of drug efficacy in irritable bowel syndrome (IBS) underwent major changes over the last two decades. A systematic review in the early 1990s concluded that there were few well-designed and well-executed treatment trials in IBS. Over the next decade, the so-called binary endpoints were used in several clinical trials in IBS in the US, Europe and other parts of the world. In 2006, the Food and Drug Administration (FDA) published a general guidance for the evaluation of symptom benefit in clinical trials based on patient-reported outcome (PRO) measures, which had a major impact on trial design in IBS. In May 2012, the FDA recommended to use as provisional endpoint the quantification of two major IBS aspects, abdominal pain and disordered defecation, to assess the efficacy of pharmacological treatments in IBS. In the present issue of Neurogastroenterology & Motility, the performance of the FDA Responder Endpoint for clinical trials in irritable bowel syndrome with constipation was evaluated using data from two large Phase III clinical trials of linaclotide. The FDA interim endpoints are clinically relevant as they are also able to capture the smallest patient-reported difference in the domain of Abdominal Pain intensity and Abnormal Defecation with good diagnostic accuracy. The FDA responder definition and the European Medicines Agency responder definitions generate similar response rates, while binary endpoints generate higher responder rates. The implications for optimalization and harmonisation are discussed.

  8. 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.

  9. 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.

  10. An analysis of FDA-approved drugs for inflammation and autoimmune diseases.

    PubMed

    Kinch, Michael S; Merkel, Janie

    2015-08-01

    The term 'inflammation' captures a variety of disease processes linked with the immune system. An analysis of US Food and Drug Administration (FDA)-approved nuclear molecular entities (NMEs) reveals notable trends in terms of acute and chronic inflammatory indications. The number of NMEs peaked during the 1990s and has since declined by more than 50%. Whereas pharmaceutical companies have dominated the field, biotechnology companies now receive half of new approvals and academia has a relatively large role in terms of pivotal first patents. Another notable trend is that the relative number of NMEs targeting allergy has been decreasing, whereas those targeting autoimmune indications is increasing. Unlike other indications, NMEs for inflammation tend towards nuclear receptors and cytokines, and a disproportionate number of biologics target cytokine pathways.

  11. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.

    PubMed

    Dieterle, Frank; Sistare, Frank; Goodsaid, Federico; Papaluca, Marisa; Ozer, Josef S; Webb, Craig P; Baer, William; Senagore, Anthony; Schipper, Matthew J; Vonderscher, Jacky; Sultana, Stefan; Gerhold, David L; Phillips, Jonathan A; Maurer, Gérard; Carl, Kevin; Laurie, David; Harpur, Ernie; Sonee, Manisha; Ennulat, Daniela; Holder, Dan; Andrews-Cleavenger, Dina; Gu, Yi-Zhong; Thompson, Karol L; Goering, Peter L; Vidal, Jean-Marc; Abadie, Eric; Maciulaitis, Romaldas; Jacobson-Kram, David; Defelice, Albert F; Hausner, Elizabeth A; Blank, Melanie; Thompson, Aliza; Harlow, Patricia; Throckmorton, Douglas; Xiao, Shen; Xu, Nancy; Taylor, William; Vamvakas, Spiros; Flamion, Bruno; Lima, Beatriz Silva; Kasper, Peter; Pasanen, Markku; Prasad, Krishna; Troth, Sean; Bounous, Denise; Robinson-Gravatt, Denise; Betton, Graham; Davis, Myrtle A; Akunda, Jackie; McDuffie, James Eric; Suter, Laura; Obert, Leslie; Guffroy, Magalie; Pinches, Mark; Jayadev, Supriya; Blomme, Eric A; Beushausen, Sven A; Barlow, Valérie G; Collins, Nathaniel; Waring, Jeff; Honor, David; Snook, Sandra; Lee, Jinhe; Rossi, Phil; Walker, Elizabeth; Mattes, William

    2010-05-01

    The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have been qualified for limited use in nonclinical and clinical drug development to help guide safety assessments. This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.

  12. [Leaking: Frequency and correlates of announcements and threats of homicidal violence reported by Berlin schools between 1996 and 2007].

    PubMed

    Leuschner, Vincenz; Bondü, Rebecca; Allroggen, Marc; Scheithauer, Herbert

    2016-01-01

    Threats and announcements of homicidal violence at schools may have massive consequences like evacuations, police searches, criminal investigations, or loss of the sense of security by students, teachers, and parents. However, there is a lack of systematic studies about that phenomenon. The present article would like to contribute to closing the research gap. It presents results about the frequency and structure of threats and announcements of homicidal violence in schools in Berlin. The study is based on an official dataset from school administration reports of violent acts in Berlin schools which has been studied within the Berlin Leaking-Projekt. The sample consists of 427 threats and announcements of homicidal violence between 1996 and 2007. The study is an exceptional analysis of the phenomenon: it presents crosscutting results about frequency and characteristics of threats and the threatening students as well as results of a longitudinal analysis about the development of threats and announcements. Results show a rate of 0,3 threats and announcements per 1 000 student and year. During the observation time span a steady increase of threats and announcements – year by year, influenced by imitation effects after school shootings – has been observed.

  13. 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

  14. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    PubMed

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  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. 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.

  17. Automatic extraction of drug indications from FDA drug labels.

    PubMed

    Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong

    2014-01-01

    Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.

  18. 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.

  19. European Space Agency announces comet landing site

    NASA Astrophysics Data System (ADS)

    Wendel, JoAnna

    2014-09-01

    Scientists believe that comets hold clues to the solar system's origins, and soon they will be one step closer to unlocking these secrets. Last week, the European Space Agency announced that the spacecraft Rosetta will deploy its lander, Philae, to land on the "head" of the comet 67/P Churyumov-Gerasimenko at candidate site J. Project scientists have been racing to choose an ideal landing site since Rosetta arrived at the comet on 6 August. This event will mark the first landing mission on a comet.

  20. FDA review of viral load test kits. Food and Drug Administration.

    PubMed

    1996-03-01

    Viral load testing, which quantifies the amount of HIV in the blood plasma of infected individuals, may dramatically shorten the time necessary to test drugs prior to approval and marketing. Two manufacturers have applied for approval of their test kits. Hoffman-LaRoche (Roche Molecular Systems) developed a test kit called quantitative competitive polymerase chain reaction (quantitative PCR). Chiron Corporation's product is called branched chain DNA, or bDNA. Both tests give similar results. Viral load is an indicator of the effectiveness of drug therapy, and high viral load is an indicator of disease progression and clinical decline.