Science.gov

Sample records for administration fda announced

  1. 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

    ...In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing......

  2. Implementation of the mutual recognition agreement between the United States and the European Community; pharmaceutical GMP's and medical devices; establishment of a public docket and FDA contact points. Food and Drug Administration, HHS. Establishment of a public docket and FDA contact points.

    PubMed

    1999-03-01

    The Food and Drug Administration (FDA) is announcing the establishment of a public docket for the submission and public availability of information concerning the implementation of the Mutual Recognition Agreement (MRA) between the United States and the European Community (EC) in the areas of pharmaceutical good manufacturing practices (GMP's) and medical devices. FDA is also establishing contact points for information covering particular subjects under the MRA implementation, and the agency is making appropriate information available on the FDA web site. PMID:10557625

  3. 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.

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

    Cancer.gov

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

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

    PubMed

    Baker, R

    1995-09-01

    The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs. PMID:11362892

  6. 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....

  7. 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

    .... 02D-0049, now Docket No. FDA- 2002-D-0094, 67 FR 6545, February 12, 2002). The draft guidance was... comment (72 FR 61657, October 31, 2007). The Agency reviewed the submitted comments on the January 2002..., and increased the consistency and clarity of the process (73 FR 45459, August 5, 2008) (...

  8. Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.

    PubMed

    Smith, Jeffrey K

    2013-04-01

    Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database. PMID:23269527

  9. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric... Office of Orphan Product Development and will include participants from the FDA's Center for Devices...

  10. 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).

  11. 78 FR 48689 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug User Fee Cover Sheet; Form FDA 3397'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  12. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    PubMed Central

    2013-01-01

    Background The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration

  13. 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

    ... 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. 170.105 Section 170.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION...

  14. 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. PMID:26667601

  15. 29 CFR 775.1 - Advisory interpretations announced by the Administrator.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Advisory interpretations announced by the Administrator. 775.1 Section 775.1 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT... § 775.1 Advisory interpretations announced by the Administrator. Advisory interpretations announced...

  16. 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

    ... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled... 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....

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

    Code of Federal Regulations, 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....

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 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....

  20. Impact of the U.S. Food and Drug Administration's Safety-Related Announcements on the Use of Bisphosphonates After Hip Fracture.

    PubMed

    Kim, Seoyoung C; Kim, Dae Hyun; Mogun, Helen; Eddings, Wesley; Polinski, Jennifer M; Franklin, Jessica M; Solomon, Daniel H

    2016-08-01

    The U.S. Food and Drug Administration (FDA) issued several announcements related to potential risk of bisphosphonates including osteonecrosis of the jaw (2005), atrial fibrillation (2007), and atypical femur fracture (2010). We aimed to evaluate the impact of three FDA drug safety announcements on the use of bisphosphonates in patients with hip fracture using claims data from a U.S. commercial health plan (2004-2013). We calculated the proportion of patients in each quarter who received a bisphosphonate or other osteoporosis medication in the 6 months following hospitalization for hip fracture. Segmented logistic regression models examined the time trends. Among 22,598 patients with hip fracture, use of bisphosphonate decreased from 15% in 2004 to 3% in the last quarter of 2013. Prior to the 2007 announcement, there was a 4% increase in the odds of bisphosphonate use every quarter (OR 1.04; 95% CI, 1.02 to 1.07). After the 2007 announcement, there was a 4% decrease in the odds of bisphosphonate use (OR 0.96; 95% CI, 0.93 to 0.99) every quarter. The announcement in 2007 was associated with a significant decline in the rate of change of bisphosphonate uses over time (p < 0.001), but no impact on other osteoporosis medication use (p = 0.2). After the 2010 announcement, the odds of bisphosphonate use continued to decrease by 4% (OR 0.96; 95% CI, 0.94 to 0.98) each quarter and the odds of other osteoporosis medication use remained stable over time (OR 0.99; 95% CI, 0.96 to 1.02). The FDA safety announcement related to atrial fibrillation in 2007 was significantly associated with a decrease in bisphosphonate use among patients with hip fracture. © 2016 American Society for Bone and Mineral Research. PMID:26969902

  1. 7 CFR 1000.45 - 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... GENERAL PROVISIONS OF FEDERAL MILK MARKETING ORDERS Classification of Milk § 1000.45 Market administrator... corresponding step of § 1000.44(b), the market administrator shall estimate and publicly announce...

  2. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013.......

  3. FDA Boxed Warning for Immediate-Release Opioids.

    PubMed

    Food And Drug Administration Public Health Service U S Department Of Health And Human Services

    2016-06-01

    On March 22, 2016, the Food and Drug Administration (FDA) announced enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death. The new safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use. PMID:27301692

  4. 77 FR 41416 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ...The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global......

  5. 76 FR 56770 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

    ...The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This 2.5-day public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global......

  6. 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

  7. 78 FR 44574 - Third Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Third Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  8. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  9. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ... HUMAN SERVICES Food and Drug Administration Second Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  10. 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. PMID:26189046

  11. 78 FR 9703 - Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ...The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and......

  12. 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

  13. 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...

  14. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Drugs@FDA: FDA Approved Drug Products FDA Home Drug Databases Drugs@FDA - FAQ | Instructions | ... 6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency ...

  15. 75 FR 72827 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... Federal Register of June 24, 2010 (75 FR 36097), the agency announced that the proposed information... Office of Management and Budget Approval; Adoption of Food and Drug Administration Food Code by Local... Food and Drug Administration (FDA) is announcing that a collection of information entitled...

  16. 7 CFR 1001.45 - 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. 1001.45 Section 1001.45 Agriculture Regulations of the Department of Agriculture... MILK IN THE NORTHEAST MARKETING AREA Order Regulating Handling Classification of Milk § 1001.45...

  17. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical......

  18. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of......

  19. 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

    ... Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the Federal Register of January 30, 2013 (78 FR 6332... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration...

  20. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... In the February 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing... disclosure. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR...

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

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  2. 77 FR 15765 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ...The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 028'' (Recognition List Number: 028), will assist manufacturers who......

  3. 75 FR 82406 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

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

  4. 76 FR 14404 - 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...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792,...

  5. 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…

  6. 75 FR 70679 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-18

    ... proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  7. 77 FR 45621 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

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

  8. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

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

  9. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

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

  12. 76 FR 74790 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

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

  13. 78 FR 48691 - Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ...The Food and Drug Administration (FDA) is announcing a meeting for patients, caregivers, patient advocates, as well as patient advocate and health professional groups, to provide a primer on drug product development and explore patient involvement in drug development. The meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals,......

  14. 78 FR 13072 - Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA Statistics Forum--2013.'' The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for......

  15. 76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,'' dated June 2011. The guidance document provides advice to potential......

  16. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include......

  17. FDA Approves New Drug for Chronic Lymphocytic Leukemia in Patients with a Specific Chromosomal Abnormality

    MedlinePlus

    ... Newsroom Press Announcements FDA News Release FDA approves new drug for chronic lymphocytic leukemia in patients with ... of leukemia in adults, with approximately 15,000 new cases diagnosed each year. CLL is characterized by ...

  18. 78 FR 20666 - Food and Drug Administration/National Institutes of Health/National Science Foundation Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

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

  19. 78 FR 17611 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... these new sections. On November 23, 2012 (77 FR 70166), FDA issued a Federal Register notice... FR 74852), FDA issued a notice of availability announcing publication of a draft guidance for... Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding...

  20. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed......

  1. 75 FR 6209 - Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.'' This guidance summarizes FDA's current thoughts on the appropriate use of Bayesian statistical methods in the design and analysis of medical device clinical...

  2. 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...

  3. 76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of supplemental grant funds...

  4. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... 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 entitled...

  5. 77 FR 42500 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

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

  6. 78 FR 27404 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-10

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  7. 76 FR 66072 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

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

  8. 78 FR 26783 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

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

  9. 77 FR 42502 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ...The Food and Drug Administration (FDA) is announcing that a collection of information entitled Survey of ``Health Care Providers' Responses to Medical Device Labeling'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of...

  10. 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...

  11. 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…

  12. FDA Modernizes Nutrition Facts Label for Packaged Foods

    MedlinePlus

    ... Department of Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health ... Release FDA modernizes Nutrition Facts label for packaged foods Refreshed design and relevant information will help consumers ...

  13. 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…

  14. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  15. 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...

  16. 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...

  17. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... 159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing eliminates need to take ... U.S. Food and Drug Administration. "Opioid abuse and addiction have taken a devastating toll on American families. ...

  18. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice.... In the Federal Register of July 21, 2011 (76 FR 43689), FDA announced the availability of the...

  19. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA- 2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III--A...

  20. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives...

  1. Is It Really FDA Approved?

    MedlinePlus

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

  2. 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 ...

  3. FDA 101: Dietary Supplements

    MedlinePlus

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

  4. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati... 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...

  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. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... conference will be held on the campus of Xavier University, 3800 Victory Pkwy., ] Cincinnati, OH 45207, 513... 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...

  7. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH... 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...

  8. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design... study design principles relevant to the development of medical device clinical studies that can be...

  9. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

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

  10. 7 CFR 1000.45 - Market administrator's reports and announcements concerning classification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... utilization (to the nearest whole percentage) in Class I during the month of skim milk and butterfat... data and shall be final for such purpose. (b) The market administrator shall report to the market... utilization are received, the class to which receipts from plants regulated under other Federal orders...

  11. Medical devices; refurbishers, rebuilders, reconditioners, servicers, and "as is" remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information--FDA. Advance notice of proposed rulemaking.

    PubMed

    1997-12-23

    The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters. PMID:10179309

  12. Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA. PMID:10128335

  13. 76 FR 66073 - Guidance for Industry on What You Need to Know About Administrative Detention of Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on What You Need to Know About.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... part 1, subpart K (21 CFR part 1, subpart K), (76 FR 25538), that pertain to the criteria for...

  14. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

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

  15. 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

  16. 78 FR 15953 - Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... HUMAN SERVICES Food and Drug Administration Cooperative Agreement To Support Regulatory Research Related...) announces its intention to accept and consider a single source application for award of a cooperative... accomplishment of these PDUFA V commitments. FDA is therefore seeking to establish a cooperative agreement...

  17. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

  18. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed......

  19. 78 FR 57320 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern,......

  20. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 314.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... application needed to facilitate the agency's review. This early communication is intended to...

  1. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 314.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... process. Such communication may take the form of telephone conversations, letters, or meetings,...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

  3. 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. PMID:26027494

  4. NCI Director Also to Be Interim FDA Commissioner

    Cancer.gov

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

  5. FDA OKs Non-Prescription Use of Acne Drug

    MedlinePlus

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

  6. FDA Calls for Less Salt in Processed Foods

    MedlinePlus

    ... html FDA Calls for Less Salt in Processed Foods Agency sets short- and long-term goals in ... WEDNESDAY, June 1, 2016 (HealthDay News) -- The U.S. Food and Drug Administration wants the food industry to ...

  7. Epidural steroid warning controversy still dogging FDA.

    PubMed

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

    2014-01-01

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

  8. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the requirement of special controls for class II......

  9. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to...

  10. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

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

  11. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft guidance provides information on how a manufacturer may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. In this......

  12. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

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

  13. 78 FR 47712 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-06

    ... of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled... meter. 13-59 Systems and software engineering--Systems and ISO/IEC 15026-4 First edition software... HUMAN SERVICES Food and Drug Administration (formerly 2004N-0226) Food and Drug...

  14. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

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

  15. Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice.

    PubMed

    1993-06-01

    The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document. PMID:10171452

  16. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... reporting requirements on FDA recalls. DATES: Submit either electronic or written comments on the collection... techniques, when appropriate, and other forms of information technology. FDA Recall Regulations--21 CFR...

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

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

  18. 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... announcing that a collection of information entitled ``Medical Device User Fee Cover Sheet, Form FDA 3601... collection of information entitled ``Medical Device User Fee Cover Sheet, Form FDA 3601'' to OMB for...

  19. 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…

  20. FDA-Approved HIV Medicines

    MedlinePlus

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

  1. Leavitt: reforms will improve oversight and openness at FDA.

    PubMed

    2005-01-01

    Health and Human Services Secretary Mike Leavitt says drug safety reforms at the Food and Drug Administration will improve openness and oversight and will enhance the agency's independence. In keeping with this vision, the FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues and will provide emerging information to doctors and patients about the risks and benefits of medicines. For more information www.fda.gov/cder/drugsafety.htm PMID:16127819

  2. 76 FR 67192 - Administration on Children, Youth and Families Announces the Award of a Single-Source Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... HUMAN SERVICES Administration for Children and Families Administration on Children, Youth and Families... Switchboard (NRS) in Chicago, IL AGENCY: Family and Youth Services Bureau, ACYF, ACF, HHS. ACTION: Notice of... the ``Reconnecting Homeless Youth Act of 2008,'' Public Law 110-378. CFDA Number: 93.623. SUMMARY:...

  3. 76 FR 67192 - Administration on Children, Youth and Families Announces the Award of Five Single-Source...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... HUMAN SERVICES Administration for Children and Families Administration on Children, Youth and Families... Assistance Activities in the Field of Child Welfare AGENCY: Children's Bureau, ACYF, ACF, HHS. ACTION: Notice... as they seek to implement legislation and changing programs that support children and families in...

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

    PubMed Central

    Bond, Katherine C.; Maher, Carmen

    2014-01-01

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

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

    PubMed

    2016-06-23

    The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS. PMID:27373012

  6. FDA-Approved Biosimilar Insulin

    PubMed Central

    2014-01-01

    If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient’s home. Adulterated products could be considered “counterfeit” since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes. PMID:25172881

  7. 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. PMID:19999639

  8. 21 CFR 530.24 - Procedure for announcing analytical methods for drug residue quantification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. FDA perspectives on health claims for food labels.

    PubMed

    Rowlands, J Craig; Hoadley, James E

    2006-04-01

    The U.S. Food and Drug Administration's regulatory authority over health claims was clarified in 1990 legislation known as the Nutrition Labeling and Education Act (NLEA). This law established mandatory nutrition labeling for most foods and placed restrictions on the use of food label claims characterizing the levels or health benefits of nutrients in foods. NLEA set a high threshold for the scientific standard under which the U.S. Food and Drug Administration (FDA) may authorize health claims, this standard is known as the significant scientific agreement (SSA) standard. Subsequent legislation known as the Food and Drug Administration Modernization Act (FDAMA) provided an alternative to FDA review of the health claim where an U.S. government scientific body other than FDA concluded that there is SSA for a substance/disease relationship. Courts have since extended the scope of health claims to include qualified health claims (QHC) that are health claims not substantiated on evidence that meets the level of SSA standard, but include a qualifying statement intended to convey to the consumer the level of evidence for the claim. FDA has responded by developing an evidence-based ranking system for scientific data to determine the level of evidence substantiating a health claim. The following is an overview of FDA's regulations and evidence-based method for evaluating health claims. PMID:16480811

  10. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... (76 FR 45820), FDA published a notice establishing fee rates for FY 2012 for domestic and foreign... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  11. 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...

  12. 14 CFR § 1260.8 - Announcements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  13. 14 CFR 1260.8 - Announcements.

    Code of Federal Regulations, 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...

  14. 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...

  15. 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...

  16. 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 Community Services, ACF, HHS. ACTION: Announcement of the Award of an Assets for Independence Grant to the... Demonstration Programs announces the award of an Assets for Independence (AFI) demonstration grant to the...

  17. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

  18. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

  19. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  1. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:...

  2. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:...

  3. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  4. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  5. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 316.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of... written notice recognizing exclusive approval once the marketing application for a designated...

  7. FDA Approves New Weight-Loss Device

    MedlinePlus

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

  8. FDA Warns About Stem Cell Claims

    MedlinePlus

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

  9. 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)...

  10. A tale of two transparency attempts at FDA.

    PubMed

    Tai, Laurence

    2013-01-01

    This Article describes and evaluates two elements of the FDA's recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency's FOIA backlog. After discussing the legal context for information disclosure at the FDA and these two transparency attempts, this Article identifies two reasons that the first has fallen short of expectations compared to the second: unlike the reduction in the FOIA backlog, the Transparency Initiative had legal constraints that it did not adequately address, along with political appointee leadership. These principles may be more generally useful for understanding how to stimulate institutional change in administrative agencies. PMID:24552081

  11. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

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

  12. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

    PubMed

    Zimmerman, Mark

    2016-06-01

    According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. PMID:27251690

  13. 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…

  14. 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. PMID:23063664

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

    PubMed

    Kay, G

    2001-01-01

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

  16. 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. PMID:20603657

  17. 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.

  18. FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk

    MedlinePlus

    ... nih.gov/medlineplus/news/fullstory_158144.html FDA: 2 Diabetes Drugs May Be Linked to Heart Failure ... Food and Drug Administration said. People with type 2 diabetes who use these drugs should not stop ...

  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

    ... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

  20. Young LGBT Adults Are Target of FDA Stop-Smoking Campaign

    MedlinePlus

    ... Young LGBT Adults Are Target of FDA Stop-Smoking Campaign Tobacco use is common among these 18- ... and Drug Administration has launched an LGBT stop-smoking campaign. "We know LGBT young adults in this ...

  1. 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

  2. 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

  3. News & Announcements

    NASA Astrophysics Data System (ADS)

    2001-06-01

    You are invited to send contributions to the JCE Announcements column. They should be sent to Elizabeth A. Moore, Associate Editor, by email at betmoore@chem.wisc.edu. Contributions should be concise, to the point, and appropriate for the Journal's audience. They may be edited for clarity, timeliness, appropriateness, or length.

  4. Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-11-22

    The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications." Elsewhere in this issue of the Federal Register. FDA is announcing the availability of this guidance document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices. PMID:11503713

  5. 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)

  6. 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. |

  7. 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]. PMID:22481744

  8. 22 CFR 708.4 - Public announcement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 2 2013-04-01 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...

  9. 22 CFR 708.4 - Public announcement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 2 2014-04-01 2014-04-01 false 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...

  10. 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...

  11. 22 CFR 708.4 - Public announcement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 2 2012-04-01 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

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

    PubMed

    2016-04-01

    The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations. PMID:27044118

  18. News & Announcements

    NASA Astrophysics Data System (ADS)

    2001-09-01

    Helge H. Wehmeier, President and Chief Executive Office of Bayer Corporation, is the recipient of the 2001 Leadership in Education Award from the Keystone Center. Wehmeier was cited for his support in spearheading ongoing education and volunteer efforts such as Bayer's Making Science Make Sense program, which, in partnership with NSF, advances science literacy through hands-on, inquiry-based science learning.

    You are invited to send contributions to the News & Announcements column. They should be sent to Elizabeth A. Moore, Associate Editor, by email or by mail at Journal of Chemical Education, 209 N. Brooks St., Madison, WI 53715-1116. Contributions should be concise, to the point, and appropriate for the Journal's audience. They may be edited for clarity, timeliness, appropriateness, or length.

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

    PubMed

    Waxman, Henry A

    2004-01-01

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

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

    PubMed

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

    2015-01-01

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

  1. 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... Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for...

  2. 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…

  3. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... gov/medlineplus/news/fullstory_159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing ... 26, 2016 (HealthDay News) -- A new long-acting implant that can help treat people addicted to heroin ...

  4. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... medlineplus/news/fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to ... 2016 THURSDAY, June 30, 2016 (HealthDay News) -- An implant that helps the aging eye focus on small ...

  5. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

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

  6. Traumatic Brain Injury: FDA Research and Actions

    MedlinePlus

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

  7. 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®)

  8. FDA Launches Ad Campaign Against Chewing Tobacco

    MedlinePlus

    ... 158385.html FDA Launches Ad Campaign Against Chewing Tobacco Health officials targeting rural teens with messages about health risks of smokeless tobacco products To use the sharing features on this ...

  9. FDA Approves First Fully Dissolvable Stent

    MedlinePlus

    ... fullstory_159721.html FDA Approves First Fully Dissolvable Stent Device is absorbed by the body after about ... July 5, 2016 (HealthDay News) -- The first coronary stent to be gradually absorbed by the body has ...

  10. FDA Bolsters Warnings about Class of Antibiotics

    MedlinePlus

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

  11. FDA Expands Advice on Statin Risks

    MedlinePlus

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

  12. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    PubMed

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. PMID:20575403

  13. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  14. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  15. News & Announcements

    NASA Astrophysics Data System (ADS)

    2000-01-01

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

    Awards Announced

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

  16. 48 CFR 1835.016-71 - NASA Research Announcements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  17. 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 Community Services, ACF, HHS. ACTION: Announcement of the Award of an Assets for Independence Grant to the... Demonstration Programs announces the award of an Assets for Independence (AFI) demonstration grant to the...

  18. 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

    ... Manager and Address FDA Research Integrity Officer, Office of the Chief Scientist, Food and Drug... 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...

  19. 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

  20. 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.

  1. Revisiting Financial Conflicts of Interest in FDA Advisory Committees

    PubMed Central

    Pham-Kanter, Genevieve

    2014-01-01

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

  2. FDA panel finds mifepristone safe and effective.

    PubMed

    1996-07-26

    At a July 19 hearing, the Food and Drug Administration's Advisory Committee for Reproductive Health Drugs found mifepristone to be safe and effective in inducing abortions early in pregnancy and recommended that the drug be approved for marketing in the US. With a 6-0 vote with two abstentions, the eight-member panel found that mifepristone's benefits were greater than its risks; agreed, 7-0, with one abstention, that it is safe; voted 6-2 to accept data from a French study as sufficient to recommend use in this country; and decided unanimously to reconvene if results from US clinical trials differ significantly from those from France. While the FDA is not required to follow the panel's advice, it is highly uncommon for it to do otherwise. The advisory panel scheduled the hearing in response to an application filed this spring by the Population Council, the nonprofit organization that owns the US patent rights to the drug. The meeting began with a presentation by the Population Council on the results of an American mifepristone trial that involved more than 2000 women and a discussion of the data from studies and practical use in France. The second session brought public testimony from 33 speakers, the majority of whom spoke in favor of the drug's approval. A company plans to manufacture mifepristone once it is approved but refuses to reveal its identity out of concern that it will be a target for anti-choice protests and boycotts. The drug would be marketed by Advances in Health Technology, Inc., an enterprise designated by the Population Council as the exclusive US distributor of mifepristone--the abortifacient marketed as RU486 in France and used by nearly 200,000 women in Europe and elsewhere. PMID:12347288

  3. 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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Turkoski, Beatrice B

    2016-01-01

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

  6. 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? 1.378 Section 1.378 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...

  7. 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...

  8. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  9. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Will FDA assign me a registration number? 1271.27 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...

  10. 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 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...

  11. 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...

  12. 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

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

      NASA Astrophysics Data System (ADS)

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

      2003-06-01

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

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

      PubMed

      Fishbane, Steven; Jhaveri, Kenar D

      2012-05-01

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

    • 2015 in review: FDA approval of new drugs.

      PubMed

      Kinch, Michael S

      2016-07-01

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

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

      PubMed Central

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

      2016-01-01

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

    • Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?

      PubMed

      Kelley, Peter

      2010-01-01

      It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

    • 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

      • 77 FR 23485 - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug...

        Federal Register 2010, 2011, 2012, 2013, 2014

        2012-04-19

        ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Patient Network Annual Meeting..., Steve.Morin@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. FDA Patient Network This is the inaugural FDA Patient Network Annual Meeting hosted by the FDA Office of Special Health Issues, the Agency's liaison...

      • 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. 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

  2. FDA aprueba la primera inmunoterapia para linfoma

    Cancer.gov

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

  3. 10 CFR 903.11 - Advance announcement of rate adjustment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Power and Transmission Rate Adjustments and Extensions for the Alaska, Southeastern, Southwestern, and Western Area Power Administrations § 903.11 Advance announcement of rate adjustment. The Administrator may... 10 Energy 4 2010-01-01 2010-01-01 false Advance announcement of rate adjustment. 903.11...

  4. 5 CFR 1632.6 - Public announcement of meetings.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 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, 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...

  6. 5 CFR 1632.6 - Public announcement of meetings.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 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...

  7. 5 CFR 1632.6 - Public announcement of meetings.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 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...

  8. 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...

  9. 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

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

    PubMed

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. PMID:27068243

  11. Antidepressants and Suicide Risk: How Did Specific Information in FDA Safety Warnings Affect Treatment Patterns?

    PubMed Central

    Busch, Susan H.; Frank, Richard G.; Leslie, Doug; Martin, Andres; Martin, Erika; Rosenheck, Robert; Barry, Colleen L.

    2009-01-01

    Objective From June 2003 through October 2004, the Food and Drug Administration (FDA) released five safety warnings related to antidepressant use and increased suicide risk in children. While researchers have documented a decline in antidepressant use in children over this time period, less is known about whether specific safety information conveyed in individual warnings was reflected in treatment patterns. Methods Thomson Marketscan claims data (2001–2005) for a national sample of privately insured children were used to construct treatment episodes (N=23,529). For each new episode of major depressive disorder, it was determined whether children’s treatment followed specific recommendations included in warnings released by the FDA. Treatment recommendations pertained to the use of the antidepressants paroxetine and fluoxetine and to patient monitoring. Treatment patterns were expected to change as the nature of risk information conveyed by the FDA changed over time. Results The timing of FDA recommendations was associated with trends in the use of paroxetine and fluoxetine by children with major depressive disorder newly initiating antidepressant treatment. However, no evidence of increases in outpatient visits (i.e., monitoring) among depressed children initiating antidepressants was found. Conclusions Release of specific risk and benefit information by the FDA was associated with changes in prescribing, but not outpatient follow-up. These results suggest the FDA plays an important role in communicating information to the public and providers, but while public health safety warnings were associated with changes in some practice patterns, not all recommendations conveyed in warnings were followed. PMID:20044412

  12. 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

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

  13. 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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2015-03-01

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

  16. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

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

  17. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... response to a request for input from FDA on this topic in March 2010 (75 FR 11893, March 12, 2010... Policy, Planning, and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 4226...'' and directing the Director of the Office of Management and Budget (OMB) to issue an Open...

  18. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How does FDA define the terms used in this part? 803.3 Section 803.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as amended. Ambulatory surgical facility...

  19. 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...

  20. 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...

  1. 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...

  2. 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

    ... the document at http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/Running... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and...

  3. FDA Recommends All Blood Donations Be Tested for Zika

    MedlinePlus

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

  4. 76 FR 34085 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    ... the Federal Register of December 15, 2010 (75 FR 78252), the Agency announced that the proposed... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Boards AGENCY: Food and...

  5. 75 FR 39953 - Modification to the Basic Center Program Funding Opportunity Announcement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... HUMAN SERVICES Administration for Children and Families Modification to the Basic Center Program Funding... Services Bureau. Funding Opportunity Title: Basic Center Program. Announcement Type: Modification. Funding.... This is a Modification to the Basic Center Program Funding Opportunity Announcement (FOA),...

  6. Possible FDA-approved drugs to treat Ebola virus infection.

    PubMed

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally, the estrogen receptor modulators Clomiphene and Toremifene prevent membrane fusion of EBOV and 50-90% of treated mice survived after Clomiphene/Toremifene treatments. However, the uptake efficiency of Clomiphene by oral administration is very low. Thus, I propose a hypothetical treatment protocol to treat Ebola virus infection with a cumulative use of both Miglustat and Toremifene to inhibit the virus effectively and synergistically. EBOV infection induces massive apoptosis of peripheral lymphocytes. Also, cytolysis of endothelial cells triggers disseminated intravascular coagulation (DIC) and subsequent multiple organ failures. Therefore, blood transfusions and active treatments with FDA-approved drugs to treat DIC are also recommended. PMID:25984303

  7. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... 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...

  8. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  9. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

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

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

    Cancer.gov

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

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

    PubMed

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

    2012-01-01

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

  12. 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." PMID:25670381

  13. The FDA's proposal for public disclosure of adverse events in gene therapy trials.

    PubMed

    Barnbaum, D R

    2000-09-01

    In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials. PMID:15468489

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

    PubMed

    Rose, Brenda

    2016-06-01

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

  15. 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. PMID:24187599

  16. 77 FR 55845 - Science Board to the Food and Drug Administration: Request for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration: Request... Administration (FDA) is requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to... given first consideration for membership on the Science Board. Nominations received after October...

  17. 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

  18. FDA Approval Summary: Ramucirumab for Gastric Cancer.

    PubMed

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

    2015-08-01

    The FDA approved ramucirumab (CYRAMZA; Eli Lilly and Company) for previously treated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma initially as monotherapy (April 21, 2014) and subsequently as combination therapy with paclitaxel (November 5, 2014). In the monotherapy trial, 355 patients in the indicated population were randomly allocated (2:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks. In the combination trial, 665 patients were randomly allocated (1:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks, in combination with paclitaxel, 80 mg/m(2) on days 1, 8, and 15 of 28-day cycles. Overall survival (OS) was increased in patients who received ramucirumab in both the monotherapy [HR, 0.78; 95% confidence interval (CI), 0.60-0.998; log rank P = 0.047] and combination trials (HR, 0.81; 95% CI, 0.68-0.96; P = 0.017). The most common adverse reactions were hypertension and diarrhea in the monotherapy trial and fatigue, neutropenia, diarrhea, and epistaxis in the combination trial. Because of concerns about the robustness of the monotherapy trial results, FDA approved the original application after receiving the results of the combination trial confirming the OS effect. Based on exploratory exposure-response analyses, there is residual uncertainty regarding the optimal dose of ramucirumab. PMID:26048277

  19. 76 FR 2123 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ....Gittleson@FDA.HHS.GOV . SUPPLEMENTARY INFORMATION: In the Federal Register of October 18, 2010 (75 FR 63834... Office of Management and Budget Approval; Current Good Manufacturing Practice Quality System Regulation...) is announcing that a collection of information entitled ``Current Good Manufacturing Practice...

  20. 75 FR 66104 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-27

    ....Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of June 15, 2010 (75 FR 33811... Office of Management and Budget Approval; The Mammography Quality Standards Act Requirements AGENCY: Food... announcing that a collection of information entitled ``The Mammography Quality Standards Act...

  1. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... higher brain areas such as the visual cortex or the lateral geniculate nucleus. In the Federal Register of April 17, 2009 (74 FR 17872), FDA announced the availability of the draft guidance. Comments...

  2. US FDA oncology drug approvals in 2014.

    PubMed

    Wolford, Juliet E; Tewari, Krishnansu S

    2015-01-01

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

  3. Target selection for FDA-approved medicines.

    PubMed

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

    2015-07-01

    The biopharmaceutical industry translates fundamental understanding of disease into new medicines. As part of a comprehensive analysis of FDA-approved new molecular entities (NMEs), we assessed the mechanistic basis of drug efficacy, with emphasis on target selection. Three target families capture almost half of all NMEs and the leading ten families capture more than three-quarters of NME approvals. Target families were related to their clinical application and identify dynamic trends in targeting over time. These data suggest increasing attention toward novel target families, which presumably reflects increased understanding of disease etiology. We also suggest the need to balance the ongoing emphasis on target-based drug discovery with phenotypic approaches to drug discovery. PMID:25462532

  4. 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

  5. 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

  6. 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

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

    Code of Federal Regulations, 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  11. 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. PMID:26556207

  12. 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

  13. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This... and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval...

  14. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced the...-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-12623, appearing on page 30175, in the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and...

  16. 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. PMID:25288421

  17. FDA's requirements for in-vivo performance data for prosthetic heart valves.

    PubMed

    Johnson, D M; Sapirstein, W

    1994-07-01

    The Food and Drug Administration (FDA) has recently revised its "Replacement Heart Valve Guidance". That document lists the data FDA deems necessary to support the approval of new prosthetic heart valves of all designs, and which should be contained in Premarket Approval Applications for these devices. The guidance covers detailed data requirements for in vitro, animal, and clinical data. This paper is intended to briefly summarize FDA's requirements for in vivo and clinical data. The clinical study must establish that the device is both safe and effective, as compared to currently marketed replacement heart valves. It is possible to achieve this goal using hypothesis testing to compare the results of an observational study against a set of Objective Performance Criteria (OPC) which have been established by the FDA. The establishment of the OPCs was facilitated by a standardized set of definitions of complications published by the American Association of Thoracic Surgery and Society of Thoracic Surgeons (AATS/STS) in 1987/1988. Papers published in peer reviewed journals have utilized this set of definitions for data analysis, providing an ample pool of data from which to establish OPCs. The number of patients required to establish the safety and efficacy of a replacement heart valve, using this approach, is 800 valve years, 400 in the aortic and 400 in the mitral position. Advantages of this approach are reduction in the number of patients and duration of the study. PMID:7952304

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

    PubMed

    Bradford, W David; Kleit, Andrew N

    2015-07-01

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

  19. FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

    PubMed

    Drum, Bruce

    2004-01-01

    The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device. PMID:15518230

  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. PMID:25840884

  1. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational... the device as a factor in making Medicare coverage decisions. ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices....

  2. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  3. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

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

  4. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

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

  5. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

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

  7. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

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

  8. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

  9. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

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

  10. 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

  11. FDA moves to permit oral contraceptive prescriptions without initial pelvic exam.

    PubMed

    1993-05-28

    The Planned Parenthood Federation of America (PPFA) submitted recommendations to the US Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee. The PPFA wanted the FDA to remove requirements for a pelvic examination and blood tests before an oral contraceptive (OC) is prescribed. Two representatives of the Family Planning Council of Southeastern Pennsylvania told the FDA advisory committee about the evaluation results of its Smart Start program. 23% of teenagers wanting to use OCs opted to delay the pelvic examination, and 40% opted to delay the blood tests. 83% of these same teenagers were already sexually active. 69% returned for pelvic exams at 3 months. Increased education and counseling over several sessions probably explained why more study participants used condoms and fewer of them became pregnant during the 6-month study. Physicians from the American College of Obstetricians and Gynecologists and the American Fertility Society also attended the committee hearing and supported PPFA's recommendations. The National Women's Health Network wanted to delay the discussion until the committee could also address the sale of OCs over-the-counter. The statements convinced the committee to allow physicians to defer to full physical examination as long as there are no contraindications. This May 20, 1993 approval emphasized the need for physicians to continue taking a complete medical history and conducting other tests that may uncover contraindications (e.g. pregnancy and blood pressure). FDA staff now must write the exact language needed for the OC labeling change to be approved by the FDA commissioner. PMID:12286460

  12. 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. PMID:25489841

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

    PubMed

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

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

  14. Hospital Providers: The Day After FDA Approval

    PubMed Central

    DeKoven, Mitchell; McCagh, Brian; Zoch, Jeremy

    2005-01-01

    Hospitals have a lot at stake when new biologic drugs and devices hit the market. Cooperation among medical and administrative leaders can help providers avoid some harrowing financial pitfalls – while improving patient satisfaction. PMID:23393477

  15. 76 FR 30368 - Announcement of the Publication of Funding Opportunity Announcements under the Runaway and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... Opportunity Announcements under the Runaway and Homeless Youth Act AGENCY: Family and Youth Services Bureau (FYSB), Administration on Children, Youth and Families (ACYF), ACF, HHS. ACTION: Funding Opportunity... application. CFDA Number: 93.623, 93.557. Statutory Authority: Runaway and Homeless Youth Act (Pub. L....

  16. 77 FR 33223 - Announcement of the Publication of Funding Opportunity Announcements Under the Runaway and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... Opportunity Announcements Under the Runaway and Homeless Youth Act AGENCY: Family and Youth Services Bureau (FYSB), Administration on Children, Youth and Families (ACYF), ACF, HHS. ACTION: Funding Opportunity... Homeless Youth Act, 42 U.S.C. sections 5701-5752, as amended by the Reconnecting Homeless Youth Act of...

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

    PubMed

    Shirlow, Esme; Faunce, Thomas

    2009-05-01

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

  18. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.

    PubMed

    Alder, H C

    1993-10-01

    The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the

  19. 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...

  20. 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....

  1. 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

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates 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...

  2. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

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

  3. Food and Drug Administration

    MedlinePlus

    ... safety rule implementation September 02, 2016 - FDA allows marketing of clot retrieval devices to reduce disability in ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...

  4. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

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

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

    PubMed

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

    2010-08-01

    ArrayTrack is a Food and Drug Administration (FDA) bioinformatics tool that has been widely adopted by the research community for genomics studies. It provides an integrated environment for microarray data management, analysis and interpretation. Most of its functionality for statistical, pathway and gene ontology analysis can also be applied independently to data generated by other molecular technologies. ArrayTrack has been undergoing active development and enhancement since its inception in 2001. This review summarises its key functionalities, with emphasis on the most recent extensions in support of the evolving needs of FDA's research programmes. ArrayTrack has added capability to manage, analyse and interpret proteomics and metabolomics data after quantification of peptides and metabolites abundance, respectively. Annotation information about single nucleotide polymorphisms and quantitative trait loci has been integrated to support genetics-related studies. Other extensions have been added to manage and analyse genomics data related to bacterial food-borne pathogens. PMID:20846933

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

    PubMed

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

    2007-01-01

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

  7. 76 FR 16630 - Announcement of an Award

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    ...The Administration for Children and Families (ACF), Office of the Deputy Assistant Secretary and Inter-Departmental Liaison for Early Childhood Development announces the award of a cooperative agreement with the Congressional Hunger Center (CHC) in Washington, DC, to work with ACF programs on hunger and obesity issues for young children. An award in the amount of $3,000 has been made to the......

  8. 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...

  9. FDA cautions against ultrasounds 'keepsake' images.

    PubMed

    Rados, Carol

    2004-01-01

    It's risky business taking pictures of unborn babies when there's no medical need to do so. That's the word from the Food and Drug Administration, which is concerned about companies trying to turn an important medical procedure into a prenatal portrait tool. PMID:15032198

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

    MedlinePlus

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

  11. FDA Approves Experimental Zika Test for Blood Donations

    MedlinePlus

    ... html FDA Approves Experimental Zika Test for Blood Donations But agency still asks those who've possibly ... HealthDay News) -- An experimental test to check blood donations for the Zika virus has been approved by ...

  12. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

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

  13. Expediting drug development--the FDA's new "breakthrough therapy" designation.

    PubMed

    Sherman, Rachel E; Li, Jun; Shapley, Stephanie; Robb, Melissa; Woodcock, Janet

    2013-11-14

    The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies. PMID:24224621

  14. FDA Calls for Less Salt in Processed Foods

    MedlinePlus

    ... news/fullstory_159136.html FDA Calls for Less Salt in Processed Foods Agency sets short- and long- ... the food industry to cut back on the salt. In draft voluntary guidelines issued Wednesday, the agency ...

  15. Drug for Yeast Infections May Raise Miscarriage Risk, FDA Warns

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158503.html Drug for Yeast Infections May Raise Miscarriage Risk, FDA Warns Agency recommends ... brand name Diflucan) is used to treat vaginal yeast infections. "Patients who are pregnant or actively trying to ...

  16. FDA Approves New Drug to Treat Bladder Cancer

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158937.html FDA Approves New Drug to Treat Bladder Cancer Tecentriq boosted survival ... 2016 THURSDAY, May 19, 2016 (HealthDay News) -- A new drug to treat bladder cancer was approved by ...

  17. Think Twice Before You Get That Tattoo: FDA

    MedlinePlus

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

  18. FDA to Re-Examine What Makes a Food 'Healthy'

    MedlinePlus

    ... should be labeled "healthy"? Raisin bran? Avocados? Granola bars? Going by current -- and perhaps outdated -- U.S. food- ... healthy" is Kind LLC, a producer of granola bars, which was warned by the FDA last year ...

  19. 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

    ... From the Federal Register Online via the Government Publishing Office SMALL BUSINESS ADMINISTRATION Announcement of National Small Business Week Video Contest Under the America Competes Reauthorization Act of 2011 AGENCY: Small Business Administration (SBA). ACTION: Notice. SUMMARY: In...

  20. Effect of the FDA on health care investments

    NASA Astrophysics Data System (ADS)

    Cleary, David J.

    1994-12-01

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

  1. FDA's regulation of tanning beds: how much heat?

    PubMed

    Knapp, Veronica

    2011-01-01

    This paper considers the problem of indoor tanning bed use by teenagers. The paper explores FDA's current authority to regulate tanning lamps as Class I medical devices, concluding that FDA's authority is poorly tailored to affect teenagers' repeated use of these products. An outright ban is unlikely; therefore, the best available options are to regulate access by minors and to amend the warning label requirements to reflect the current state of knowledge about the risks of tanning bed use. PMID:24505845

  2. Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned.

    PubMed

    Mathis, L L; Iyasu, S

    2007-08-01

    The Best Pharmaceuticals for Children Act (BPCA) was signed into law on 4 January 2002, shortly after the pediatric exclusivity provision of the Food and Drug Administration (FDA) Modernization Act expired on 1 January 2002. This Act provides six months of marketing exclusivity for a drug when a pharmaceutical company studies that drug for use in the pediatric population as requested by the FDA. Section 17 of the BPCA specifically requires that the FDA review all adverse events reported for drugs that receive pediatric exclusivity. In most of the cases, no unexpected adverse events were reported in the pediatric population; however, in some cases, this focused safety review provided information important to the safety of medication use in children. PMID:17632537

  3. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all......

  4. 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.

  5. 76 FR 43688 - Announcement of Expansion Supplement Grant Awards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ...The Administration for Children and Families (ACF), Administration for Native Americans (ANA), announces the award of ten expansion supplement awards to Native American Tribes that are currently combating the epidemic of health issues in Native America. Expansion supplement funds will support activities associated with the First Lady's initiative, Let's Move! in Indian Country. Under the......

  6. 75 FR 11610 - Notice Announcing Addresses for Service of Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

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

  7. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  8. The crime of saving lives. The FDA, John Najarian, and Minnesota ALG.

    PubMed

    Wilson, L G

    1995-10-01

    The indictment of John Najarian, MD, and Richard Condie at Minneapolis, Minn, on April 10, 1995, was a defining episode in the prolonged agony that has ensued since August 1992, when the federal Food and Drug Administration (FDA) placed Minnesota Anti-Lymphocyte Globulin (MALG) on clinical hold, bringing to an end its use as an immunosuppressive agent for patients undergoing transplantation. The principal charge in the indictment is that from about 1968 until 1992--the whole period of the development and use of MALG--Dr Najarian and Mr Condie conspired to defraud the United States by impeding the FDA in its oversight of biological drugs and that they did so for the purpose of financial gain. If the charges can be considered seriously, they mean that Dr Najarian's purpose in the development and manufacture of MALG was to make money, presumably for himself, and that the possible benefit of MALG to the patients was of secondary concern to him. Several difficulties arise immediately. In 1968, MALG offered a promising new approach to immunosuppression. In a relatively crude form, it had been used at the University of Colorado with striking improvement in the survival of patients undergoing transplantation and transplanted organs, but it was painful to administer by intramuscular injections and, in addition to other side effects, produced muscular spasms. Dr Najarian and his colleagues succeeded in purifying MALG so that the pure globulin could be injected into a central vein. The process of purification was complicated and expensive, so it was hardly practical for each transplant center to produce MALG for itself. Thus, in 1969, when Dr Najarian submitted an investigational new drug application (IND) to the FDA, he stated that his purpose was to manufacture MALG not only for patients at the University of Minnesota Hospital but also for patients at other transplant centers, which were not in a position to make it for themselves. He asked the FDA to approve recovery of

  9. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Food and Drug Administration Web site at http://www.fda.gov once finalized. (c) Agreements and... understandings will not be made available through the FDA Web site, these agreements will be available...

  10. 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.

  11. Review of non-FDA-approved fillers.

    PubMed

    Ellis, David A F; Segall, Lorne

    2007-05-01

    The number of commercially available injectable soft tissue fillers has increased dramatically worldwide over the past decade. In the United States, a variety of temporary non-collagen-based fillers have been approved. However, no permanent soft tissue injectable fillers are currently approved by the US Food and Drug Administration. This article discusses some of the more popular soft tissue fillers, such as Restylane Fine Line, Restylane SQ, Perlane, Artecoll, Dermalive, Dermadeep, Bioalcamid, Bioplastique, Evolution, Outline, Argiform, and Aquamid, which are all available outside of the United States. PMID:17544940

  12. 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. PMID:24475548

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2016-05-01

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

  15. 75 FR 29561 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ...The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product...

  16. FDA advisory committees meet January 26 on Salk HIV-1 immunogen.

    PubMed

    1995-01-01

    Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment. PMID:11362184

  17. 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.

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

    PubMed

    Campbell, Gregory; Yue, Lilly Q

    2016-01-01

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

  19. 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.

  20. Solyndra Loan Guarantee Announcement

    ScienceCinema

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

    2010-09-01

    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.

  1. 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.

  2. US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.

    PubMed

    Beitzel, Knut; Allen, Donald; Apostolakos, John; Russell, Ryan P; McCarthy, Mary Beth; Gallo, Gregory J; Cote, Mark P; Mazzocca, Augustus D

    2015-02-01

    With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market. The 510(k) application allows devices that are "substantially equivalent" to a currently marketed device to come to the market. There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered "off label." Clinicians are free to use a product off-label as long as certain responsibilities are met. Per CBER, when the intent is the practice of medicine, clinicians "have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent concern over activated PRP; however to date, the FDA has not attempted to regulate activated PRP. Clinicians using activated PRP should be mindful of these concerns and continued to stay informed. PMID

  3. FDA Orders Warning Labels on Prescription Narcotic Painkillers

    MedlinePlus

    ... Prevention announced tough new guidelines to doctors for "opioid" drugs such as Oxycontin, Percocet and Vicodin. "We ... death." A new prescribing guideline that immediate-release opioids "should be reserved for pain severe enough to ...

  4. 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

  5. Interactive perspective: drug development and FDA approval, 1938-2013.

    PubMed

    2015-02-01

    Interactive Perspective: Drug Development and FDA Approval, 1938-2013 (June 26, 2014;370:e39). The order of authors was incorrect; Dr. Darrow should have been listed first, and Dr. Kesselheim second. The article is correct at NEJM.org. PMID:25651270

  6. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health...

  7. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health...

  8. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... resources. Information on FDA closures and restrictions will be available for inspection at the park visitor... 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...

  9. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... resources. Information on FDA closures and restrictions will be available for inspection at the park visitor... 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. FDA OKs New Injectable Type 2 Diabetes Medication

    MedlinePlus

    ... shouldn't be used to treat people with type 1 diabetes. It also shouldn't be used by anyone with increased ketones (a sign that the body isn't getting enough insulin) in their blood or urine, or extremely elevated ketones (diabetic ketoacidosis), the FDA said. Common side effects of ...

  11. FDA post-approval expectations for adventitious virus contamination prevention.

    PubMed

    Friedman, Richard L

    2011-01-01

    CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA). PMID:22294604

  12. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  13. 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...

  14. 75 FR 76009 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    ...: In the Federal Register of May 13, 2010 (75 FR 26964), the agency announced that the proposed... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Products--General Requirements AGENCY: Food and...

  15. 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...

  16. 76 FR 32215 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... Federal Register of January 31, 2011 (76 FR 5384), the Agency announced that the proposed information... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Small Chains Under Section 4205 of the Patient Protection and Affordable Care Act of 2010 AGENCY:...

  17. 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...

  18. 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...

  19. 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)...

  20. 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...

  1. 76 FR 368 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

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

  2. 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... public observation pursuant to the provisions of § 2413.4(a), shall be made at the earliest...

  3. 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....

  4. 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....

  5. 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....

  6. 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...

  7. 76 FR 6798 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... . SUPPLEMENTARY INFORMATION: In the Federal Register of February 24, 2009 (74 FR 8264), the Agency announced that... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug...

  8. 76 FR 4917 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ... the Federal Register of August 6, 2010 (75 FR 47600), the Agency announced that the proposed... 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...

  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. PMID:24719072

  10. 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

  11. 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

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

    PubMed

    Brandt, Lawrence J

    2008-05-01

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

  13. 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. PMID:26292476

  14. 76 FR 67195 - Announcement of a Single-Source Grant Award to the National Association of Councils on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... HUMAN SERVICES Administration for Children and Families Announcement of a Single-Source Grant Award to...: Administration on Developmental Disabilities, ACF, HHS. ACTION: Announcement of a Single-Source Grant Award to... the award of a single-source grant of $620,000 to the National Association of Councils...

  15. 76 FR 41267 - Memorandum of Understanding Between the Food and Drug Administration and MEDSCAPE, LLC and WEBMD LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

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

  16. 78 FR 42099 - Announcement of Requirements and Registration for the “Stay Covered Challenge” and the “Churn...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... HUMAN SERVICES Substance Abuse and Mental Health Services Administration Announcement of Requirements... Development Challenge'' Authority: 15 U.S.C. 3719. AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. SUMMARY: The Substance Abuse and Mental Health Services...

  17. 46 CFR 503.82 - Public announcement of agency meeting.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 9 2012-10-01 2012-10-01 false Public announcement of agency meeting. 503.82 Section 503.82 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE PROVISIONS PUBLIC INFORMATION Public Observation of Federal Maritime Commission Meetings and Public Access to Information Pertaining...

  18. 46 CFR 503.82 - Public announcement of agency meeting.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 9 2014-10-01 2014-10-01 false Public announcement of agency meeting. 503.82 Section 503.82 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE PROVISIONS PUBLIC INFORMATION Public Observation of Federal Maritime Commission Meetings and Public Access to Information Pertaining...

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

    PubMed

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

    2016-06-01

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

  20. 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

  1. 76 FR 31964 - Announcement of the Award of Nine Single-Source Expansion Supplement Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... Resettlement. BILLING CODE 4184-01-P ... HUMAN SERVICES Administration for Children and Families Announcement of the Award of Nine Single-Source... award of nine single-source expansion supplement grants to the Voluntary Agencies Matching Grant...

  2. 77 FR 47080 - Announcement of Requirements and Registration for “Stop Bullying Video Challenge”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... mental health, substance use, and suicide. The Federal Partners for Bullying Prevention is a Federal... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Announcement of Requirements...

  3. 78 FR 22553 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... 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; Pretesting of Tobacco Communications AGENCY: Food and...

  4. 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

  5. Pictorial Health Warnings on Cigarette Packs in the United States: An Experimental Evaluation of the Proposed FDA Warnings

    PubMed Central

    Reid, Jessica L.; Driezen, Pete; Boudreau, Christian

    2013-01-01

    Introduction: In 2010, the U.S. Food and Drug Administration (FDA) developed 36 proposed health warnings for cigarette packages, from which 9 were subsequently selected for implementation. The current study aimed to evaluate the perceived efficacy of the 36 proposed FDA warnings. Methods: Web-based surveys were conducted with 783 adult smokers and 510 youth in United States. Participants were randomized to view and rate two sets of 6–7 warnings, each set corresponding to one of nine health effect statements required under the Tobacco Control Act. Warnings included all 36 FDA-proposed warnings and additional warnings for comparison. Results: Youth and adults rated individual warnings similarly; in all cases where differences were found, youth perceived warnings as more effective. Comparisons on specific elements indicated that warnings were perceived as more effective if they were: full color (vs. black and white), featured real people (vs. comic book style), contained graphic images (vs. nongraphic), and included a telephone “quitline” number or personal information. Few sociodemographic differences were observed in overall perceived effectiveness: younger respondents, non-White respondents, and smokers intending to quit rated warnings higher. Conclusions: Seven of the nine health warnings selected by the FDA for implementation were among the proposed warnings rated as most effective in the current study. However, the warning(s) added for comparison were rated higher than the FDA-selected warning for five of the nine sets, suggesting some warnings could be improved for greater impact. The findings support the inclusion of a telephone “quitline” number and reinforce the importance of depicting “real” people and health effects. PMID:22505660

  6. FDA changes clozapine monitoring guidelines: Implications for worldwide practice.

    PubMed

    Bastiampillai, Tarun; Gupta, Arun; Allison, Stephen

    2016-06-01

    US FDA decision to change their clozapine monitoring guidelines in 2015 for the first time. The changes proposed are as follows: lowering the neutrophil count before ceasing clozapine from 1.5 to 1.0×10(9)/l, allowing the potential for re-challenge following severe neutropenia (<1.0×10(9)/l) and allowing those with benign ethnic neutropenia the opportunity to be commenced on clozapine. These changes will allow a greater number of patients with schizophrenia in USA to be continued on clozapine. In our correspondence we summarize the evidence that support these changes. The FDA changes will likely have impact on clozapine monitoring protocols in other countries. PMID:27208449

  7. 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…

  8. QSAR Models at the US FDA/NCTR.

    PubMed

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

    2016-01-01

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

  9. 21 CFR 830.100 - FDA accreditation of an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... according to a single set of consistent, fair, and reasonable terms and conditions. (5) Will protect...

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

    MedlinePlus

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

  11. 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. PMID:26553791

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

    PubMed Central

    2014-01-01

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

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

    PubMed

    Do, Kathy T; Galván, Adriana

    2015-11-01

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

  14. 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. PMID:20213329

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

    PubMed

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

    2014-05-01

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

  16. Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells

    PubMed Central

    de la Torre, Juan Carlos; Martínez-Sobrido, Luis

    2013-01-01

    The development and implementation of arenavirus reverse genetics represents a significant breakthrough in the arenavirus field 4. 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 1, 3, 11 . 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 5 . 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 16 . The generation of recombinant arenaviruses using plasmid-based reverse genetics techniques has so far relied on the use of rodent cell lines 7,19 , 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. PMID:23928556

  17. 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. PMID:23794943

  18. FDA's recommendations on the use of long-acting {beta}2 agonists in the management of asthma.

    PubMed

    Robinson, Christie A

    2010-10-01

    The revised labeling for long-acting β(2) agonists (LABAs) by the Food and Drug Administration (FDA) is controversial and in part is inconsistent with the 2007 National Asthma Education and Prevention Program asthma guidelines. Two large randomized controlled studies, the Serevent Nationwide Surveillance (SNS) study and the Salmeterol Multicenter Asthma Research Trial (SMART), and a 2008 meta-analysis conducted by the FDA were the main sources of information used to determine the label changes. A paucity of large, well-designed, controlled, prospective studies evaluating the asthma-related risks associated with LABAs makes it difficult to reach a consensus regarding how best to use LABAs in patients with asthma. PMID:20841520

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

    PubMed

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

    2016-07-01

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

  20. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... exclusive marketing rights, FDA will publish this information in the Federal Register at the time of the... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

  1. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... undertake such work through existing or new committees. Whether a particular committee working under such...

  2. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... undertake such work through existing or new committees. Whether a particular committee working under such...

  3. 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

    • 75 FR 31450 - Memorandum of Understanding by and Between the United States Food and Drug Administration and the...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-06-03

      ... Food and Drug Administration and the International Anesthesia Research Society for the Safety of Key... memorandum of understanding (MOU) between FDA and the International Anesthesia Research Society (IARS)....

    • Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis: A Meta-Research Project

      PubMed Central

      Amarilyo, Gil; Furst, Daniel E.; Woo, Jennifer M. P.; Li, Wen; Bliddal, Henning; Christensen, Robin; Tarp, Simon

      2016-01-01

      Background Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. Objectives This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis. Methods Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy. Results FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34) except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61) pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55) pairwise comparisons and were statistically significant in 5. The “signal” in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical. Conclusion There was no empirical evidence to

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

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-06-27

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

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

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-05-01

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

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

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-03-13

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

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

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-03-14

      ... the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Announcement of... Drug Administration Modernization Act AGENCY: Food and Drug Administration, HHS. ACTION:...

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

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-05-01

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

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

      PubMed

      Sunstein, C R

      1998-04-01

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

    • 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

      ..., (76 FR 3825, January 21, 2011), FDA recounted the actions it had already implemented, as well as those... of availability of this report on October 4, 2011 (76 FR 61366), FDA sought public comment on these... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency...

    • Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure--FDA. Notice.

      PubMed

      1998-11-01

      On November 10, 1997, the Food and Drug Administration (FDA), in consultation with the Office for Protection from Research Risks (OPRR) at the National Institutes of Health, requested written comments relating to the proposed republication of the list that identifies certain research activities involving human subjects that may be reviewed by the Institutional Review Board (IRB) through the expedited review procedure authorized in 21 CFR 56.110. The comment period closed on March 10, 1998. FDA and OPRR received a combined total of 108 comments. After a review of the comments, FDA and OPRR are now simultaneously publishing identical revised lists of categories of research activities that may be reviewed by the IRB through the expedited review procedure. PMID:10187395

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

      PubMed

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

      2014-01-01

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

    • A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process

      PubMed Central

      Canfield, Kip; Ritondo, Michele; Sponaugle, Richard

      1998-01-01

      This primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure. PMID:9760391

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

      PubMed

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

      2015-03-01

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

    • 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.

    • 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. PMID:25701283

    • Lectin approaches for glycoproteomics in FDA-approved cancer biomarkers.

      PubMed

      Badr, Haitham A; Alsadek, Dina M M; Darwish, Ashraf A; Elsayed, Abdelaleim I; Bekmanov, Bakhytzhan O; Khussainova, Elmira M; Zhang, Xueji; Cho, William C S; Djansugurova, Leyla B; Li, Chen-Zhong

      2014-04-01

      The nine FDA-approved protein biomarkers for the diagnosis and management of cancer are approaching maturity, but their different glycosylation compositions relevant to early diagnosis still remain practically unexplored at the sub-glycoproteome scale. Lectins generally exhibit strong binding to specific sub-glycoproteome components and this property has been quite poorly addressed as the basis for the early diagnosis methods. Here, we discuss some glycoproteome issues that make tackling the glycoproteome particularly challenging in the cancer biomarkers field and include a brief view for next generation technologies. PMID:24611567

    • Creative penmanship in animal testing prompts FDA controls.

      PubMed

      Smith, R J

      1977-12-23

      Inaccurate science, sloppy science, fraudulent science-these are the greatest threats to the health and safety of the American people. Whether the science is wrong because of clerical error, or because of poor technique, or because of incompetence, or because of negligence, is less important than the fact that it is wrong. For if it is wrong, and if the FDA did not know it was wrong, then the protective regulatory barrier between a potentially dangerous drug and the patient is removed.-SENATOR EDWARD KENNEDY (D-Mass.), in congressional hearings on preclinical testing. PMID:17741687

  1. Awareness of the role of science in the FDA regulatory submission process: a survey of the TERMIS-Americas membership.

    PubMed

    Johnson, Peter C; Bertram, Tim A; Carty, Neal R; Hellman, Kiki B; Tawil, Bill J; Van Dyke, Mark

    2014-06-01

    The Industry Committee of the Tissue Engineering Regenerative Medicine International Society, Americas Chapter (TERMIS-AM) administered a survey to its membership in 2013 to assess the awareness of science requirements in the U.S. Food and Drug Administration (FDA) regulatory process. One hundred forty-four members responded to the survey. Their occupational and geographical representation was representative of the TERMIS-AM membership as a whole. The survey elicited basic demographic information, the degree to which members were involved in tissue engineering technology development, and their plans for future involvement in such development. The survey then assessed the awareness of general FDA scientific practices as well as specific science requirements for regulatory submissions to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Projects (OCP). The FDA-specific questions in the survey were culled from guidance documents posted on the FDA web site ( www.fda.gov ). One of the answer options was an opt-out clause that enabled survey respondents to claim a lack of sufficient awareness of the topic to answer the question. This enabled the stratification of respondents on the basis of confidence in the topic. Results indicate that across all occupational groups (academic, business, and government) that are represented in the TERMIS-AM membership, the awareness of FDA science requirements varies markedly. Those who performed best were for-profit company employees, consultants, and government employees; while students, professors, and respondents from outside the USA performed least well. Confidence in question topics was associated with increased correctness in responses across all groups, though the association between confidence and the ability to answer correctly was poorest among students and professors. Though 80% of

  2. 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

    • Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

      PubMed

      O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah

      2016-08-01

      In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed. PMID:27414000

    • FDA Escherichia coli Identification (FDA-ECID) Microarray: a Pangenome Molecular Toolbox for Serotyping, Virulence Profiling, Molecular Epidemiology, and Phylogeny

      PubMed Central

      Patel, Isha R.; Gangiredla, Jayanthi; Lacher, David W.; Mammel, Mark K.; Jackson, Scott A.; Lampel, Keith A.

      2016-01-01

      ABSTRACT Most Escherichia coli strains are nonpathogenic. However, for clinical diagnosis and food safety analysis, current identification methods for pathogenic E. coli either are time-consuming and/or provide limited information. Here, we utilized a custom DNA microarray with informative genetic features extracted from 368 sequence sets for rapid and high-throughput pathogen identification. The FDA Escherichia coli Identification (FDA-ECID) platform contains three sets of molecularly informative features that together stratify strain identification and relatedness. First, 53 known flagellin alleles, 103 alleles of wzx and wzy, and 5 alleles of wzm provide molecular serotyping utility. Second, 41,932 probe sets representing the pan-genome of E. coli provide strain-level gene content information. Third, approximately 125,000 single nucleotide polymorphisms (SNPs) of available whole-genome sequences (WGS) were distilled to 9,984 SNPs capable of recapitulating the E. coli phylogeny. We analyzed 103 diverse E. coli strains with available WGS data, including those associated with past foodborne illnesses, to determine robustness and accuracy. The array was able to accurately identify the molecular O and H serotypes, potentially correcting serological failures and providing better resolution for H-nontypeable/nonmotile phenotypes. In addition, molecular risk assessment was possible with key virulence marker identifications. Epidemiologically, each strain had a unique comparative genomic fingerprint that was extended to an additional 507 food and clinical isolates. Finally, a 99.7% phylogenetic concordance was established between microarray analysis and WGS using SNP-level data for advanced genome typing. Our study demonstrates FDA-ECID as a powerful tool for epidemiology and molecular risk assessment with the capacity to profile the global landscape and diversity of E. coli. IMPORTANCE This study describes a robust, state-of-the-art platform developed from available

    • 76 FR 48904 - Announcement Regarding the Virgin Islands Triggering “on” Tier Three of Emergency Unemployment...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-08-09

      ... Employment And Training Administration Announcement Regarding the Virgin Islands Triggering ``on'' Tier Three..., Labor. ACTION: Notice. SUMMARY: Announcement regarding the Virgin Islands triggering ``on'' Tier Three... Labor produces a trigger notice indicating which states qualify for EUC08 benefits within Tiers...

    • 75 FR 69134 - Announcement Regarding States Triggering “off” of Tiers Three and Four of Emergency Unemployment...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-11-10

      ... Employment and Training Administration Announcement Regarding States Triggering ``off'' of Tiers Three and..., Labor. ACTION: Notice. SUMMARY: Announcement regarding states triggering ``off'' of Tiers Three and Four... Labor produces a trigger notice indicating which states qualify for EUC08 benefits within Tiers...

    • 76 FR 44611 - Announcement Regarding States Triggering “Off” of Tiers Three and Four of Emergency Unemployment...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-07-26

      ... Employment and Training Administration Announcement Regarding States Triggering ``Off'' of Tiers Three and..., Labor. ACTION: Notice. SUMMARY: Announcement regarding states triggering ``off'' of Tiers Three and Four... Labor produces a trigger notice indicating which states qualify for EUC08 benefits within Tiers...

    • 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

    • 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

    • [Chen Muhua announces nationwide census in 1982].

      PubMed

      1981-03-10

      A nationwide census, only the 3rd in the history of the People's Republic of China, will be taken in July 1982, announced Vice-Premier Chen Muhua at a meeting of the census office under the State Council which opened here today. The 1st census was conducted in 1953, and the 2nd in 1964. Chen, who is in charge of the census, told officials, population specialists and statisticians from across China it was unprecedented in both Chinese history and the history of the world to attempt to count a population that has been long estimated at 1 billion. The census has been proposed in order to ascertain a range of 20 demographic factors necessary for the effective administration of the current economic readjustment and China's modernization drive, the vice-premier said. It will assist family planning and population control, facilitate food and clothing supplies, and make possible assessment of construction needs--housing, hospitals, schools, and other public services, she continued. A great deal of trouble in planning and administration has been caused by the inadequacy of available figures, Chen said. The results will be calculated in 2 stages. Figures such as the number of households and people will be announced first, while other more precise breakdowns such as sex, age, nationality, education, marital status, and occupation will be available later. 2 experimental censuses were carried out in July, 1980. The 950,000 residents in both Wuxi City and Wuxi County in east China's Jiangsu Province, were surveyed. The conference, acting on reports and recommendations from these, will establish further experimental counts in the coming months, while preparatory procedures, organizational work, and regulations are to be discussed and consolidated. The 1982 nationwide census has the support of the UN's fund for population activities. PMID:12338073

    • 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-07-28

      ... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

    • 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-06-07

      ... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance of... application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA...) or a PMA application for the injector alone. For a combination product that includes the...

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

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-07-03

      ... Register of October 21, 2009 (74 FR 54053), FDA announced the availability of the draft guidance documents...-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data--Premarket Approval (PMA...-- Premarket Approval (PMA) and Premarket Notification (510(k)) Submissions'' to the Division of...

    • 77 FR 16971 - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-03-23

      ... against publishing their full texts in the Federal Register ] (51 FR 19851, June 3, 1986). Instead, since....sigelman@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 3, 1974 (39 FR 35697), we announced that copies of all our MOUs transacted with government Agencies...

    • 78 FR 49988 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-08-16

      ... efforts on prevention over the past several years. In the Federal Register of January 16, 2013 (78 FR 3503 and 78 FR 3646), FDA announced the establishment of two dockets so that the public can review the.../GuidanceRegulation/FSMA/default.htm . In the Federal Register of July 29, 2013 (78 FR 45729 and 78 FR...

    • Considering the Future of Pharmaceutical Promotions in Social Media Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

      PubMed

      Carpentier, Francesca Renee Dillman

      2016-01-01

      This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim's article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim's rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA's attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. PMID:27239874

    • Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

      PubMed Central

      Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

      2015-01-01

      Objective To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Design Cohort study. Setting FDA approved novel therapeutics between 1987 and 2014. Population Publicly available sources provided each drug’s year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA’s four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Main outcome measures Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. Results The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an

    • Mining FDA drug labels using an unsupervised learning technique - topic modeling

      PubMed Central

      2011-01-01

      Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

    • Thalidomide, the FDA, and us -- what do you have? Underground compassionate use. Food and Drug Administration.

      PubMed

      1995-01-01

      It comes as no surprise to those in the underground that thalidomide, a TNF-inhibitor, is still defined by its teratogenicity, or ability to cause birth defects. In the late 1950s, thousands of babies were born with horrific birth defects after a company started marketing the drug as safe for morning sickness. Forty years later, after three double blind placebo-controlled studies, numerous case studies, and hundreds of anecdotal reports from doctors treating oral and throat ulcers, the drug is still in clinical trials, and not yet available to treat AIDS-relatetd wasting. Pilot studies of the drug show significant weight gain for patients. In addition, the drug is inexpensive and offers a specific mechanism of inhibiting an inflammatory chemical called TNF-alpha, the substance which presumably aggravates weight loss in people with AIDS. The Underground Thalidomide Compassionate Use Program will begin providing thalidomide as soon as they can secure a safe pharmaceutical supply. PMID:11362280

    • 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

      ... management policy, and educating the general public. DATES: Important dates are as follows: 1. The... . Grants Management Contact Gladys Melendez-Bohler, Office of Acquisition and Grant Services (OAGS), Food... (graduate), staff members and faculty members in the Parties' laboratories, classroom and offices;...

  1. Autologous cell therapies: challenges in US FDA regulation.

    PubMed

    McAllister, Todd N; Audley, David; L'Heureux, Nicolas

    2012-11-01

    Cell-based therapies (CBTs) have been hailed for the last two decades as the next pillar of healthcare, yet the clinical and commercial potential of regenerative medicine has yet to live up to the hype. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. With 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, one must contemplate why CBTs have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. Here, we highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous CBTs. PMID:23210819

  2. [Introduction of U.S. FDA mini-sentinel program].

    PubMed

    Xie, Yan-Ming; Liao, Xing; Shen, Hao

    2013-03-01

    In China, all of traditional Chinese medicine injections should pass clinical trials I, II and III for their safety and effectiveness before coming into the market. However, these clinical tests are mostly restricted to standard treatment for specific groups, and conducted in strict accordance with clinical trial protocols. In the real world, as there are more changes in the post-market clinical application of traditional Chinese medicine injections than in the experiment environment, regulatory bodies set stricter requirements for the post-market re-assessment on traditional Chinese medicine injections. Early-stage studies could only provide the most fundamental and restricted data of efficacy and safety of traditional Chinese medicine injections. In this essay, mini-sentinel program of U. S. FDA is introduced in order to provide reference for large-sample-size post-market clinical safety monitoring studies for traditional Chinese medicine injections. PMID:23724692

  3. Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database

    NASA Astrophysics Data System (ADS)

    Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.

    2012-02-01

    Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

  4. FDA toxicity databases and real-time data entry

    SciTech Connect

    Arvidson, Kirk B.

    2008-11-15

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

  5. 75 FR 21022 - Announcement of Funding Awards for the Housing Choice Voucher Family Self-Sufficiency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ...In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department for funding under Notice PIH 2009-40 (HA) for the Housing Choice Voucher Family Self-Sufficiency (HCV/FSS) Administrative Fee funding. This announcement contains the consolidated names and addresses of......

  6. The National Kidney Foundation Council on Renal Nutrition addresses the Food and Drug Administration.

    PubMed

    Gutekunst, Lisa

    2014-11-01

    On July 24, 2014, the Food and Drug Administration (FDA) held an open forum to review proposed changes to the Nutrition Facts Label and to allow for public comment on these changes. Lisa Gutekunst, MSEd, RD, CSR, CDN, Chair of the National Kidney Foundation Council on Renal Nutrition, lobbied the FDA to add phosphorus to the Nutrition Facts Label. This is her address to the FDA. PMID:25443545

  7. 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.
  1. 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.

  2. 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.

  3. 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

  4. The Conundrum of Online Prescription Drug Promotion Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    PubMed

    Wanasika, Isaac

    2016-01-01

    This commentary discusses pertinent issues from Hyosun Kim's paper on online prescription drug promotion. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration's (FDA's) decision to deregulate online advertising of prescription drugs. While Kim's findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment. PMID:27285519

  5. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010.

    PubMed

    Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E

    2016-04-01

    In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe < 30% (89.6% vs 65.8%, P = .0015). PK studies to assess the impact of dialysis were conducted for 31.7% of NCEs that had a renal study: a greater proportion of high fe NCEs were studied (44.2% vs 26.0%, P = .0335). No significant change in frequency or rigor of PK studies was detected over time. The majority of NCEs (76.3%) with a renal study provided specific dosing recommendations in the API. The adoption of the 1998 FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs. PMID:26238947

  6. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  7. 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

    ... on this topic in March 2010 (75 FR 11893, March 12, 2010) and draft proposals from this phase are... confidentiality of trade secrets and individually identifiable patient information. FDA is seeking public comment... information FDA has in its possession, while supporting the redaction of trade secrets and...

  8. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: Food and Drug... the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current... nanotechnology. The points to consider are intended to be broadly applicable to all FDA-regulated products,...

  9. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... during the development phase of a biosimilar biological product. This draft guidance describes the Agency... development and review of biosimilar biological products. \\1\\ See http://www.fda.gov/downloads/Drugs... between sponsors or applicants and FDA for biosimilar biological product development (BPD) programs. It...

  10. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Committees working under a contract with FDA. 14... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory... public advisory committee. Those principles are set out or cross-referenced in this part and in part...

  11. FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough ... that FDA studies will continue. “We enjoy the science,” says Merkel. “But what’s driving our research is ...

  12. US Food and Drug Administration Web Site: A Primer for Pharmacists.

    PubMed

    Leonard, James; Baker, Danial E

    2015-11-01

    The US Food and Drug Administration (FDA) Web site includes a vast amount of information, but it can be difficult to navigate. Despite frequently asked question (FAQ)-type pages within the Web site, it may not be easy for first-time users to find drug information. This article presents some examples of common questions, provides the locations of the answers on the FDA Web site, and gives a brief description of some of the many resources the FDA provides for health care professionals. Additionally, a newer project being undertaken by the FDA, Snapshot, is introduced. PMID:27621506

  13. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... violate a ban or restriction of the U.S. Food and Drug Administration (FDA) pertaining to such products. If FDA bans or restricts the use of any ingredient in such a way that further manufacture of a product in accordance with its formula would violate the ban or restriction, then the manufacturer...

  14. 77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of July 6, 2012 (77 FR 40069... Spring, MD 20993-0002, 301- 796-3485, astrid.lopezgoldberg@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR... are labeled for human use, and persons who manufacture or cause the manufacture or distribution...

  15. 78 FR 47703 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-06

    ... notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the... ASTM F1091-12 Withdrawn and Standard replaced with Specification for newer version. Wrought Cobalt... Standard replaced with Specification for newer version. Wrought Cobalt- 28Chromium- 6Molybdenum Alloys...

  16. 76 FR 13631 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled...: Table 1--Previous Publications of Standard Recognition Lists February 25, 1998 (63 FR 9561). October 16, 1998 (63 FR 55617). July 12, 1999 (64 FR 37546). November 15, 2000 (65 FR 69022). May 7, 2001 (66...

  17. 78 FR 2998 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled... document. Table 1--Previous Publications of Standard Recognition Lists February 25, 1998 (63 FR 9561) October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001...

  18. 77 FR 50114 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance... this document. Table 1--Previous Publication of Standard Recognition Lists February 25, 1998 (63 FR 9561). October 16, 1998 (63 FR 55617). July 12, 1999 (64 FR 37546). November 15, 2000 (65 FR...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... Federal Register of July 31, 2012 (77 FR 45357), FDA announced the availability of the draft guidance... accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for...

  20. 75 FR 61148 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

    ... requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced... Recognition Lists February 25, 1998 (63 FR 9561) November 8, 2005 (70 FR 67713) October 16, 1998 (63 FR 55617) March 31, 2006 (71 FR 16313) July 12, 1999 (64 FR 37546) June 23, 2006 (71 FR 36121) November 15,...

  1. 76 FR 46300 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the... February 25, 1998 (63 FR 9561) March 31, 2006 (71 FR 16313). October 16, 1998 (63 FR 55617) June 23, 2006 (71 FR 36121). July 12, 1999 (64 FR 37546) November 3, 2006 (71 FR 64718). November 15, 2000 (65...

  2. 75 FR 32943 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced... Recognition Lists February 25, 1998 (63 FR 9561) November 8, 2005 (70 FR 67713) October 16, 1998 (63 FR 55617) March 31, 2006 (71 FR 16313) July 12, 1999 (64 FR 37546) June 23, 2006 (71 FR 36121) November 15,...

  3. 75 FR 24711 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced... Recognition Lists February 25, 1998 (63 FR 9561) May 27, 2005 (70 FR 30756) October 16, 1998 (63 FR 55617) November 8, 2005 (70 FR 67713) July 12, 1999 (64 FR 37546) March 31, 2006 (71 FR 16313) November 15,...

  4. Ocean science educator award announced

    NASA Astrophysics Data System (ADS)

    The Office of Naval Research has announced a program to identify and support academic ocean scientists (“educators”) who have a distinguished record of educating high-quality doctoral and/or postdoctoral students and who will, under this program, draw postdoctoral scientists from other disciplines into the ocean sciences.Named “educators” must be U.S. citizens with research and training experience in the ocean sciences and must have a current research and teaching position at a U.S. institution that confers doctoral degrees in ocean sciences.

  5. Announcement

    NASA Astrophysics Data System (ADS)

    2002-10-01

    A change with the editors of WGN was made. From now on the WGN is prepared by an editorial board and an advisory board consisting of the following members: Editorial board: Marc Gyssens, Rainer Arlt, Alastair McBeath, Jürgen Rendtel and Mihaela Triglav Advisory board: D.J. Asher, M. Beech, P. Brown, M. Currie, M. de Lignie, W.G. Elford, R.L. Hawkes, D.W. Huges, J. Jones, C. Keay, G.W. Kronk, R.H. McNaught, P. Plavec, M. Šimek, G. Spalding, I. Williams.

  6. Announcement

    NASA Astrophysics Data System (ADS)

    2013-08-01

    Volume 79, issue 3, of the Journal of Plasma Physics, contained two papers (Allen, 2013; Lehnert, 2013), which were intended for publication in volume 79, issue 4, a thematic issue dedicated to `Advanced Plasma Concepts'. The Press apologises to the authors concerned, the guest editors of issue 4 and the readers for this error.

  7. 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

  8. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.

    PubMed

    Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

    2013-09-01

    We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. PMID:23362829

  9. An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

    PubMed Central

    Chatterjee, Satabdi; Patel, Harshali K.; Sansgiry, Sujit S.

    Objective To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. Methods Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL), and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market. Results In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6%) followed by unsubstantiated efficacy claims (18.6%). Warning letters were primarily directed to manufacturers of cardiovascular (14.6%), anti-microbial (14.6%), and CNS (12.5%) drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%). Conclusions The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health. PMID:24155837

  10. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    PubMed

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products. PMID:24505852

  11. Repurposing the FDA-Approved Pinworm Drug Pyrvinium as a Novel Chemotherapeutic Agent for Intestinal Polyposis

    PubMed Central

    Giambelli, Camilla; Fei, Dennis Liang; Han, Lu; Hang, Brian I.; Bai, Feng; Pei, Xin-Hai; Nose, Vania; Burlingame, Oname; Capobianco, Anthony J.; Orton, Darren; Lee, Ethan; Robbins, David J.

    2014-01-01

    Mutations in the WNT-pathway regulator ADENOMATOUS POLYPOSIS COLI (APC) promote aberrant activation of the WNT pathway that is responsible for APC-associated diseases such as Familial Adenomatous Polyposis (FAP) and 85% of spontaneous colorectal cancers (CRC). FAP is characterized by multiple intestinal adenomas, which inexorably result in CRC. Surprisingly, given their common occurrence, there are few effective chemotherapeutic drugs for FAP. Here we show that the FDA-approved, anti-helminthic drug Pyrvinium attenuates the growth of WNT-dependent CRC cells and does so via activation of CK1α. Furthermore, we show that Pyrvinium can function as an in vivo inhibitor of WNT-signaling and polyposis in a mouse model of FAP: APCmin mice. Oral administration of Pyrvinium, a CK1α agonist, attenuated the levels of WNT-driven biomarkers and inhibited adenoma formation in APCmin mice. Considering its well-documented safe use for treating enterobiasis in humans, our findings suggest that Pyrvinium could be repurposed for the clinical treatment of APC-associated polyposes. PMID:25003333

  12. A History of the Sonocare CST-100: The First FDA-approved HIFU Device

    NASA Astrophysics Data System (ADS)

    Muratore, Robert

    2006-05-01

    The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

  13. Monitoring Antimicrobial Resistance in the Food Supply Chain and Its Implications for FDA Policy Initiatives.

    PubMed

    Zawack, Kelson; Li, Min; Booth, James G; Love, Will; Lanzas, Cristina; Gröhn, Yrjö T

    2016-09-01

    In response to concerning increases in antimicrobial resistance (AMR), the Food and Drug Administration (FDA) has decided to increase veterinary oversight requirements for antimicrobials and restrict their use in growth promotion. Given the high stakes of this policy for the food supply, economy, and human and veterinary health, it is important to rigorously assess the effects of this policy. We have undertaken a detailed analysis of data provided by the National Antimicrobial Resistance Monitoring System (NARMS). We examined the trends in both AMR proportion and MIC between 2004 and 2012 at slaughter and retail stages. We investigated the makeup of variation in these data and estimated the sample and effect size requirements necessary to distinguish an effect of the policy change. Finally, we applied our approach to take a detailed look at the 2005 withdrawal of approval for the fluoroquinolone enrofloxacin in poultry water. Slaughter and retail showed similar trends. Both AMR proportion and MIC were valuable in assessing AMR, capturing different information. Most variation was within years, not between years, and accounting for geographic location explained little additional variation. At current rates of data collection, a 1-fold change in MIC should be detectable in 5 years and a 6% decrease in percent resistance could be detected in 6 years following establishment of a new resistance rate. Analysis of the enrofloxacin policy change showed the complexities of the AMR policy with no statistically significant change in resistance of both Campylobacter jejuni and Campylobacter coli to ciprofloxacin, another second-generation fluoroquinolone. PMID:27324772

  14. Towards a Computational Analysis of Status and Leadership Styles on FDA Panels

    NASA Astrophysics Data System (ADS)

    Broniatowski, David A.; Magee, Christopher L.

    Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.

  15. Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

    PubMed

    Cohen, Michael H

    2003-01-01

    The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is

  16. Investigating drug repositioning opportunities in FDA drug labels through topic modeling

    PubMed Central

    2012-01-01

    Background Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. Method A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Results Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not

  17. The 2014 FDA assessment of commercial fish: practical considerations for improved dietary guidance.

    PubMed

    McGuire, Jennifer; Kaplan, Jason; Lapolla, John; Kleiner, Rima

    2016-01-01

    The U.S. Food and Drug Administration (FDA) recently released its report: A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children). By evaluating the benefits and potential concerns of eating fish during pregnancy and breastfeeding, the analysis suggests that pregnant women consuming two seafood meals (8-12 oz) per week could provide their child with an additional 3.3 IQ points by age 9. Recent insights from behavioral economics research indicate that other factors, such as concerns about price and methylmercury (MeHg) exposure, appear to reduce fish consumption in many individuals.To assess the net effects of eating commercial fish during pregnancy, we compared the consumption of select fish species necessary to achieve IQ benefits with the amount necessary to have adverse developmental effects due to MeHg exposure. For the species or market types evaluated, the number of servings necessary to reach MeHg exposure to observe an adverse effect was at least twice that the amount estimated to achieve peak developmental benefit. We then reported average costs of fresh and canned or pouched fish, and calculated the cost per week for pregnant women to achieve maximum IQ benefits for their gestating child. Canned light tuna was the least expensive option at $1.83 per week to achieve maximum IQ benefit.Due to their relatively low cost, canned and pouched fish products eaten with enough regularity are likely to provide peak cognitive benefits. Because of its popularity, canned and pouched tuna could provide some of the largest cognitive benefits from fish consumption in the U.S. Future FDA consumer advice and related educational initiatives could benefit from a broader perspective that highlights the importance of affordable and accessible fish choices. These observations underscore the importance of clear public health messaging that address both health

  18. FDA Consumer Nutrition Knowledge Survey. Report II, 1975. A Nationwide Study of Food Shopper's Knowledge, Beliefs, Attitudes and Reported Behavior Regarding Food and Nutrition. Factors Related to Nutrition Labeling.

    ERIC Educational Resources Information Center

    Abelson, Herbert; And Others

    During 1973, a nationwide study for the Food and Drug Administration (FDA) was conducted which provided information on nutrition knowledge, beliefs about nutrition, and first reactions to nutrition labeling among food shoppers. This initial research provided a baseline measurement of nutrition knowledge and attitudes among consumers, and in 1975…

  19. A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"

    PubMed Central

    Butterfield, Lisa H; Disis, Mary L; Fox, Bernard A; Lee, Peter P; Khleif, Samir N; Thurin, Magdalena; Trinchieri, Giorgio; Wang, Ena; Wigginton, Jon; Chaussabel, Damien; Coukos, George; Dhodapkar, Madhav; Håkansson, Leif; Janetzki, Sylvia; Kleen, Thomas O; Kirkwood, John M; Maccalli, Cristina; Maecker, Holden; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Palucka, A Karolina; Potter, Douglas M; Ribas, Antoni; Rivoltini, Licia; Schendel, Dolores; Seliger, Barbara; Selvan, Senthamil; Slingluff, Craig L; Stroncek, David F; Streicher, Howard; Wu, Xifeng; Zeskind, Benjamin; Zhao, Yingdong; Zocca, Mai-Britt; Zwierzina, Heinz; Marincola, Francesco M

    2008-01-01

    The International Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application. Two working groups were created that will report the developed best practices at an NCI/FDA/iSBTc sponsored workshop tied to the annual meeting of the iSBTc to be held in Washington DC in the Fall of 2009. This foreword provides an overview of the task force and invites feedback from readers that might be incorporated in the discussions and in the final document. PMID:19105846

  20. A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

    PubMed Central

    Egger, Gunter F.; Wharton, Gerold T.; Malli, Suzanne; Temeck, Jean; Murphy, M. Dianne; Tomasi, Paolo

    2016-01-01

    Background The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods This is a retrospective review comparing EMA’s Paediatric Committee (PDCO) decisions with FDA’s Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period. Results For single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%). Conclusion Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases.