Science.gov

Sample records for food and drug administration

  1. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ..., 2009, (74 FR 4685, January 26, 2009)). In response, the following June FDA launched its Transparency... Register (75 FR 76011, December 7, 2010) online at http://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative:...

  2. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and...

  3. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and...

  4. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and...

  5. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration manuals. 20.107... Administration manuals. (a) Food and Drug Administration administrative staff manuals and instructions that affect a member of the public are available for public disclosure. An index of all such manuals...

  6. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is not final...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act'' to the Division of...

  7. 75 FR 13766 - Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration--Partnering With Industry; Public Conference AGENCY: Food and Drug Administration,...

  8. 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)...

  9. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  10. 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...

  11. 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...

  12. 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...

  13. 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.''...

  14. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... reportable food that is the subject of a summary posting and that are part of a chain of establishments with... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  15. 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...

  16. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration 2011 Parenteral Drug Association/Food and Drug... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug.... Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and...

  17. 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...

  18. 21 CFR 20.3 - Certification and authentication of Food and Drug Administration records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Certification and authentication of Food and Drug Administration records. 20.3 Section 20.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug Administration...

  19. 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,......

  20. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  1. United States Food and Drug Administration Product Label Changes.

    PubMed

    Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  2. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  3. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATIVE PRACTICES AND PROCEDURES General Administrative Procedures § 10.90 Food and Drug...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

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

  5. 21 CFR 20.2 - Production of records by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... records by Food and Drug Administration employees. (a) Any request for records of the Food and...

  6. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  7. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and...

  8. 21 CFR 20.110 - Data and information about Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Data and information about Food and Drug Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Data and information about Food and Drug Administration employees. (a) The name, title, grade,...

  9. 21 CFR 20.110 - Data and information about Food and Drug Administration employees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Data and information about Food and Drug Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Data and information about Food and Drug Administration employees. (a) The name, title, grade,...

  10. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a)...

  11. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a)...

  12. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a)...

  13. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  14. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  15. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  16. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  17. 21 CFR 20.30 - Food and Drug Administration Freedom of Information Staff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Freedom of Information Staff. 20.30 Section 20.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.30 Food and Drug Administration Freedom...

  18. 21 CFR 5.1105 - Chief Counsel, Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Chief Counsel, Food and Drug Administration. 5.1105 Section 5.1105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1105 Chief Counsel, Food and Drug Administration. The...

  19. 21 CFR 20.28 - Food and Drug Administration determinations of confidentiality.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration determinations of confidentiality. 20.28 Section 20.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.28 Food and Drug Administration determinations of confidentiality. A...

  20. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  1. 21 CFR 5.1105 - Chief Counsel, Food and Drug Administration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chief Counsel, Food and Drug Administration. 5.1105 Section 5.1105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1105 Chief Counsel, Food and Drug Administration. The...

  2. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration... Supplemental Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice of intent. SUMMARY: The Food... Medical Policy, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, rm. 6360, Silver...

  3. 21 CFR 20.29 - Prohibition on withdrawal of records from Food and Drug Administration files.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Prohibition on withdrawal of records from Food and Drug Administration files. 20.29 Section 20.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... withdrawal of records from Food and Drug Administration files. No person may withdraw records submitted...

  4. 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...

  5. 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...

  6. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... predicate tobacco product. Manufacturers of tobacco products first introduced or delivered for...

  7. 78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-12

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: To assist the Food and Drug Administration (FDA or Agency) in drafting a strategic...

  8. 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…

  9. 76 FR 78931 - Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA) Office of Orphan...

  10. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

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

  11. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  12. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  13. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  14. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  15. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  16. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

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

  17. 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...

  18. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  19. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  20. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  1. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  2. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  3. 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...

  4. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  5. 21 CFR 20.32 - Disclosure of Food and Drug Administration employee names.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Disclosure of Food and Drug Administration employee names. 20.32 Section 20.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.32 Disclosure of Food and...

  6. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and...

  7. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  8. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  9. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  10. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  11. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.111 Data and information...

  12. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.111 Data and information...

  13. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for...

  14. Food and Drug Administration Regulation of in Vitro Diagnostic Devices

    PubMed Central

    Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

    2005-01-01

    The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

  15. 21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Conflict of Interest Review Board. 19.10 Section 19.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST General Provisions § 19.10...

  16. 21 CFR 20.31 - Retention schedule of requests for Food and Drug Administration records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Retention schedule of requests for Food and Drug Administration records. 20.31 Section 20.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.31 Retention schedule of requests for...

  17. 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...

  18. Food and Drug Administration regulation and evaluation of vaccines.

    PubMed

    Marshall, Valerie; Baylor, Norman W

    2011-05-01

    The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency. PMID:21502242

  19. 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...

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

    Code of Federal Regulations, 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....

  1. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ..., Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, Texas 75204, 214-253-4952, FAX: 214-253-4970, e-mail: David.Arvelo@fda.hhs.gov . Registration: You are encouraged...

  2. 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,......

  3. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is...

  4. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... CONTACT: Samie Allen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New... HUMAN SERVICES Food and Drug Administration Guidance for Industry and......

  5. 77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  6. 76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  7. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of...

  8. 78 FR 6332 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of...

  9. 77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of...

  10. 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......

  11. 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...

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

    PubMed Central

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

    2013-01-01

    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 safety (46.1%), exhibited greater comprehension of the health risks of smoking and were more likely (48.5%) than other participants (33.6%) to report quit intentions. Risk perceptions partially mediated the relationship between FDA evaluation belief and quit intentions. Conclusions These findings highlight the need for proactive, effective communication to the public about the aims of new tobacco product regulations. PMID:22251767

  13. 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......

  14. Food and Drug Administration Drug Approval Process: A History and Overview.

    PubMed

    Williams, Christopher Ty

    2016-03-01

    In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. PMID:26897420

  15. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  16. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  17. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  18. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  19. Food and Drug Administration workshop on indirect mechanisms of carcinogenesis.

    PubMed

    Poirier, L A

    1996-01-01

    A workshop sponsored by the Food and Drug Administration (FDA) was held on March 4-5, 1996, at the Lister Hill Auditorium of the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop considered both the scientific aspects and the regulatory implications of indirect-acting carcinogens. A wide variety of agents and of prospective mechanisms was discussed. The organizing committee for the workshop consisted of Drs. James Farrelly and Joseph DeGeorge of the Center for Drug Evaluation and Research (CDER), Ronald J. Lorentzen and Sidney Green of the Center for Food Safety and Applied Nutrition (CFSAN), Martin D. Green of the Center for Biologics, Evaluation and Research (CBER), C. Darnell Jackson and Lionel A. Poirier of the National Center for Toxicological Research (NCTR). Rosalie K. Elespuru of the Center for Devices and Radiological Health (CDRH), and David G. Longfellow of the National Cancer Institute (NCI). Following an introduction by Dr. Poirier, who provided a description of indirect carcinogens, the major talks were grouped into three formal sessions: indirect-acting compounds and agents of FDA interest, biological and biochemical endpoints commonly seen with indirect agents, and specific problems associated with the indirect-acting compounds. A panel discussion followed and the concluding remarks were made by Dr. Bernard A. Schwetz, Associate Commissioner for Science, FDA. PMID:8923694

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

    Code of Federal Regulations, 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....

  1. 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....

  2. 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....

  3. 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

  4. 78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug... Administration Safety and Innovation Act (FDASIA). This document is intended to solicit input from all relevant..., and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to provide FDA administrative detention...

  5. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures...

  6. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  7. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  8. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  9. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  10. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1646, Silver Spring... the Internet. A search capability for all Center for Devices and Radiological Health (CDRH) guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and......

  11. Technology assessment and the Food and Drug Administration

    NASA Technical Reports Server (NTRS)

    Kaplan, A. H.; Becker, R. H.

    1972-01-01

    The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

  12. 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...

  13. 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...

  14. 78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... HUMAN SERVICES Food and Drug Administration The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration's (FDA) Office of Orphan Products...

  15. 77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...

  16. 21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration Conflict of Interest... and Drug Administration Conflict of Interest Review Board. (a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall review and make recommendations to...

  17. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD AND... Specific Categories of Records § 20.108 Agreements between the Food and Drug Administration and...

  18. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Food and Drug Administration Web site at http://www.fda.gov once finalized. (c) Agreements and... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD...

  19. 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...

  20. Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.

    PubMed

    Jensen, Valerie; Throckmorton, Douglas C

    2015-08-01

    Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential. PMID:25896999

  1. 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...

  2. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... Global Regulatory Environment AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public... Life Cycle in a Global Regulatory Environment.'' The conference will cover current issues affecting the... facilitate the development and continuous improvement of safe and effective medical products. The...

  3. The food and drug administration agrees to classify mercury fillings.

    PubMed

    Edlich, Richard F; Cross, Catherine L; Wack, Courtney A; Long, William B; Newkirk, Anthony T

    2008-01-01

    In the United States Court of Appeals of the District of Columbia Circuit, the Appellants Mom's Against Mercury, Connecticut Coalition for Environmental Justice, Oregonians for Life, California Citizens for Health Freedom, Kevin J. Biggers, Karen Johnson, Linda Brocato, R. Andrew Landerman, and Antia Vazquez Tibaul filed a petition for review of Regulatory Inaction by the Food and Drug Administration (FDA). On Monday June 2, 2008, the lawsuit was settled with the FDA after it agreed to classify mercury fillings. During its negotiation session with the Appellants, the FDA indicated that it would change its website on mercury fillings. The FDA no longer claims that no science exists about the safety of mercury amalgam or that other countries have acted for environmental reasons only. On its website, the FDA now states the following: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus." The FDA also states that "Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner." The FDA decision to classify mercury fillings is a reflection of the legislations enacted in Europe and Canada that highlight the neurotoxic effects of mercury fillings. PMID:19105536

  4. 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...

  5. 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,...

  6. 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...

  7. 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...

  8. 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...

  9. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... 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...

  10. 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...

  11. 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...

  12. How are drugs approved? Part 1: the evolution of the Food and Drug Administration.

    PubMed

    Howland, Robert H

    2008-01-01

    The discovery, development, and marketing of drugs for clinical use is a process that is complex, arduous, expensive, highly regulated, often criticized, and sometimes controversial. In the United States, the Food and Drug Administration (FDA) is the governmental agency responsible for regulating the development and marketing of drugs, medical devices, biologics, foods, cosmetics, radiation-emitting electronic devices, and veterinary products, with the objective of ensuring their safety and efficacy. As part of a broad overview of the drug development process, this article will describe the historical evolution of the FDA. This will provide background for two subsequent articles in this series, which will describe the ethical foundations of clinical research and hethe stages of drug development. PMID:18251347

  13. 75 FR 60767 - Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... HUMAN SERVICES Food and Drug Administration Office of the Commissioner; Request for Comments on the Food... AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and...- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR...

  14. 75 FR 11893 - Food and Drug Administration Transparency Task Force; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-12

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Task Force... transparent, collaborative, and participatory government. FDA has formed an internal Transparency Task Force..., the Task Force has held two public meetings, on June 24, 2009, and November 3, 2009, and established...

  15. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records §...

  16. Zohydro approval by food and drug administration: controversial or frightening?

    PubMed

    Manchikanti, Laxmaiah; Atluri, Sairam; Candido, Kenneth D; Boswell, Mark V; Simopoulos, Thomas T; Grider, Jay S; Falco, Frank J E; Hirsch, Joshua A

    2014-01-01

    The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health

  17. 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...

  18. 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,...

  19. 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...

  20. 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...

  1. 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...

  2. How the US Food and Drug Administration Can Solve the Prescription Drug Shortage Problem

    PubMed Central

    2013-01-01

    Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections’ focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed—the most frequent cause of drug shortages. PMID:23488502

  3. 21 CFR 20.30 - Food and Drug Administration Division of Freedom of Information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration Division of Freedom... Division of Freedom of Information. (a) The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Information (ELEM-1029), Food and...

  4. 21 CFR 20.30 - Food and Drug Administration Division of Freedom of Information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration Division of Freedom... Division of Freedom of Information. (a) The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Information (ELEM-1029), Food and...

  5. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.105 Section 20.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.105 Testing...

  6. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.105 Section 20.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.105 Testing...

  7. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.105 Section 20.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.105 Testing...

  8. 76 FR 74791 - Memorandum of Understanding Between the Food and Drug Administration and the U.S. Department of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug..., and Food Nutrition Service AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... Food Nutrition Service. The purpose of the MOU is to provide a framework for the parties to...

  9. 21 CFR 20.106 - Studies and reports prepared by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Studies and reports prepared by or with funds provided by the Food and Drug Administration. 20.106 Section 20.106 Food and Drugs FOOD AND DRUG... Categories of Records § 20.106 Studies and reports prepared by or with funds provided by the Food and...

  10. 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...

  11. US Food and Drug Administration draft recommendations on radioactive contamination of food

    SciTech Connect

    Thompson, D.L.

    1995-12-31

    Recommendations on accidental radioactive contamination of human food were issued in 1982 by the Food and Drug Administration (FDA). The recommendations provided guidance to State and local government officials in the exercise of their respective authorities, and were applicable to emergency response planning and to the conduct of radiation protection activities associated with the production, processing, distribution, and use of human food accidentally contaminated with radioactive material. Review of the 1982 FDA recommendations, stimulated by the events following the 1986 accident at Chernobyl, indicated that it would be appropriate to update the recommendations to incorporate newer scientific information and radiation protection philosophy, to include experience gained since 1982, and to take into account international advances. This paper presents a brief outline of the FDA`s approach to its draft revision. the most recent draft was circulated for interagency review in November 1994. Modification made in response to the comments received are included in this paper. 20 refs., 6 tabs.

  12. 76 FR 31345 - Cooperative Arrangement Between the United States Food and Drug Administration and the Inter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... Drug Administration and the Inter-American Institute for Cooperation in Agriculture AGENCY: Food and... Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to...

  13. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20... opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and...

  14. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20... opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and...

  15. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20... opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and...

  16. 75 FR 17418 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Administration, United States Department of Health and Human Services and the National Alliance for Hispanic Health AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  17. Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010622

  18. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... Radiology Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... ``Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology...(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations....

  19. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Testing and research conducted by or with funds... Categories of Records § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and...

  20. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testing and research conducted by or with funds... Categories of Records § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and...

  1. 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)....

  2. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... the Federal Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS... Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance... Cosmetic Act.'' This draft guidance, when finalized, will discuss the meaning of the term ``harmful...

  3. 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...

  4. Computer utilization in the Food and Drug Administration's bureau of foods mass spectrometry laboratory.

    PubMed

    Dreifuss, P A; Dusold, L R

    1982-09-01

    A network of computers is being used to support the Food and Drug Administration's Bureau of Foods mass spectrometry facility. Five mass spectrometers are each interfaced to at least 2 of the 6 dedicated minicomputers in the laboratory. This multiple interfacing provides data acquisition and processing backup, reducing the overall down-time. Selected data from all of the minicomputers can be sent to FDA's main computers via a digital cartridge tape recorder or paper tape. The digital cartridge tape recorder records data that are output from a minicomputer terminal and then plays it back on a terminal which is on-line with the main computer. This main computer stores and edits data; plots spectra for reports, data banks, and publications; and carries out some data processing. Multiple interfacing also serves to supplement the capabilities of the 8-year-old Finnigan MAT (formerly Varian MAT) SS-100 data system (Sperry-Univac/V-76) with the newer and more powerful Finnigan MAT INCOS (Data General/Nova 3) data system. The SS-100 data system is also enhanced by the substitution of the 110 baud paper tape with a 9600 baud cartridge tape recorder for I/O of system bootstraps, BASIC programs, and raw data. PMID:7130097

  5. 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......

  6. 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......

  7. 76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... Differentiation of Influenza Viruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses....

  8. 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...

  9. 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......

  10. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... approval of the HDE application. In the Federal Register of December 13, 2011 (76 FR 77542), FDA issued for... guidance to the Office of Orphan Products (OOPD), Food and Drug Administration, 10903 New Hampshire Ave..., MD 20852. FOR FURTHER INFORMATION CONTACT: Eric Chen, Office of Orphan Products Development...

  11. 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.

  12. 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...

  13. 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......

  14. 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......

  15. 78 FR 12937 - Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... burdensome to institutions, IRBs, and the process of clinical investigation (66 FR 20589 at 20591). The... VIII. Federalism IX. References I. Background In the Federal Register of April 24, 2001 (66 FR 20589... interim rule (66 FR 20589), including the Food and Drug Administration Modernization Act of 1997...

  16. 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...

  17. 77 FR 31026 - Requirements for Importing Food and Drug Administration Regulated Products Into the United States

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ..., IL, 60016. Contact: Lisa Misevicz, Food and Drug Administration, 550 West Jackson Blvd., suite 1500, Chicago, IL 60661; 312-596-4217; email: lisa.misevicz@fda.hhs.gov . Registration: Send registration... July 2, 2012. If you need special accommodations due to a disability, please contact Lisa Misevicz...

  18. Analysis of U.S. Food and Drug Administration food allergen recalls after implementation of the food allergen labeling and consumer protection act.

    PubMed

    Gendel, Steven M; Zhu, Jianmei

    2013-11-01

    To avoid potentially life-threatening reactions, food allergic consumers rely on information on food labels to help them avoid exposure to a food or ingredient that could trigger a reaction. To help consumers in the United States obtain the information that they need, the Food Allergen Labeling and Consumer Protection Act of 2004 defined a major food allergen as being one of eight foods or food groups and any ingredient that contains protein from one of these foods or food groups. A food that contains an undeclared major food allergen is misbranded under the U.S. Food, Drug, and Cosmetic Act and is subject to recall. Food allergen labeling problems are the most common cause of recalls for U.S. Food and Drug Administration (FDA)-regulated food products. To help understand why food allergen recalls continue to occur at a high rate, information on each food allergen recall that occurred in fiscal years 2007 through 2012 was obtained from the FDA recall database. This information was analyzed to identify the food, allergen, root cause, and mode of discovery for each food allergen recall. Bakery products were the most frequently recalled food type, and milk was the most frequently undeclared major food allergen. Use of the wrong package or label was the most frequent problem leading to food allergen recalls. These data are the first reported that indicate the importance of label and package controls as public health measures. PMID:24215698

  19. 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......

  20. 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...

  1. US food and drug administration Indian site inspections: An experience.

    PubMed

    Mahajan, Pooja; D'Souza, Natasha; Bhatt, Arun; Halbe, Vipul; Sharma, Richa; Narayanswamy, Shweta; Bughediwala, Murtuza

    2012-04-01

    Since 2005, USFDA has begun inspections of Indian clinical trial investigator sites. This paper reports experience of an FDA inspection performed at two Indian centers. The inspection started with an in-depth discussion with the investigator and his team about the conduct of the clinical trial at the site and was followed by a tour of the important locations - registration, outpatient department, specialty clinic, medical record section, and special procedure department. The inspector reviewed the critical processes - protocol compliance, ethics committee approval, informed consent process, case record form and source documents completion, investigational product accountability, serious adverse events documentation and reporting. The inspector reviewed all documents from the investigator site file and conducted audit of all subjects enrolled at both the sites. As the Indian sites are not exposed to regulatory inspections, it is vital for the sponsor to conduct preinspection audit, provide training and support to face the FDA inspection. PMID:22701824

  2. Cyberpharmacies and the role of the US Food And Drug Administration.

    PubMed

    Henney, J E

    2001-01-01

    The sale of consumer products over the Internet has grown rapidly, including the sale of drugs. While the growth in online drug sales by reputable pharmacies is a trend that may provide benefits to consumers, online drug sales also present risks to purchasers and some unique challenges to regulators, law enforcement officials and policy makers. The Food and Drug Administration (FDA or the Agency) is concerned about the public health implications of Internet drug sales, and we are responding to these concerns as part of our overall goal of developing and implementing risk-based strategies to protect public health and safety. Although other products regulated by the Agency, such as medical devices, medical test products, foods, dietary supplements and animal drugs also are sold online, this paper focuses on online drug sales. We discuss the advantages and risks of online drug sales, outline FDA's authority and enforcement activities in this area, and describe new initiatives we are taking to better respond to the regulatory challenges we face. PMID:11720945

  3. Cyberpharmacies and the role of the US Food And Drug Administration

    PubMed Central

    2001-01-01

    The sale of consumer products over the Internet has grown rapidly, including the sale of drugs. While the growth in online drug sales by reputable pharmacies is a trend that may provide benefits to consumers, online drug sales also present risks to purchasers and some unique challenges to regulators, law enforcement officials and policy makers. The Food and Drug Administration (FDA or the Agency) is concerned about the public health implications of Internet drug sales, and we are responding to these concerns as part of our overall goal of developing and implementing risk-based strategies to protect public health and safety. Although other products regulated by the Agency, such as medical devices, medical test products, foods, dietary supplements and animal drugs also are sold online, this paper focuses on online drug sales. We discuss the advantages and risks of online drug sales, outline FDA's authority and enforcement activities in this area, and describe new initiatives we are taking to better respond to the regulatory challenges we face. PMID:11720945

  4. 77 FR 24721 - The 15th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The 15th Annual Food and Drug Administration--Orange County... announcing the following conference: The 15th Annual Educational Conference cosponsored with the...

  5. 76 FR 19373 - The 14th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-07

    ... HUMAN SERVICES Food and Drug Administration The 14th Annual Food and Drug Administration-Orange County... announcing the following conference: 14th Annual Educational Conference co-sponsored with the Orange County...: 949-608-4417; or Orange County Regulatory Affairs Discussion Group, Attention to Detail,...

  6. 75 FR 29559 - The 13th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ... HUMAN SERVICES Food and Drug Administration The 13th Annual Food and Drug Administration-Orange County...-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to...-608-4417; or Orange County Regulatory Affairs Discussion Group ] (OCRA), Attention to Detail,...

  7. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  8. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  9. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  10. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  11. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  12. Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration.

    PubMed

    Oram, Matthew

    2016-09-01

    Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration's regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but that the administration supported research to a greater degree than has been recognized. Instead, the decline in research reflected more complex changes in the regulation of pharmaceutical research and development. PMID:27194113

  13. Regulatory aspects of teratology: role of the Food and Drug Administration

    SciTech Connect

    Kelsey, F.O.

    1982-04-01

    The Food and Drug Administration is a scientific regulatory agency whose consumer protection activities cover a wide range of products including foods and additives, and pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting electronic products. Amongst its concerns is the possible teratogen effects of regulated products to which the pregnant woman is exposed. The policies and programs of the agency directed toward reducing such risks to the unborn are reviewed. These measures include guidelines for animal reproduction studies and for clinical trials involving women to childbearing potential; labeling of products to disclose known or possible harm to the fetus or embryo; surveillance procedures designed to detect previously unsuspected adverse effects of marketed products; research activities designed to develop better understanding of developmental toxicology and improved techniques for detecting embryocidal and embryotoxic effects; and educational efforts directed both to professionals and the public regarding hazards to the unborn of agency-regulated products.

  14. 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

  15. 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

  16. 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...

  17. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

    PubMed

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

    Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years. PMID:25613202

  18. The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

    PubMed

    Diehl, David L; Tierney, William M; Adler, Douglas G; Conway, Jason D; Farraye, Francis A; Kantsevoy, Sergey V; Kaul, Vivek; Kethu, Sripathi R; Kwon, Richard S; Mamula, Petar; Pedrosa, Marcos C; Rodriguez, Sarah A

    2010-07-01

    The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment. PMID:20421100

  19. 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...

  20. US Food and Drug Administration international collaborations for cellular therapy product regulation

    PubMed Central

    2012-01-01

    Cellular therapy products are an emerging medical product class undergoing rapid scientific and clinical innovation worldwide. These products pose unique regulatory challenges both for countries with existing regulatory frameworks and for countries where regulatory frameworks for cellular therapy products are under development. The United States Food and Drug Administration (US FDA) has a history of productive working relationships with international regulatory authorities, and seeks to extend this to the cellular therapy field. The US FDA and its global regulatory counterparts are engaged in collaborations focused on the convergence of scientific and regulatory approaches, and the education of scientists, clinicians, regulators, and the public at large on the development of cellular therapies. PMID:23021082

  1. Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration

    PubMed Central

    Sullivan, Helen W.; Aikin, Kathryn J.; Chung-Davies, Eunice; Wade, Michael

    2016-01-01

    The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources. PMID:27149513

  2. Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration.

    PubMed

    Sullivan, Helen W; Aikin, Kathryn J; Chung-Davies, Eunice; Wade, Michael

    2016-01-01

    The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources. PMID:27149513

  3. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... surveillance processes, including application submission, review, compliance with good manufacturing practices... good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation...://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm . Recognizing that many...

  4. 5 CFR 5501.104 - Prohibited financial interests applicable to employees of the Food and Drug Administration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Prohibited financial interests applicable to employees of the Food and Drug Administration. 5501.104 Section 5501.104 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  5. Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. 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 this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010624

  6. 75 FR 73984 - Amendments to General Regulations of the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ...'' (62 FR 62466, November 21, 1997). This guidance document may be accessed at http://www.fda.gov... Act was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and... 1 Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and...

  7. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and... Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401... Evaluations--Volume II: Task Force on the Utilization of Science in Regulatory Decision Making...

  8. Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule.

    PubMed

    1999-11-24

    The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting. PMID:11010690

  9. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug... availability of the draft guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This... should consider, especially during device design and development, and provides recommendations...

  10. 78 FR 6762 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food... produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk... (60 FR 65096, December 18, 1995) and for juice (21 CFR part 120) in 2001 (66 FR 6138, January 19,...

  11. 78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food... human consumption (the produce safety proposed rule) and for current good manufacturing practice and... 1960s, FDA established HACCP-based regulations for seafood (21 CFR part 123) in 1995 (60 FR...

  12. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS... draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to... (510(k)) submission is administratively complete, which determines whether it should be accepted...

  13. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... surveillance processes, including application submission, review, compliance with good manufacturing practices... Act directed FDA to establish appropriate approval procedures and current good manufacturing practices.../DevelopmentApprovalProcess/Manufacturing/ucm085783.htm . Recognizing that many PET drug producers...

  14. Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

    PubMed

    Schneider, Lon S

    2014-03-01

    The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. PMID:24698029

  15. 77 FR 38173 - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct... Agency received significant adverse comment. DATES: The direct final rule published at 77 FR 16923, March... and Drugs, the direct final rule published in the Federal Register on March 23, 2012 (77 FR 16923)...

  16. 76 FR 14030 - Extension of Memorandum of Understanding Between the Food and Drug Administration and Servicio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... and Drug Administration and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the... Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States. The purpose of the MOU is...

  17. Clinical trials for vaccine development in registry of Korea Food and Drug Administration.

    PubMed

    Kang, Seog-Youn

    2013-01-01

    Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop vaccines in the context of self reliance and to protect public health. Along with the recognized infrastructures for clinical trials, clinical trials for vaccines have also gradually been conducted at multinational sites as well as at local sites. KFDA will support to expand six to eleven kinds of vaccines by 2017. In accordance with integrated regulatory system, KFDA has promoted clinical trials, established national lot release procedure, and strengthened good manufacturing practices inspection and post marketing surveillance. Against this backdrop, KFDA will support the vaccine development and promote excellent public health protection. PMID:23596594

  18. Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.

    PubMed

    Regnier, Fred E; Skates, Steven J; Mesri, Mehdi; Rodriguez, Henry; Tezak, Zivana; Kondratovich, Marina V; Alterman, Michail A; Levin, Joshua D; Roscoe, Donna; Reilly, Eugene; Callaghan, James; Kelm, Kellie; Brown, David; Philip, Reena; Carr, Steven A; Liebler, Daniel C; Fisher, Susan J; Tempst, Paul; Hiltke, Tara; Kessler, Larry G; Kinsinger, Christopher R; Ransohoff, David F; Mansfield, Elizabeth; Anderson, N Leigh

    2010-02-01

    As a part of ongoing efforts of the NCI-FDA Interagency Oncology Task Force subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the National Cancer Institute have submitted 2 protein-based multiplex assay descriptions to the Office of In Vitro Diagnostic Device Evaluation and Safety, US Food and Drug Administration. The objective was to evaluate the analytical measurement criteria and studies needed to validate protein-based multiplex assays. Each submission described a different protein-based platform: a multiplex immunoaffinity mass spectrometry platform for protein quantification, and an immunological array platform quantifying glycoprotein isoforms. Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays. PMID:20007858

  19. Testosterone therapy in the new era of Food and Drug Administration oversight

    PubMed Central

    Desroches, Bethany; Kohn, Taylor P.; Welliver, Charles; Pastuszak, Alexander W.

    2016-01-01

    The Food and Drug Administration (FDA) introduced changes in labeling and indications for use to testosterone products in 2015 due to a possible increased risk of cardiovascular (CV) events. This decision was made based on six clinical studies—some that supported an increased CV risk, and some that did not. Since this decision, additional studies have been published examining the interplay between hypogonadism, CV risk, and testosterone, demonstrating that the risk may be lower than originally estimated. Clinicians are placed in a difficult position, as studies support an increased mortality risk in hypogonadal men, but also an increased risk of CV events in men on testosterone therapy. As a result, many clinicians will be more selective in their prescribing of testosterone. In this review, we examine how these new guidelines arose and how they may affect prescribing habits. PMID:27141448

  20. US Food and Drug Administration survey of methyl mercury in canned tuna

    SciTech Connect

    Yess, J.

    1993-01-01

    Methyl mercury was determined by the US Food and Drug Administration (FDA) in 220 samples of canned tuna collected in 1991. Samples were chosen to represent different styles, colors, and packs as available. Emphasis was placed on water-packed tuna, small can size, and the highest-volume brand names. The average methyl mercury (expressed as Hg) found for the 220 samples was 0.17 ppm; the range was <0.10-0.75 ppm. Statistically, a significantly higher level of methyl mercury was found in solid white and chunk tuna. Methyl mercury level was not related to can size. None of the 220 samples had methyl mercury levels that exceeded the 1 ppm FDA action level. 11 refs., 1 tab.

  1. A case for tobacco content regulation by the U.S. Food and Drug Administration

    PubMed Central

    du Toit, J.A.

    2010-01-01

    Although many people welcome the recent move by the United States to give its Food and Drug Administration (fda) the authority to regulate the content of tobacco, some worry that such regulation constitutes unwarranted interference with the freedom of competent adult tobacco consumers. The concern for protecting the autonomy of individuals is valuable indeed, but given the highly addictive nature of tobacco products (and especially the nicotine in tobacco products), the continued use of tobacco by smokers cannot —without straining credulity—be said to be autonomous. This fact, combined with a proper construal of the fda’s role and an appreciation of the substantial morbidity and mortality associated with tobacco use, makes a strong case for content regulation. PMID:20697516

  2. 78 FR 6824 - Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    .... Most people with ALS die from respiratory failure, usually within 3 to 5 years from the onset of...- specific therapy offers hope that new medications or combinations of drugs may one day slow the...

  3. 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......

  4. RU-486: legal and policy issues confronting the Food and Drug Administration.

    PubMed

    Muhl, C

    1993-06-01

    The debate surrounding access to RU-486 in the US resurfaced in July 1992 when a pregnant California Resident attempted to challenge the Food and Drug Administration (FDA) import ban by going through customs at Kennedy International Airport with 12 prescription RU-486 pills she obtained in England. The pills were confiscated and the US Supreme Court denied the woman's request to recover the pills by a 7-2 vote. In 1993, on the 20th anniversary of the Roe v Wade abortion decision, President Clinton instructed the FDA to assess the real health and safety risks of the drug and rescind the ban if politics turns out to be the central issue. FDA has no criteria for measuring acceptable levels of safety, and drug approval is a lengthy process. Moreover, clinical trials are not initiated until a pharmaceutical company applies for FDA approval, which Roussel-Uclaf, RU-486's developer, has not done despite a wealth of safety and effectiveness data amassed in Europe. In fact, fearing a consumer boycott of its other products by US anti-abortion groups, Roussel-Uclaf has limited American researchers' access to RU-486. Despite the pro-choice climate of the Clinton Administration, it is unlikely that RU-486 will be available any time soon to US women, and physicians are concerned that a black market for the drug will emerge. This likelihood has serious consequences for people with Cushing's disease, nonmalignant brain tumors, breast cancer, and other medical conditions that may be responsive to RU-486. Given the experience with the introduction of oral contraceptives, marketed before long-term health consequences had been sufficiently explored, it is essential that FDA researchers investigate the impact of RU-486 on future children, future fertility, its interaction with other medications and contraceptives, and its effects on other bodily systems. At the same time, any risk-benefit assessment must be based on scientific merit, and access to Ru-486 cannot be denied on political

  5. U.S. Food and Drug Administration. "Evaluation Criteria" for Difficult to Compound Drugs.

    PubMed

    Allen, Loyd V

    2015-01-01

    This is part 2 of a 2-part article on the topic of Nominations of Difficult to Compound Drugs to the FDA-PCAC. Part 1 provided a current list of Nominations of Difficult to Compound Drugs to the FDA-PCAC. This article discusses the evaluation procedure for determining which drugs are demonstrably difficult to compound. PMID:26891563

  6. Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges.

    PubMed

    Senior, John R

    2014-11-01

    Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began to show serious and sometimes fatal liver toxicity, we began at the Food and Drug Administration (FDA) a series of annual conferences in 1999 to consider issues of drug-induced liver injury (DILI). First inviting reviewers of new drug applications we opened the audiences in 2001 to pharmaceutical industry and academic consultants to industry and FDA, and slides shown at the meetings were posted on the internet to be available at the website of the American Association for the Study of Liver Diseases (AASLD)-go to ( http://www.aasld.org/dili/Pages/default.aspx ). Observations by Dr. Hyman J. Zimmerman that "drug-induced hepatocellular jaundice is a serious lesion" with possible mortality formed a basis for developing a computer program to plot peak serum values for alanine aminotransferase (ALT) and total bilirubin (TBL) in an x-y log-log graph for all subjects enrolled in clinical trials. This program had the capability to show the time course of all liver tests for individuals who had both hepatocellular injury and reduced whole liver function, plus clinical narratives to diagnose the severity and most likely cause of the abnormalities. We called the program eDISH (for evaluation of Drug-Induced Serious Hepatotoxicity), and began in 2004 to use it to assess DILI in clinical trial subjects. From 2008, comments made by the presenters at the conferences about their slides and ensuing discussions have been added to the website. All this has raised awareness of the problem, and since 1997, the FDA has not had to withdraw a single drug because of post-marketing hepatotoxicity. Many issues still remain to be resolved; among the most controversial is the best method to estimate likelihood that a given liver injury was actually caused by the drug in question. On November 9, 2012, a workshop was convened to discuss the best practices for the assessment of drug-induced liver injury

  7. Impact of a US Food and Drug Administration Drug Safety Communication on Zolpidem Dosing: An Observational Retrospective Cohort

    PubMed Central

    Harward, Jonathan L.; Clinard, Valerie B.; Jiroutek, Michael R.; Lingerfeldt, Beverly H.

    2015-01-01

    Introduction/background: Zolpidem is a sedative-hypnotic widely prescribed in the United States. Recently, the US Food and Drug Administration (FDA) issued a drug safety communication regarding its dosing in women. Objective: To compare compliance with FDA-approved dosing for zolpidem in women before and after a drug safety communication, and to evaluate compliance based on pharmacy location and prescriber type. Method: This was a retrospective, observational cohort study. New prescriptions for Ambien, Ambien CR, Edluar, or Zolpimist or their respective generics dispensed from Kerr Drug pharmacies in North Carolina to women 18–64 years of age between April and September of 2012 (“before” cohort) or April and September of 2013 (“after” cohort) were included. χ2 tests were conducted to assess overall compliance, as well as compliance based on location (urban or rural) and prescriber type (physician or midlevel), with FDA-approved dosing for zolpidem. Trends in total prescription volume and total zolpidem prescription volume for all Kerr Drug pharmacies over the study period were also described. Results: A total of 14,156 prescriptions for zolpidem were included in the primary analysis. Sixteen percent of prescriptions dispensed were in compliance with FDA recommendations following the FDA alert. A statistically significant increase was observed in compliance with FDA-approved dosing for zolpidem (odds ratio = 1.49; 95% CI, 1.35–1.65; P < .0001) postdrug safety communication. Significant increases in compliance were also observed in the post-FDA communication subgroups based on location and prescriber type, though no subgroup was found to be significantly more compliant than another. Conclusions: The release of a drug safety communication by the FDA resulted in a statistically significant increase in proper dosing of zolpidem in women. Further research is needed in order to determine the impact of FDA alerts on prescribing patterns and the reasons for

  8. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... Adolescents.'' When this guidance document is final, several provisions in the Family Smoking Prevention and... Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and...

  9. 77 FR 41418 - Statement of Cooperation Between the Food and Drug Administration and the Secretaria of Health of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ...The Food and Drug Administration (FDA) is providing notice of a Statement of Cooperation (SOC) between FDA and Secretariat of Health (SS) of the United Mexican States, through the Federal Commission for Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to safeguard public health and to ensure the safety and sanitary quality of fresh and frozen molluscan shellfish harvested......

  10. 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...

  11. 78 FR 52202 - Request for Comments on the Food and Drug Administration Safety and Innovation Act Section 907...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All..., 10903 New Hampshire Ave., Bldg. 32, Rm. 2320, Silver Spring, MD 20903, ] 301-796-9441, FDASIASECTION907... subgroups in summaries of product safety and effectiveness and in labeling; on the inclusion of such...

  12. Food and Drug Administration process validation activities to support 99Mo production at Sandia National Laboratories

    SciTech Connect

    McDonald, M.J.; Bourcier, S.C.; Talley, D.G.

    1997-07-01

    Prior to 1989 {sup 99}Mo was produced in the US by a single supplier, Cintichem Inc., Tuxedo, NY. Because of problems associated with operating its facility, in 1989 Cintichem elected to decommission the facility rather than incur the costs for repair. The demise of the {sup 99}Mo capability at Cintichem left the US totally reliant upon a single foreign source, Nordion International, located in Ottawa Canada. In 1992 the DOE purchased the Cintichem {sup 99}Mo Production Process and Drug Master File (DMF). In 1994 the DOE funded Sandia National Laboratories (SNL) to produce {sup 99}Mo. Although Cintichem produced {sup 99}Mo and {sup 99m}Tc generators for many years, there was no requirement for process validation which is now required by the Food and Drug Administration (FDA). In addition to the validation requirement, the requirements for current Good manufacturing Practices were codified into law. The purpose of this paper is to describe the process validation being conducted at SNL for the qualification of SNL as a supplier of {sup 99}Mo to US pharmaceutical companies.

  13. Tobacco advertising and sales practices in licensed retail outlets after the Food and Drug Administration regulations.

    PubMed

    Frick, Ryan G; Klein, Elizabeth G; Ferketich, Amy K; Wewers, Mary Ellen

    2012-10-01

    To assess retailer compliance with Food and Drug Administration (FDA) regulations on tobacco sales and advertising practices, including point-of-sale advertisements, in two distinct Columbus, Ohio neighborhood groups by income. Data were gathered from a random sample of 129 licensed tobacco retailers, which included data on both exterior and interior advertisements as well as sales practices. Descriptive analyses compared retail outlets by high and low income neighborhood locations. Compliance with FDA regulations was high in the random sample of urban tobacco retail outlets. None of the retail outlets sold loose cigarettes or offered free items with purchase. Less than 10% of the outlets surveyed offered self-service access to cigarettes or smokeless tobacco products. From all surveyed retail outlets 95% had cigarette, 57% had smokeless, and 57% had cigar advertisements at the point-of-sale. There were no significant differences in compliance by income, but the mean number of advertisements on the building and self-service access to cigars was significantly different by neighborhood income. There was a high degree of compliance with the new FDA regulation on tobacco marketing and sales practices in urban retail tobacco outlets in Columbus, Ohio. Tobacco advertising and marketing remain highly prevalent in retail outlets, with some significant differences between high and low income neighborhoods. PMID:22197961

  14. 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......

  15. 78 FR 32390 - Food and Drug Administration Safety and Innovation Act (FDASIA): Request for Comments on the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ...): Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology AGENCY: Office of the National Coordinator for Health Information Technology...: The Food and Drug Administration (FDA), Office of the National Coordinator for Health...

  16. 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...

  17. Anti-Obesity Agents and the US Food and Drug Administration.

    PubMed

    Casey, Martin F; Mechanick, Jeffrey I

    2014-09-01

    Despite the growing market for obesity care, the US Food and Drug Administration (FDA) has approved only two new pharmaceutical agents-lorcaserin and combination phentermine/topiramate-for weight reduction since 2000, while removing three agents from the market in the same time period. This article explores the FDA's history and role in the approval of anti-obesity medications within the context of a public health model of obesity. Through the review of obesity literature and FDA approval documents, we identified two major barriers preventing fair evaluation of anti-obesity agents including: (1) methodological pitfalls in clinical trials and (2) misaligned values in the assessment of anti-obesity agents. Specific recommendations include the use of adaptive (Bayesian) design protocols, value-based analyses of risks and benefits, and regulatory guidance based on a comprehensive, multi-platform obesity disease model. Positively addressing barriers in the FDA approval process of anti-obesity agents may have many beneficial effects within an obesity disease model. PMID:26626768

  18. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Pressure Wound Therapy; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction... Device Intended for Negative Pressure Wound Therapy (NPWT)'' to the Division of Small...

  19. 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......

  20. 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......

  1. 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......

  2. 75 FR 73951 - Amendments to General Regulations of the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... procedures for issuing a direct final rule? In the Federal Register of November 21, 1997 (62 FR 62466), FDA... document entitled ``Guidance for FDA and Industry: Direct Final Rule Procedures'' (62 FR 62466). This... Federal Food, Drug, and Cosmetic Act (the FD&C Act) and providing FDA with the authority to...

  3. 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...

  4. 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...

  5. 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......

  6. Food and Drug Administration regulation of diabetes-related mHealth technologies.

    PubMed

    Brooke, M Jason; Thompson, Bradley Merrill

    2013-01-01

    mHealth smartphone applications (apps) offer great promise for managing people with diabetes, as well as those with prediabetes. But to realize that potential, industry needs to get clarity from the U.S. Food and Drug Administration (FDA) regarding the scope of its regulatory oversight. Certain smartphone apps, when properly understood, simply help people live healthier lives, assisting with dietary choices, monitoring exercise, and recording other factors important to overall health. The manufacturers of such apps, in an effort to promote their products but also to educate customers, might wish to explain how using the app can help reduce the risk of developing diabetes. Right now, though, the mere mention of the disease "diabetes" would cause the app to be regulated by the FDA. Such regulation, we submit, discourages the kind of education and motivational messages that our country needs to stem the tide of this disease. Further, should the app simply receive data from a blood glucose meter and graph that data for easier comprehension by the patient, the app would become a class II medical device that requires FDA clearance. Again, we submit that such simple software functionality should not be so discouraged. In this article, we identify the issues that we believe need to be clarified by the FDA in order to unleash the potential of mHealth technology in the diabetes space. PMID:23566984

  7. 77 FR 47078 - 2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... Regulations User Fees Excipient Best Practices Good Manufacturing Practices Foreign Inspections Findings... Submission and Meetings Quality Risk Management Implementation Manufacturing in the Future Quality Systems... Validation Validation FDA Guidance Challenges of Contract Manufacturing Organizations Contract...

  8. Physicochemical characterisation of fluids and soft foods frequently mixed with oral drug formulations prior to administration to children.

    PubMed

    Kersten, E; Barry, A; Klein, S

    2016-03-01

    Oral drug administration to children poses specific pharmaceutical challenges that are often not seen to the same extent in adults, and whose occurrence may also be age dependent. When an age-appropriate dosage form is not available, manipulation of adult dosage forms (e.g., splitting and crushing of tablets or opening of capsules) has been reported as a means to facilitate administration to children. To enhance swallowability and/or mask an unpleasant taste of the dosage form to be administered, crushed/split tablets or the contents of capsules are often mixed with food or drinks or suspended in a vehicle prior to administration. However, it seems that the risks and benefits of an approach whereby the dosage form is modified prior to administration in this manner are everything but clear. The aim of the present study was to gain an overview of the physicochemical properties of a number of fluids, soft foods and suspension vehicles that are commonly reported to be mixed with oral medications before administration to children to improve patient acceptability. For this purpose, physicochemical parameters of 15 different fluids, soft foods and suspension vehicles were measured. These included pH, buffer capacity, osmolality, surface tension and viscosity. Results of the study clearly show the differences in physicochemical properties of the test candidates. It is thus obvious that the type of fluid/food mixed with a drug product before administration may have a significant impact on bioavailability of the drug administered. Therefore, a risk-based assessment of such practices considering API properties, formulation features and physicochemical properties of the fluids and foods intended to be co-administered with the dosage form, in conjunction with the anatomical and physiological maturity of the gastro-intestinal tract in the intended paediatric population, should be an essential part of paediatric oral formulation development. PMID:27183705

  9. The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator.

    PubMed

    Pritchard, W F; Abel, D B; Karanian, J W

    1999-03-01

    The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed. PMID:10069924

  10. 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

  11. 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

  12. Nephrogenic systemic fibrosis and class labeling of gadolinium-based contrast agents by the Food and Drug Administration.

    PubMed

    Yang, Lucie; Krefting, Ira; Gorovets, Alex; Marzella, Louis; Kaiser, James; Boucher, Robert; Rieves, Dwaine

    2012-10-01

    In 2007, the Food and Drug Administration requested that manufacturers of all approved gadolinium-based contrast agents (GBCAs), drugs widely used in magnetic resonance imaging, use nearly identical text in their product labeling to describe the risk of nephrogenic systemic fibrosis (NSF). Accumulating information about NSF risks led to revision of the labeling text for all of these drugs in 2010. The present report summarizes the basis and purpose of this class-labeling approach and describes some of the related challenges, given the evolutionary nature of the NSF risk evidence. The class-labeling approach for presentation of product risk is designed to decrease the occurrence of NSF and to enhance the safe use of GBCAs in radiologic practice. PMID:22923714

  13. Establishing a list of qualifying pathogens under the Food and Drug Administration Safety and Innovation Act. Final rule.

    PubMed

    2014-06-01

    The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of "qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule. PMID:24908687

  14. Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-12-01

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:11503724

  15. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-09-26

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. 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 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997. PMID:11503643

  16. 21 CFR 320.34 - Requirements for batch testing and certification by the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products... include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch... and Drug Administration and found to meet the bioequivalence requirement, unless the public...

  17. 21 CFR 320.34 - Requirements for batch testing and certification by the Food and Drug Administration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products... include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch... and Drug Administration and found to meet the bioequivalence requirement, unless the public...

  18. 76 FR 28046 - Memorandum of Understanding Between the Food and Drug Administration and the International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... Administration and the International Anesthesia Research Society for the Strategies for Mitigating Anesthesia... memorandum of understanding (MOU) 222-09-0014 between the International Anesthesia Research Society...

  19. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ... Pharmaceutical Engineering Co-Sponsorship Educational Workshop: Redefining the `C' in CGMP (Current Good Manufacturing Practices): Creating, Implementing, and Sustaining a Culture of Quality AGENCY: Food and...

  20. 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

  1. 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;...

  2. The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research.

    PubMed

    Kesselheim, Aaron S; Avorn, Jerry

    2012-10-01

    Under Food and Drug Administration (FDA) policy, communications by prescription drug manufacturers must be backed by "substantial evidence" from "adequate and well-controlled investigations." But numerous exceptions permit manufacturer promotion based on data other than randomized trials. The observational research presented in the Hemikrane hypothetical case in this month's Health Affairs is methodologically flawed and also does not meet any of these exceptions. Therefore, plausible scientific and policy rationales support rules restricting the company's communication of its findings. The FDA's current reluctance to authorize promotional claims based on observational research is understandable. Further work is required to define the characteristics of high-quality observational research. However, as this field matures, higher-quality observational studies could meet the legal standard of an "adequate and well-controlled investigation." At that point, the FDA will need to issue formal guidance to minimize confusion on what kinds of observational research can meet its evidentiary standards. PMID:23048097

  3. Evaluating the Impact of U.S. Food and Drug Administration-Proposed Nutrition Facts Label Changes on Young Adults' Visual Attention and Purchase Intentions

    ERIC Educational Resources Information Center

    Graham, Dan J.; Roberto, Christina A.

    2016-01-01

    Background: The U.S. Food and Drug Administration (FDA) has proposed modifying the Nutrition Facts Label (NFL) on food packages to increase consumer attention to this resource and to promote healthier dietary choices. Aims: The present study sought to determine whether the proposed NFL changes will affect consumer attention to the NFL or purchase…

  4. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to... new drug application (NDA), or a device premarket approval application (PMA). DATES: Although you can..., or PMA.'' This document provides guidance to industry and FDA staff on the underlying principles...

  5. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... tuberculosis Complex in Respiratory Specimens; Availability; Microbiology Devices; Reclassification of Nucleic... Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens; Availability AGENCY: Food and Drug... Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in...

  6. 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...

  7. 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…

  8. 78 FR 69543 - Amendments to General Regulations of the Food and Drug Administration; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Federal Register of November 30, 2010 (75 FR 73951), we amended certain regulations in part 1 (21 CFR part... products under the Tobacco Control Act (75 FR 73951 at 73952). However, the revisions inadvertently created... FURTHER INFORMATION CONTACT: Felicia Billingslea, Center for Food Safety and Applied Nutrition...

  9. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., food product, flavor, flavoring extract, or perfume for nonbeverage drawback if its formula would... product in accordance with its formula would violate the ban or restriction, then the manufacturer shall change the formula and resubmit it on TTB Form 5154.1 . This section does not preclude approval...

  10. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., food product, flavor, flavoring extract, or perfume for nonbeverage drawback if its formula would... product in accordance with its formula would violate the ban or restriction, then the manufacturer shall change the formula and resubmit it on TTB Form 5154.1 . This section does not preclude approval...

  11. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., food product, flavor, flavoring extract, or perfume for nonbeverage drawback if its formula would... product in accordance with its formula would violate the ban or restriction, then the manufacturer shall change the formula and resubmit it on TTB Form 5154.1 . This section does not preclude approval...

  12. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., food product, flavor, flavoring extract, or perfume for nonbeverage drawback if its formula would... product in accordance with its formula would violate the ban or restriction, then the manufacturer shall change the formula and resubmit it on TTB Form 5154.1 . This section does not preclude approval...

  13. Neoliberal technocracy: explaining how and why the US Food and Drug Administration has championed pharmacogenomics.

    PubMed

    Hogarth, Stuart

    2015-04-01

    By 2004 the FDA had emerged as a champion of pharmacogenomics as an exemplar for novel approaches to drug development. This was made clear in 2004 when the agency released a wide-ranging report which positioned pharmacogenomics at the heart of a broader regulatory reform agenda. The Critical Path initiative addressed declining productivity of drug development by suggesting that the problem was a mismatch between the rapid pace of discovery in post-genomic biomedicine and the antiquated development process for new drugs. Framing their work in this context, FDA officials reconceptualised their role in the innovation process, in what was the first programmatic statement of a shift from a strictly gate-keeping role to a more collaborative or facilitative role as enablers of innovation. This paper situates the FDA's emergence as a champion of pharmacogenomics in the broader politics of pharmaceutical regulation in the USA. In making a contribution to the pharmaceuticalisation literature this paper will draw on the work of John Abraham who has argued that one of the primary drivers of pharmaceuticalisation has been "deregulatory state policies" and on Williams and colleagues who have argued that the changing relationship between regulatory agencies and the pharmaceutical industry is an important dimension of pharmaceuticalisation. This paper links this to the promotion of pharmaceutical futures such as pharmacogenomics and explores how this shift is also closely related to the trend towards a risk management approach to pharmaceutical regulation. The role of Bush appointees in the development and promotion of the Critical Path agenda is also examined. PMID:25661300

  14. 75 FR 17423 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Administration, United States Department of Health and Human Services and the Association of Minority Health....S. Department of Health and Human Services and the Association of Minority Health Profession...

  15. 77 FR 26768 - Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... manufacturing operations with information on a number of topics concerning FDA requirements and expectations related to current good manufacturing practice (CGMP). The joint public workshop offers the opportunity... Network; (4) IT Strategies--Cloud Computing, RFID, and Beyond; (5) The Future of Drug Manufacturing....

  16. The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update.

    PubMed

    Elahi, Merina; Eshera, Noha; Bambata, Nkosazana; Barr, Helen; Lyn-Cook, Beverly; Beitz, Julie; Rios, Maria; Taylor, Deborah R; Lightfoote, Marilyn; Hanafi, Nada; DeJager, Lowri; Wiesenfeld, Paddy; Scott, Pamela E; Fadiran, Emmanuel O; Henderson, Marsha B

    2016-03-01

    The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products. PMID:26871618

  17. The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

    PubMed Central

    Elahi, Merina; Eshera, Noha; Bambata, Nkosazana; Barr, Helen; Lyn-Cook, Beverly; Beitz, Julie; Rios, Maria; Taylor, Deborah R.; Lightfoote, Marilyn; Hanafi, Nada; DeJager, Lowri; Wiesenfeld, Paddy; Scott, Pamela E.; Henderson, Marsha B.

    2016-01-01

    Abstract The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products. PMID:26871618

  18. The food and drug administration is now preparing to establish tighter performance requirements for blood glucose monitors.

    PubMed

    Klonoff, David C

    2010-05-01

    On March 16 and 17, 2010, the Food and Drug Administration (FDA) presented a public meeting about blood glucose monitoring at the Gaithersberg Hilton Hotel. The meeting was intended to present expert opinions and solicit input from the public about whether to develop new regulatory policies for blood glucose monitors. The meeting was divided into three sections: (1) Clinical Accuracy Requirements for Blood Glucose Monitors, (2) Interferences and Limitations of Blood Glucose Monitors, and (3) Tight Glycemic Control. Many officials from the Center for Devices and Radiologic Health and the Office of In Vitro Diagnostic Devices, which are the parts of FDA that regulate approval of blood glucose monitors, either spoke on the agenda or attended in the audience. Approximately 300 people attended; they were mostly clinicians (such as adult endocrinologists, pediatric endocrinologists, internists, clinical chemists, intensivists, surgeons, nurses, and diabetes educators) or industry officials from companies involved in glucose monitoring, pharmaceutical products, data analysis, or regulatory consulting. PMID:20513313

  19. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    PubMed

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations. PMID:26181187

  20. Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

    PubMed Central

    Kirsch, Irving; Deacon, Brett J; Huedo-Medina, Tania B; Scoboria, Alan; Moore, Thomas J; Johnson, Blair T

    2008-01-01

    Background Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials. Methods and Findings We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug–placebo difference scores. Drug–placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups. Conclusions Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication. PMID:18303940

  1. Clinical chemistry and clinical toxicology devices; classification of B-type natriuretic peptide test system. Food and Drug Administration, HHS. Final rule.

    PubMed

    2001-02-28

    The Food and Drug Administration (FDA) is classifying the B-type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers." 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 device. PMID:11503864

  2. 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

  3. Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.

    PubMed

    Blaus, Alison; Madabushi, Rajanikanth; Pacanowski, Michael; Rose, Martin; Schuck, Robert N; Stockbridge, Norman; Temple, Robert; Unger, Ellis F

    2015-10-13

    Over the past decade, personalized medicine has received considerable attention from researchers, drug developers, and regulatory agencies. Personalized medicine includes identifying patients most likely to benefit and those most likely to experience adverse reactions in response to a drug, and tailoring therapy based on pharmacokinetics or pharmacodynamic response, as well. Perhaps most exciting is finding ways to identify likely responders through genetic, proteomic, or other tests, so that only likely responders will be treated. However, less precise methods such as identifying historical, demographic, or other indicators of increased or reduced responsiveness are also important aspects of personalized medicine. The cardiovascular field has not used many genetic or proteomic markers, but has regularly used prognostic variables to identify likely responders. The development of biomarker-based approaches to personalized medicine in cardiovascular disease has been challenging, in part, because most cardiovascular therapies treat acquired syndromes, such as acute coronary syndrome and heart failure, which develop over many decades and represent the end result of several pathophysiological mechanisms. More precise disease classification and greater understanding of individual variations in disease pathology could drive the development of targeted therapeutics. Success in designing clinical trials for personalized medicine will require the selection of patient populations with attributes that can be targeted or that predict outcome, and the use of appropriate enrichment strategies once such attributes are identified. Here, we describe examples of personalized medicine in cardiovascular disease, discuss its impact on clinical trial design, and provide insight into the future of personalized cardiovascular medicine from a regulatory perspective. PMID:26459078

  4. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug... Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance...

  5. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... by which a repetitive transcranial magnetic stimulation (rTMS) system may comply with the requirement... the special control for rTMS systems, but it remains subject to comment in accordance with the Agency... control for rTMS systems. Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...

  6. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... checklists for use by FDA review staff. In the Federal Register of August 13, 2012 (77 FR 48159), FDA...; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the...

  7. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-12

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. PMID:11010632

  8. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    .... trachomatis and/or N. gonorrhoeae screening and diagnostic testing using nucleic acid based assays. This draft.... trachomatis and/or N. gonorrhoeae screening and diagnostic testing using nucleic acid based assays. These... characteristics of devices that detect chlamydial and/or gonococcal nucleic acid. It does not address detection...

  9. 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...

  10. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... included in IDE and PMA applications, focusing on critical elements of safety and effectiveness...

  11. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus... Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft guidance is not final nor is it in effect... for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA)...

  12. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not... in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday....

  13. 75 FR 48699 - Memorandum of Understanding Between United States Food and Drug Administration and the Centers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-11

    ... collaboration and enhance knowledge of efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to further...

  14. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance...

  15. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... if: ``through either chemical reaction or intermolecular forces or both, the product mediates a... Issues; and Interpretation of the Term ``Chemical Action'' in the Definition of Device Under Section 201...'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in...

  16. 75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-07

    ... (75 FR 13225), FDA published final regulations restricting the sale and distribution of cigarettes and... August 28, 1996 (61 FR 44396)) (Commonwealth Brands, Inc. v. United States, No. 1:09-CV-117-M (W.D. Ky... provision requires that labeling or print advertisements appear in a black-and-white text only...

  17. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... guidance published in the Federal Register on July 12, 2011 (76 FR 40921), and the comment period closed on...; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology... for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.''...

  18. 149 Cong. Rec. H6609 - AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS...

    Code of Federal Regulations, 2011 CFR

    2003-07-14

    ... metropolitan areas. I think that is a very backward-looking cut. What about water and wastewater disposal... communities with homeownership, so essential to helping move our economy out of recession; water and sewer... or in the case of this bill whether we are talking about rural sewer and water grants,...

  19. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

    PubMed Central

    Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

    2012-01-01

    Although radiation therapy is highly safe and effective in treating cancer, recent reports of dangerous radiation-related errors have focused a national spotlight on the field of radiation oncology and, more specifically, on the rapidly evolving and complex nature of radiation devices and how they are regulated. The purpose of this review is to explore the issues involved in medical device regulation in radiation oncology. We start with a general review of federal medical device regulation, including explanations of the legal and regulatory framework, and then discuss issues specific to radiation oncology with real-world examples. We also provide our thoughts on potential solutions and reforms to the current system, including better reporting of radiation-related errors in a centralized database, well-defined criteria for establishing substantial equivalence of a new device, and standard postmarket surveillance of radiation devices. Modern radiation therapy is a powerful tool that can help cure many patients' cancers and alleviate others' suffering with limited adverse effects. We must ensure that this promise is never compromised by avoidable mistakes. PMID:22548012

  20. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability...) is announcing the availability of the draft guidance entitled ``De Novo Classification Process... staff and industry on the process for the submission and review of petitions submitted under the...

  1. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This draft... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  2. 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...

  3. 78 FR 277 - Food and Drug Administration Actions Related to Nicotine Replacement Therapies and Smoking...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-03

    ... hearing that appeared in the Federal Register of November 28, 2012 (77 FR 70955). In the public hearing... to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative... indications for nicotine replacement therapies (NRTs), and input on a report to Congress examining...

  4. 75 FR 42105 - Memorandum of Understanding: Food and Drug Administration and the National Institutes of Health...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... Toxicology Program; and the National Institutes of Health, National Human Genome Research Institute, National... Program (NTP); and the NIH, National Human Genome Research Institute (NHGRI), NIH Chemical Genomics Center... phylogenetically lower animal species (e.g., fish, worms), as well as high throughput whole genome...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... guidance entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical... mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early clinical... of an early feasibility study IDE application and explains the requirements applicable...

  6. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... transmission (primarily hepatitis B) resulting from the use of a blood lancet in multiple patients in various... support the joint Initial Communications issued by CDC and FDA concerning the risk of...

  7. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ...) ``Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation; Draft Guidance for Industry and FDA Staff''; (9) ``Class II Special Controls Guidance Document: Powered Muscle... II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning;...

  8. 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...

  9. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  10. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

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

  11. 75 FR 79379 - Defense Advanced Research Projects Agency and Food and Drug Administration Expanding In Vivo...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... be a transcription of this workshop. SUPPLEMENTARY INFORMATION: Currently available glucose... reliability. For example, many of these technologies are limited to detecting one biomarker (glucose) in real... require frequent secondary testing of blood glucose levels to assure the performance and accuracy of...

  12. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... of January 13, 1989 (54 FR 1602), FDA revoked the exemption for patient examination gloves from... requirements for patient examination gloves. On December 12, 1990 (55 FR 51254), FDA published regulations... Staff; Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use...

  13. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... differentiation of MRSA versus S. aureus (SA) in either human specimens or bacterial growth detected by continuous... detection and differentiation of MRSA versus SA in either human specimens or bacterial growth detected by... the performance characteristics of devices that detect MRSA by growth in culture media or...

  14. Health literacy as controversy: an online community's discussion of the U.S. Food and Drug Administration acetaminophen recommendations.

    PubMed

    Mackert, Michael; Love, Brad; Donovan-Kicken, Erin; Uhle, Katharine A

    2011-12-01

    Adults in the United States increasingly use the Internet for health information, and online discussions can provide insights into public perceptions of health issues. The purpose of this project was to investigate public perceptions of issues related to health literacy, within the context of a conversation about recommendations to the U.S. Food and Drug Administration, driven by concerns about acetaminophen-related liver injuries due in part to health literacy issues. The discussion took place July 2-8, 2009, on a technology/science blog and included 625 comments. Participants debated the risks and benefits of acetaminophen, and most believed responsibility for taking medication safely falls on consumers. Some were implicitly aware of issues related to health literacy and its relationship to patient outcomes; most felt improved education is all that is needed, whereas others acknowledged that health information is confusing--particularly for the elderly and sick. Recommendations for future research into public perceptions of health literacy are discussed. PMID:21788648

  15. Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

    PubMed

    Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J

    2014-08-01

    The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. PMID:24638850

  16. Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration

    PubMed Central

    Herz, Naomi; Loyo-Berrios, Nilsa; Tarver, Michelle

    2014-01-01

    Abstract Background: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS). Methods: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex. Results: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants. Conclusions: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat. PMID:24405314

  17. 75 FR 4407 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... regulatory science, on formulating an appropriate research agenda, and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. Date and Time: The meeting...

  18. Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop.

    PubMed

    Jarow, Jonathan P; Thompson, Ian M; Kluetz, Paul G; Baxley, John; Sridhara, Rajeshwari; Scardino, Peter; Carroll, Peter; Albertsen, Peter; Carter, H Balentine; Brawley, Otis; Sartor, Oliver; Sandler, Howard; Kiefert, James J; Morton, Ronald A

    2014-05-01

    Summary of the discussion at a public workshop cosponsored by the U.S. Food and Drug Administration (FDA) and the American Urological Association reviewing potential trial designs for product and device development for the treatment of localized prostate cancer. Product development for treatment of localized prostate cancer has been stymied by the impracticality of using overall survival as an endpoint in patients with localized disease and the lack of acceptable surrogate endpoints. A workshop evaluating potential trial designs for the development of therapies for localized prostate cancer was held in San Diego, CA, in May 2013. Invited experts represented multiple stakeholders, including urology, medical oncology, radiation oncology, industry, and patient advocates. The expert panel discussed development of products for all risk strata of clinically localized prostate cancer. The panel responded to specific questions from FDA, discussing trial design for patients with low-, intermediate-, and high-risk prostate cancer, focal therapy for prostate cancer, patients who have undergone definitive radiation therapy, and adjuvant therapy for patients undergoing radiation therapy or surgery. Expert commentary provided by the panel will inform a planned FDA guidance on pathways for product and device development for treatment of localized prostate cancer and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to promote the development of new products or devices for the treatment of this disease. PMID:24661332

  19. 77 FR 50113 - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Maureen Dreher or Erica Takai to register (see Contact Person). Registrants will... requirements after registration and will be sent connection access information after November 23, 2012. If...

  20. 76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... Compliance, 76 FR 3825 (January 21, 2011), requiring Federal Agencies to make publicly available compliance... highlighted the achievements of the Environmental Protection Agency (EPA) and the Department of Labor (DOL) in... Memorandum on Transparency and Open Government, 74 FR 4685 (January 26, 2009), which the President issued...

  1. 76 FR 37820 - Proyecto Informar: Food and Drug Administration Hispanic Outreach Initiative (U01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... public health information to millions of Spanish-speaking consumers within the targeted populations... millions of Spanish-speaking consumers within the targeted populations (socially disadvantaged, underserved..., and disability. This program may support a wide range of appropriate innovative education and...

  2. 78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document was... investigations to evaluate medical devices under FDA's IDE regulations. The guidance was also intended to provide... IDE and to provide a general explanation of the reasons for those decisions. This guidance has...

  3. 77 FR 5171 - Further Amendments to General Regulations of the Food and Drug Administration to Incorporate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    ... INFORMATION: I. Background In the Federal Register of April 14, 2011 (76 FR 20901), FDA issued a proposed rule... 22, 2011 (76 FR 36628). B. Section 1.101--Notification and Recordkeeping Section 1.101 (21 CFR 1.101... June 1, 2004 (69 FR 30842). Thus, with regard to tobacco products, FDA intends to exercise...

  4. 76 FR 20901 - Further Amendments to General Regulations of the Food and Drug Administration To Incorporate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... decisions related to misbranding, good manufacturing practice requirements or withdrawal of a tobacco... establishment of good manufacturing practice requirements for tobacco products. Section 910(d)(1) of the Federal... November 12, 2010 (75 FR 69524). B. Section 1.101--Notification and Recordkeeping Section 1.101...

  5. 78 FR 54901 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Ophthalmology Workshop on Developing Novel Endpoints for Premium Intraocular Lenses; Public Workshop AGENCY...) Workshop on Developing Novel Endpoints for Premium Intraocular Lenses.'' The main topic of this workshop is... endpoint methodologies used in evaluating IOL safety and effectiveness. Experts in subjects ranging...

  6. 75 FR 48179 - Comprehensive List of Guidance Documents at the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    .... Background FDA's GGPs were published in the Federal Register of September 19, 2000 (65 FR 56468), and became...) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for... Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution...

  7. 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 ...

  8. A Food and Drug Administration-approved Asthma Therapeutic Agent Impacts Amyloid β in the Brain in a Transgenic Model of Alzheimer Disease*

    PubMed Central

    Hori, Yukiko; Takeda, Shuko; Cho, Hansang; Wegmann, Susanne; Shoup, Timothy M.; Takahashi, Kazue; Irimia, Daniel; Elmaleh, David R.; Hyman, Bradley T.; Hudry, Eloise

    2015-01-01

    Interfering with the assembly of Amyloid β (Aβ) peptides from monomer to oligomeric species and fibrils or promoting their clearance from the brain are targets of anti-Aβ-directed therapies in Alzheimer disease. Here we demonstrate that cromolyn sodium (disodium cromoglycate), a Food and Drug Administration-approved drug already in use for the treatment of asthma, efficiently inhibits the aggregation of Aβ monomers into higher-order oligomers and fibrils in vitro without affecting Aβ production. In vivo, the levels of soluble Aβ are decreased by over 50% after only 1 week of daily intraperitoneally administered cromolyn sodium. Additional in vivo microdialysis studies also show that this compound decreases the half-life of soluble Aβ in the brain. These data suggest a clear effect of a peripherally administered, Food and Drug Administration-approved medication on Aβ economy, supporting further investigation of the potential long-term efficacy of cromolyn sodium in Alzheimer disease. PMID:25468905

  9. 75 FR 34464 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com; Correction of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... that published in the Federal Register of May 26, 2010 (75 FR 29561). The purpose of the cooperative... information and timely content concerning public health and safety topics, including alerts of emerging...

  10. ArrayTrack--supporting toxicogenomic research at the U.S. Food and Drug Administration National Center for Toxicological Research.

    PubMed

    Tong, Weida; Cao, Xiaoxi; Harris, Stephen; Sun, Hongmei; Fang, Hong; Fuscoe, James; Harris, Angela; Hong, Huixiao; Xie, Qian; Perkins, Roger; Shi, Leming; Casciano, Dan

    2003-11-01

    The mapping of the human genome and the determination of corresponding gene functions, pathways, and biological mechanisms are driving the emergence of the new research fields of toxicogenomics and systems toxicology. Many technological advances such as microarrays are enabling this paradigm shift that indicates an unprecedented advancement in the methods of understanding the expression of toxicity at the molecular level. At the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration, core facilities for genomic, proteomic, and metabonomic technologies have been established that use standardized experimental procedures to support centerwide toxicogenomic research. Collectively, these facilities are continuously producing an unprecedented volume of data. NCTR plans to develop a toxicoinformatics integrated system (TIS) for the purpose of fully integrating genomic, proteomic, and metabonomic data with the data in public repositories as well as conventional (Italic)in vitro(/Italic) and (Italic)in vivo(/Italic) toxicology data. The TIS will enable data curation in accordance with standard ontology and provide or interface a rich collection of tools for data analysis and knowledge mining. In this article the design, practical issues, and functions of the TIS are discussed through presenting its prototype version, ArrayTrack, for the management and analysis of DNA microarray data. ArrayTrack is logically constructed of three linked components: a) a library (LIB) that mirrors critical data in public databases; b) a database (MicroarrayDB) that stores microarray experiment information that is Minimal Information About a Microarray Experiment (MIAME) compliant; and c) tools (TOOL) that operate on experimental and public data for knowledge discovery. Using ArrayTrack, we can select an analysis method from the TOOL and apply the method to selected microarray data stored in the MicroarrayDB; the analysis results can be linked directly to

  11. ArrayTrack--supporting toxicogenomic research at the U.S. Food and Drug Administration National Center for Toxicological Research.

    PubMed Central

    Tong, Weida; Cao, Xiaoxi; Harris, Stephen; Sun, Hongmei; Fang, Hong; Fuscoe, James; Harris, Angela; Hong, Huixiao; Xie, Qian; Perkins, Roger; Shi, Leming; Casciano, Dan

    2003-01-01

    The mapping of the human genome and the determination of corresponding gene functions, pathways, and biological mechanisms are driving the emergence of the new research fields of toxicogenomics and systems toxicology. Many technological advances such as microarrays are enabling this paradigm shift that indicates an unprecedented advancement in the methods of understanding the expression of toxicity at the molecular level. At the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration, core facilities for genomic, proteomic, and metabonomic technologies have been established that use standardized experimental procedures to support centerwide toxicogenomic research. Collectively, these facilities are continuously producing an unprecedented volume of data. NCTR plans to develop a toxicoinformatics integrated system (TIS) for the purpose of fully integrating genomic, proteomic, and metabonomic data with the data in public repositories as well as conventional (Italic)in vitro(/Italic) and (Italic)in vivo(/Italic) toxicology data. The TIS will enable data curation in accordance with standard ontology and provide or interface a rich collection of tools for data analysis and knowledge mining. In this article the design, practical issues, and functions of the TIS are discussed through presenting its prototype version, ArrayTrack, for the management and analysis of DNA microarray data. ArrayTrack is logically constructed of three linked components: a) a library (LIB) that mirrors critical data in public databases; b) a database (MicroarrayDB) that stores microarray experiment information that is Minimal Information About a Microarray Experiment (MIAME) compliant; and c) tools (TOOL) that operate on experimental and public data for knowledge discovery. Using ArrayTrack, we can select an analysis method from the TOOL and apply the method to selected microarray data stored in the MicroarrayDB; the analysis results can be linked directly to

  12. 76 FR 45818 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... Processing and Importing of Fish and Fishery Products'' (60 FR 65096, December 18, 1995) (Docket No. FDA-1993...); Procedures for the Safe and Sanitary Processing and Importing of Juice'' (66 FR 6138, January 19, 2001... Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' (72 FR 34752, June 25,...

  13. U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

    PubMed Central

    Alvandi, Firoozeh; Ko, Chia-Wen; Rothmann, Mark D.; Ricci, Stacey; Saber, Haleh; Ghosh, Debasis; Brown, Janice; Pfeiler, Erika; Chikhale, Elsbeth; Grillo, Joseph; Bullock, Julie; Kane, Robert; Kaminskas, Edvardas; Farrell, Ann T.; Pazdur, Richard

    2014-01-01

    On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http://www.tevausa.com) for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). The approval was based on the FDA review of data from 111 patients with CML in CP or in AP who had received two or more prior TKIs, including imatinib. Major cytogenetic response was achieved in 18% of patients with CP, with a median response duration of 12.5 months. Major hematologic response was achieved in 14% of patients with AP, with a median response duration of 4.7 months. The FDA safety evaluation was based on submitted data from 163 patients with CP or AP CML who had received at least one dose of omacetaxine mepesuccinate. The safety evaluation was limited by the single-arm design of the clinical trials as conducted in a small number of previously treated patients. The most common (≥20%) adverse reactions of any grade in enrolled patients included thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, and infection. The FDA concluded that omacetaxine mepesuccinate has shown activity and a favorable benefit-to-risk profile for the studied population of adult patients with CML (CP or AP) with resistance and/or intolerance to two or more TKIs. Further evidence of response durability to verify clinical benefit is pending. PMID:24309980

  14. 21 CFR 70.10 - Color additives in standardized foods and new drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Color additives in standardized foods and new drugs. 70.10 Section 70.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES General Provisions § 70.10 Color additives in standardized foods and new drugs. (a) Standardized foods. (1) Where...

  15. 76 FR 78530 - Applications for Food and Drug Administration Approval To Market a New Drug; Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... several major therapeutic classes are in shortage, including oncology products, antibiotics, and... January 3, 2012 (see the ``Paperwork Reduction Act of 1995'' section of this document). ADDRESSES: You may..., 2007 (72 FR 58993), we (FDA) issued a final rule to revise our postmarketing reporting requirements...

  16. Effect of food intake and co-administration of placebo self-nanoemulsifying drug delivery systems on the absorption of cinnarizine in healthy human volunteers.

    PubMed

    Christiansen, Martin Lau; Holm, Rene; Abrahamsson, Bertil; Jacobsen, Jette; Kristensen, Jakob; Andersen, Jens Rikardt; Müllertz, Anette

    2016-03-10

    Positive food effects may be observed for low aqueous soluble compounds, these effects could potentially be circumvented using lipid based formulations. However, as all compounds are not chemically stable in lipid based systems, alternative dosage regimes could be investigated to evade the stability issue. The two aims for this present study were therefore; i) to investigate if a nutritional drink, Fresubin Energy®, could induce food effect in humans for the poorly soluble compound cinnarizine; and ii) to investigate if co-administration of a self-nano-emulsifying drug delivery systems (SNEDDS) with a conventional cinnarizine tablet could reduce the observed food-effect. A commercial conventional cinnarizine tablet was dosed to 10 healthy volunteers in a cross-over design in both fasted and fed state, with and without co-administration of a SNEDDS, with a one week wash-out period between dosing. The fed state was induced using a nutritional drink (Fresubin Energy®) and gastric emptying was assessed by administration of paracetamol as a marker. The pharmacokinetic analysis showed that the nutritional drink delayed the uptake and increased the fraction of absorbed cinnarizine, indicative of a food effect on the compound. This was in agreement with a previous dog study and indicates that the nutritional drink can be used for inducing the same level of food effect in humans. Though not statistically significant, the co-administration of SNEDDS exhibited a tendency towards a reduction of the observed food effect and an increased absorption of cinnarizine in the fasted state; based upon the individual ratios, which was not reflected in the mean data. However, the co-administration of SNEEDS in the fasted state, also induce a slower gastric emptying rate, which was observed as a delayed tmax for both cinnarizine and paracetamol. PMID:26775868

  17. Agenda-building influences on the news media's coverage of the U.S. Food and Drug Administration's push to regulate tobacco, 1993-2009.

    PubMed

    Foster, Caroline; Thrasher, Jim; Kim, Sei-Hill; Rose, India; Besley, John; Navarro, Ashley

    2012-01-01

    Citing agenda-building theory, this article examines the influence of three key factors on the news media's coverage of the process of placing tobacco and tobacco products under regulation of the U.S. Food and Drug Administration between 1993 and 2009. We analyzed data from a content analysis of 570 news articles from The New York Times and Washington Post and found that the media published significantly more FDA regulation articles during the Clinton administration than during the Bush administration. Our analysis links that imbalance of media coverage to the influence of the president of the United States (Clinton and Bush, during the duration of this study), journalistic routines and real world events. We compared the Clinton and Bush era news coverage on article prominence, article topics, and reasons to support/oppose FDA regulation and found significant differences, which we suggest led to the imbalance of news articles in the two administrations. PMID:23293806

  18. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for... entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for...

  19. 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

  20. [Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases].

    PubMed

    Sasaoka, Sayaka; Matsui, Toshinobu; Abe, Junko; Umetsu, Ryogo; Kato, Yamato; Ueda, Natsumi; Hane, Yuuki; Motooka, Yumi; Hatahira, Haruna; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2016-01-01

    The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 2014, while FAERS contained 5821354 reports from January 2004 to June 2014. In JADER, the RORs [95% confidence interval (CI)] of hand-foot syndrome for capecitabine, tegafur-gimeracil-oteracil, fluorouracil, sorafenib, and regorafenib were 63.60 (95%CI, 56.19-71.99), 1.30 (95%CI, 0.89-1.89), 0.48 (95%CI, 0.30-0.77), 26.10 (95%CI, 22.86-29.80), and 133.27 (95%CI, 112.85-157.39), respectively. Adverse event symptoms of hand-foot syndrome were observed with most anticancer drugs, which carry warnings of the propensity to cause these effects in their drug information literature. The time-to-event analysis using the Weibull shape parameter revealed differences in the time-dependency of the adverse events of each drug. Therefore, anticancer drugs should be used carefully in clinical practice, and patients may require careful monitoring for symptoms of hand-foot syndrome. PMID:26935094

  1. 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

  2. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD...

  3. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement... availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting...

  4. Food and Drug Labeling and the Adult Reader.

    ERIC Educational Resources Information Center

    McKenna, Michael C.; Aker, Richard

    1978-01-01

    Full disclosure of ingredients on food, drugs, and cosmetic labels is really non-disclosure where the chemical formulation has no common name or where one generic name covers a variety of formations. The Food and Drug Administration offers suggestions for adult education programs in consumer awareness, understanding compound nomenclature, and…

  5. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    PubMed

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. PMID:25128009

  6. U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?

    PubMed

    Parker, William H; Kaunitz, Andrew M; Pritts, Elizabeth A; Olive, David L; Chalas, Eva; Clarke-Pearson, Daniel L; Berek, Jonathan S

    2016-01-01

    The U.S. Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were present. The authors, representing a 45-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to asses reliable data regarding patient survival after morcellation. The authors disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery. PMID:26646134

  7. 21 CFR 70.10 - Color additives in standardized foods and new drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Color additives in standardized foods and new drugs. 70.10 Section 70.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... regulation establishing a definition and standard of identity for a food under section 401 of the act,...

  8. 21 CFR 70.10 - Color additives in standardized foods and new drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Color additives in standardized foods and new drugs. 70.10 Section 70.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... regulation establishing a definition and standard of identity for a food under section 401 of the act,...

  9. Monitoring of drug-drug and drug-food interactions.

    PubMed

    Garabedian-Ruffalo, S M; Syrja-Farber, M; Lanius, P M; Plucinski, A

    1988-07-01

    A program for detecting and preventing potentially serious drug-drug and drug-food interactions is described. Two clinical pharmacists developed drug interaction alert (DIA) cards for each potential interaction to be monitored. The cards contain information about the proposed mechanism and potential result of the interaction, as well as information about how to monitor or circumvent the interaction. Staff pharmacists check for the occurrence of potential interactions daily as they verify the filling of the patient-medication cassettes; a poster of all the interactions that are included in the program is posted in each satellite pharmacy to serve as a quick reference for the pharmacists. When a pharmacist detects a potential interaction, he or she completes a DIA card and places it in the medication cassette drawer (if the notice is directed to the nurse) or on the front of the patient's chart (if the notice is directed to the physician). The program was introduced to hospital personnel through inservice education programs and departmental newsletters. The results of a quality assurance review indicated that 95 of 279 (34%) cards dispensed to nurses and 40 of 49 (82%) cards dispensed to physicians resulted in some form of action. The program to detect and prevent potentially serious drug-drug and drug-food interactions has been successful. PMID:3414718

  10. Medication Interactions: Food, Supplements and Other Drugs

    MedlinePlus

    ... Pressure High Blood Pressure Tools & Resources Stroke More Medication Interactions: Food, Supplements and Other Drugs Updated:Oct 15,2014 ... celebrations when eating habits tend to change. Common Medication Interactions Drugs with Food and Beverages Food and drinks don’t mix ...

  11. U.S. Food and Drug Administration perspective of the inclusion of effects of low-level exposures in safety and risk assessment.

    PubMed Central

    Gaylor, D W; Bolger, P M; Schwetz, B A

    1998-01-01

    A brief overview is provided of some of the general safety and risk assessment procedures used by the different centers of the U.S. Food and Drug Administration (U.S. FDA) to evaluate low-level exposures. The U.S. FDA protects public health by regulating a wide variety of consumer products including foods, human and animal drugs, biologics, and medical devices under the federal Food, Drug, and Cosmetic Act. The diverse legal and regulatory standards in the act allow for the consideration of benefits for some products (e.g., drugs) but preclude them from others (e.g., food additives). When not precluded by statutory mandates (e.g., Delaney prohibition), the U.S. FDA considers both physiologic adaptive responses and beneficial effects. For the basic safety assessment paradigm as presently used, for example in the premarket approval of food additives, the emphasis is on the identification of adverse effects and no observed adverse effect level(s) (NOAEL). Generally, the NOAEL is divided by safety factors to establish an acceptable exposure level. This safety assessment paradigm does not preclude the consideration of effects whether they are biologically adaptive or beneficial at lower dose levels. The flexibility to consider issues such as mechanisms of action and adaptive and beneficial responses depends on the product under consideration. For carcinogenic contaminants and radiation from medical devices, the U.S. FDA considers the potential cancer risk at low exposure levels. This generally involves downward extrapolation from the observed dose-response range. The consideration of adverse effects of other toxicologic end points (e.g., reproductive, immunologic, neurologic, developmental) associated with low exposure levels is also becoming more of a reality (e.g., endocrine disrupters). The evaluation of the biologic effects of low-level exposures to toxic substances must include whether the effect is adverse or a normal physiologic adaptive response and also

  12. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES § 1310.11 Reinstatement of exemption for...

  13. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and... the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences...

  14. 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...

  15. 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...

  16. 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...

  17. A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site.

    PubMed

    Nussbaum, David A; Gailloud, Philippe; Murphy, Kieran

    2004-11-01

    In 2002, approximately 38,000 vertebroplasties and 16,000 kyphoplasties were performed in the United States. As the use of both modalities for the treatment of vertebral compression fractures has increased, so have questions regarding safety and efficacy. The authors addressed this by reviewing both the current literature and complications data reported to the Food and Drug Administration (FDA) Center for Devices and Radiological Health through the on-line database (http://www.fda.gov/cdrh/maude.html) and through the Office of the Freedom of Information Act at the FDA. Although both procedures are largely safe, the FDA data highlight two main concerns: reactions to the use of acrylic (polymethylmethacrylate) bone cement, including hypotension and, in some cases, death, especially when multiple vertebral levels are treated in one setting; and a possible increased risk with kyphoplasty of pedicle fracture and cord compression. PMID:15525736

  18. GFR decline as an end point for clinical trials in CKD: a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

    PubMed

    Levey, Andrew S; Inker, Lesley A; Matsushita, Kunihiro; Greene, Tom; Willis, Kerry; Lewis, Edmund; de Zeeuw, Dick; Cheung, Alfred K; Coresh, Josef

    2014-12-01

    The US Food and Drug Administration currently accepts halving of glomerular filtration rate (GFR), assessed as doubling of serum creatinine level, as a surrogate end point for the development of kidney failure in clinical trials of kidney disease progression. A doubling of serum creatinine level generally is a late event in chronic kidney disease (CKD); thus, there is great interest in considering alternative end points for clinical trials to shorten their duration, reduce sample size, and extend their conduct to patients with earlier stages of CKD. However, the relationship between lesser declines in GFR and the subsequent development of kidney failure has not been well characterized. The National Kidney Foundation and Food and Drug Administration sponsored a scientific workshop to critically examine available data to determine whether alternative GFR-based end points have sufficiently strong relationships with important clinical outcomes of CKD to be used in clinical trials. Based on a series of meta-analyses of cohorts and clinical trials and simulations of trial designs and analytic methods, the workshop concluded that a confirmed decline in estimated GFR of 30% over 2 to 3 years may be an acceptable surrogate end point in some circumstances, but the pattern of treatment effects on GFR must be examined, specifically acute effects on estimated GFR. An estimated GFR decline of 40% may be more broadly acceptable than a 30% decline across a wider range of baseline GFRs and patterns of treatment effects on GFR. However, there are other circumstances in which these end points could lead to a reduction in statistical power or erroneous conclusions regarding benefits or harms of interventions. We encourage careful consideration of these alternative end points in the design of future clinical trials. PMID:25441437

  19. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    PubMed Central

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  20. 78 FR 41803 - Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-11

    ... Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138 AGENCY: Food and... the report mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA)...

  1. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... (IFR) on drug shortages published in the Federal Register of December 19, 2011 (76 FR 78530), and... of 1995'' at 76 FR 78537). OMB has approved this information collection under OMB control number 0910... January 8, 2010 (75 FR 1060), and October 18, 2010 (75 FR 63832), and the public comments we received...

  2. United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

    PubMed

    Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

    2014-05-01

    The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. PMID:24623105

  3. US Food and Drug Administration's Risk Evaluation and Mitigation Strategy for extended-release and long-acting opioids: pros and cons, and a European perspective.

    PubMed

    Mercadante, Sebastiano; Craig, David; Giarratano, Antonello

    2012-12-24

    Prescriptions for opioid analgesics to manage moderate-to-severe chronic non-cancer pain have increased markedly over the last decade. An unintentional consequence of greater prescription opioid utilization has been the parallel increase in misuse, abuse and overdose, which are serious risks associated with all opioid analgesics. In response to disturbing rises in prescription opioid abuse, the US Food and Drug Administration (FDA) has proposed the implementation of aggressive Risk Evaluation and Mitigation Strategies (REMS). While REMS could dramatically change the development, release, marketing and prescription of extended-release opioids, questions remain on how these programmes may influence prescribing practices, patient safety and ultimately patient access to these agents. The extent of the availability and misuse of prescription opioids in Europe is difficult to assess from the data currently available, due in large part to the considerable differences in prescribing patterns and regulations between countries. Balancing the availability of prescription opioids for those patients who have pain, while discouraging illicit use, is a complex challenge and requires effective efforts on many levels, particularly in Europe where policies are quite different between countries. PMID:23116252

  4. 78 FR 35155 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... (e.g., plasmids encoding relevant enzymes, etc.). Given the temporal limitations on infectious... resistance encoded on transferable plasmids (Ref. 24). Because Campylobacter infections are common, any... numerous `antibacterial drugs' as a result of the acquisition of multidrug-resistant plasmids. For...

  5. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR 22906...., Bldg. 66, Rm. G424, Silver Spring, MD 20993-0002, 301-796-6438. SUPPLEMENTARY INFORMATION: In FR Doc...; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities;...

  6. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-20

    ... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability... Voluntary Audit Report Submission Program.'' This draft guidance is intended to provide information on the... Voluntary Audit Report Submission Program'' to the Division of Small Manufacturers, International,...

  7. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ...--Requirements for regulatory purposes,'' (ISO 13485:2003) audit report provides FDA a degree of assurance of... Submission Program'' was published for comment in the Federal Register of May 20, 2010 (75 FR 28257... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program;...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

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

  9. Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

    PubMed

    Levey, Andrew S; Cattran, Daniel; Friedman, Aaron; Miller, W Greg; Sedor, John; Tuttle, Katherine; Kasiske, Bertram; Hostetter, Thomas

    2009-08-01

    Changes in proteinuria have been suggested as a surrogate outcome for kidney disease progression to facilitate the conduct of clinical trials. This report summarizes a workshop sponsored by the National Kidney Foundation and US Food and Drug Administration (FDA) with the following goals: (1) to evaluate the strengths and limitations of criteria for assessment of proteinuria as a potential surrogate end point for clinical trials in chronic kidney disease (CKD), (2) to explore the strengths and limitations of available data for proteinuria as a potential surrogate end point, and (3) to delineate what more needs to be done to evaluate proteinuria as a potential surrogate end point. We review the importance of proteinuria in CKD, including the conceptual model for CKD, measurement of proteinuria and albuminuria, and epidemiological characteristics of albuminuria in the United States. We discuss surrogate end points in clinical trials of drug therapy, including criteria for drug approval, the definition of a surrogate end point, and criteria for evaluation of surrogacy based on biological plausibility, epidemiological characteristics, and clinical trials. Next, the report summarizes data for proteinuria as a potential surrogate outcome in 3 broad clinical areas: early diabetic kidney disease, nephrotic syndrome, and diseases with mild to moderate proteinuria. We conclude with a synthesis of data and recommendations for further research. At the present time, there appears to be sufficient evidence to recommend changes in proteinuria as a surrogate for kidney disease progression in only selected circumstances. Further research is needed to define additional contexts in which changes in proteinuria can be expected to predict treatment effect. We recommend collaboration among many groups, including academia, industry, the FDA, and the National Institutes of Health, to share data from past and future studies. PMID:19577347

  10. Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”

    PubMed Central

    Tsai, Chia-Wei; Morris, Stephen

    2015-01-01

    On December 14, 2012, the FDA approved Raxibacumab, the first monoclonal antibody product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or “Animal Rule”). Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. The developmental process required for approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues. PMID:26648915

  11. Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database

    PubMed Central

    Turner, Erick H.; Knoepflmacher, Daniel; Shapley, Lee

    2012-01-01

    Background Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy. Methods and Findings FDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant. Conclusions The magnitude of publication bias found for antipsychotics was less than that found

  12. 75 FR 70932 - Office of the Commissioner of Food and Drugs; Delegation of Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... HUMAN SERVICES Food and Drug Administration Office of the Secretary Office of the Commissioner of Food... Food and Drugs the authorities vested in the Secretary of Health and Human Services under section 4 of... Commissioner of Food and Drugs, or other FDA officials, which involved the exercise of the...

  13. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... clarify the criteria for 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..., suite 200N, Rockville, MD 20852-1448, 301-827-6210. I. Background The PMA regulation (21 CFR...

  14. 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...

  15. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability... Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and... Factors and Usability Engineering to Optimize Medical Device Design'' to the Division of...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... Federal Register of February 16, 2011 (76 FR 9027), FDA issued a draft version of this guidance entitled... includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA... be prescriptive with regard to choice of study design or type of analysis and does not endorse...

  17. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... before it begins work on the final version of the guidance, submit either electronic or written comments... information on electronic access to the guidance. Submit electronic comments on the draft guidance to http... the requirements of the applicable statute and regulations. III. Electronic Access Persons...

  18. Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings.

    PubMed

    O'Donoghue, Amie C; Boudewyns, Vanessa; Aikin, Kathryn J; Geisen, Emily; Betts, Kevin R; Southwell, Brian G

    2015-01-01

    The U.S. Food and Drug Administration's Bad Ad program educates health care professionals about false or misleading advertising and marketing and provides a pathway to report suspect materials. To assess familiarity with this program and the extent of training about pharmaceutical marketing, a sample of 2,008 health care professionals, weighted to be nationally representative, responded to an online survey. Approximately equal numbers of primary care physicians, specialists, physician assistants, and nurse practitioners answered questions concerning Bad Ad program awareness and its usefulness, as well as their likelihood of reporting false or misleading advertising, confidence in identifying such advertising, and training about pharmaceutical marketing. Results showed that fewer than a quarter reported any awareness of the Bad Ad program. Nonetheless, a substantial percentage (43%) thought it seemed useful and 50% reported being at least somewhat likely to report false or misleading advertising in the future. Nurse practitioners and physician assistants expressed more openness to the program and reported receiving more training about pharmaceutical marketing. Bad Ad program awareness is low, but opportunity exists to solicit assistance from health care professionals and to help health care professionals recognize false and misleading advertising. Nurse practitioners and physician assistants are perhaps the most likely contributors to the program. PMID:26176326

  19. Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.

    PubMed

    Shetty, Yashashri C; Saiyed, Aafreen A

    2015-05-01

    The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators, while failure to follow standard operating procedures and maintain documentation was noted as significant in warning letters to IRBs. Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide. PMID:24965716

  20. Association between Selective Serotonin Reuptake Inhibitor Therapy and Suicidality: Analysis of U.S. Food and Drug Administration Adverse Event Reporting System Data.

    PubMed

    Umetsu, Ryogo; Abe, Junko; Ueda, Natsumi; Kato, Yamato; Matsui, Toshinobu; Nakayama, Yoko; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Selective serotonin reuptake inhibitors (SSRIs) are prescribed for the treatment of depression worldwide. SSRIs are suspected to increase the risk of suicidal ideation and behavior (suicidality) in children, adolescents, and young adults. We examined the association between SSRI therapy and suicidality by applying a logistic regression model to age-stratified data from the Food and Drug Administration (FDA) Adverse Event Reporting System database. We attempted to mitigate the effect of patient-related factors by data subsetting. We selected case reports for SSRIs as referred to in the World Health Organization Anatomical Therapeutic Chemical classification code N06AB. The association between SSRIs and "suicidal events" or "self-harm events" was calculated as a reporting odds ratio (ROR) and adjusted for covariates by logistic regression. For subjects <18 years old (y.o.) the adjusted RORs (95% confidence interval) of SSRI therapy with suicidal events were 9.58 (8.97-10.23) in the whole data analysis and 4.64 (4.15-5.19) in the subset analysis; those with self-harm events were 31.40 (27.71-35.58) and 16.31 (13.12-20.29), respectively. Although the adjusted RORs were lower in the subset analyses than in the whole data analyses, both analyses indicated associations between SSRI treatment and suicidal and self-harm events. In both analyses these associations were stronger in the <18 y.o. group than other age groups. Children and adolescents should be closely monitored for the occurrence of suicidality when they are prescribed SSRIs. In addition, we found that data subsetting might mitigate the effect of an intrinsic risk among patients taking the suspected drug. PMID:26521821

  1. 7 CFR 2.57 - Administrator, Food and Nutrition Service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Administrator, Food and Nutrition Service. 2.57... for Food, Nutrition, and Consumer Services § 2.57 Administrator, Food and Nutrition Service. (a... delegations of authority are made by the Under Secretary for Food, Nutrition, and Consumer Services to...

  2. 7 CFR 2.57 - Administrator, Food and Nutrition Service.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Administrator, Food and Nutrition Service. 2.57... for Food, Nutrition, and Consumer Services § 2.57 Administrator, Food and Nutrition Service. (a... delegations of authority are made by the Under Secretary for Food, Nutrition, and Consumer Services to...

  3. 7 CFR 2.57 - Administrator, Food and Nutrition Service.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false Administrator, Food and Nutrition Service. 2.57... for Food, Nutrition, and Consumer Services § 2.57 Administrator, Food and Nutrition Service. (a... delegations of authority are made by the Under Secretary for Food, Nutrition, and Consumer Services to...

  4. 7 CFR 2.57 - Administrator, Food and Nutrition Service.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Administrator, Food and Nutrition Service. 2.57... for Food, Nutrition, and Consumer Services § 2.57 Administrator, Food and Nutrition Service. (a... delegations of authority are made by the Under Secretary for Food, Nutrition, and Consumer Services to...

  5. 7 CFR 2.57 - Administrator, Food and Nutrition Service.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false Administrator, Food and Nutrition Service. 2.57... for Food, Nutrition, and Consumer Services § 2.57 Administrator, Food and Nutrition Service. (a... delegations of authority are made by the Under Secretary for Food, Nutrition, and Consumer Services to...

  6. 77 FR 56650 - Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... increasing importance in the diagnosis and clinical management of glaucoma. Device hardware is often upgraded and innovative software, such as measurement algorithms, image registration, and normative databases, is being added to existing hardware configurations. The optimal endpoints and strategies...

  7. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best...

  8. 75 FR 25869 - The National Institutes of Health and the Food and Drug Administration Joint Leadership Council...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-10

    ... programs to support development of innovative therapies and promote personalized medicine, utilizing new clinical trial design strategies and regulatory review processes incorporating the use of genetic or other... research discoveries into new and approved preventatives, diagnostics, therapies, or devices for...

  9. 76 FR 22905 - Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' With the release of..., 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that... Cigarettes and Smokeless Tobacco to Protect Children and Adolescents'' that were published by FDA on March...

  10. 76 FR 49775 - Food and Drug Administration/National Heart, Lung, and Blood Institute/National Science...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ..., affiliation, address, email, and telephone number. For those without Internet access, please call the contact... services, and other relevant information will be posted, as it becomes available, on the Internet at:...

  11. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ..., and ease of reading. The draft of this guidance issued on September 28, 2010 (75 FR 59726) and the... supersedes the guidance with the same name that issued on April 3, 2007 (72 FR 15888). II. Significance of...; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological...

  12. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... provides recommendations to 510(k) submitters regarding the submission expectations regarding design and... 510(k) submitters (1) Design and test enteral connectors based on the Association for the Advancement... to prevent misconnections; and (3) perform risk assessments to demonstrate that the proposed...

  13. 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) (...

  14. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ...; Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de... entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval... When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological... Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This draft guidance document describes a means by which the herpes simplex virus (HSV) serological assay device...

  16. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... used to image pediatric patients. Exposure to ionizing radiation is of particular concern in pediatric... [insert patient size (e.g., body part thickness or height and weight appropriate to your device)].''...

  17. 75 FR 18849 - Food and Drug Administration/National Heart Lung and Blood Institute/National Science Foundation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... Institute/National Science Foundation Workshop on Computer Methods for Cardiovascular Devices: The... workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices: The Integration... Institute of the National Institutes of Health and the National Science Foundation. The purpose of...

  18. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... begins work on the final version of the guidance, submit electronic or written comments on the draft... section for information on electronic access to the guidance. Submit electronic comments on the draft... the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a...

  19. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... Controls Guidance Document: Topical Oxygen Chamber for Extremities'' (71 FR 17476). Interested persons were... Register of April 6, 2006 (71 FR 17390), FDA's Center for Devices and Radiological Health (CDRH) published...; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability...

  20. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... February 25, 1998 (63 FR 9570). This guidance describes the user fees authorized, updates the previous... the guidance entitled ``30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day... of a guidance for industry entitled ``30-Day Notices, 135-Day Premarket Approval (PMA)...

  1. 75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion, treatment of acute myocardial infarction, treatment of in-stent restenosis and/or post-deployment... the purpose of improving myocardial perfusion, or for treatment of acute myocardial infarction....

  2. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... the pre- Investigational Device Exemption (IDE) program) for medical devices reviewed in the Center... establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and... feedback on future IDE applications prior to their submission. Over time, the pre-IDE program evolved...

  3. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... special controls for class II devices. In the Federal Register of October 4, 2007 (72 FR 56771), and... associated with electrocardiograph electrodes: Adverse tissue reaction to the skin- contacting electrode... either electronic or written comments on this guidance at any time. General comments on agency...

  4. Investigations on non-inferiority--the Food and Drug Administration draft guidance on treatments for nosocomial pneumonia as a case for exact tests for binomial proportions.

    PubMed

    Röhmel, Joachim; Kieser, Meinhard

    2013-06-30

    This paper addresses statistical issues in non-inferiority trials where the primary outcome is a fatal event. The investigations are inspired by a recent Food and Drug Administration (FDA) draft guideline on treatments for nosocomial pneumonia. The non-inferiority margin suggested in this guideline for the endpoint all-cause mortality is defined on different distance measures (rate difference and odds ratio) and is discontinuous. Furthermore, the margin enables considerable power for the statistical proof of non-inferiority at alternatives that might be regarded as clinically unacceptable, that is, even if the experimental treatment is harmful as compared with the control. We investigated the appropriateness of the proposed non-inferiority margin as well as the performance of possible test statistics to be used for the analysis. A continuous variant of the margin proposed in the FDA guideline together with the unconditional exact test according to Barnard showed favorable characteristics with respect to type I error rate control and power. To prevent harmful new treatments from being declared as non-inferior, we propose to add a 'second hurdle'. We discuss examples and explore power characteristics when requiring both statistical significance and overcoming the second hurdle. PMID:22991269

  5. 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

  6. 78 FR 9701 - Draft Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... the elderly, individuals who have a preexisting illness that reduces the effectiveness of their immune system, and pregnant women (Ref. 2). The United States and Canada have experienced sporadic illnesses...

  7. Compelled commercial speech: the Food and Drug Administration's effort to smoke out the tobacco industry through graphic warning labels.

    PubMed

    Haynes, Bryan M; Andrews, Anne Hampton; Jacob, C Reade

    2013-01-01

    FDA's proposed graphic warning labels for cigarette packages have been scrutinized for potentially violating the First Amendment's free speech clause. This article addresses the distinction between the commercial speech and compelled speech doctrines and their applicability in analyzing the constitutionality of the labels. The government's position is that the labels evoke an emotional response and educate consumers, while tobacco companies argue that the labels forcibly promote the government's message. Two federal appellate courts, applying different legal standards, have arrived at different conclusions. This article advocates that the Supreme Court, if faced with review of the labels, should apply strict scrutiny and declare the labels unconstitutional. PMID:24552078

  8. Alteplase Treatment in Acute Stroke: Incorporating Food and Drug Administration Prescribing Information into Existing Acute Stroke Management Guide.

    PubMed

    Demaerschalk, Bart M

    2016-08-01

    Despite strong evidence that intravenous tissue plasminogen activator (tPA) improves outcomes in acute ischemic stroke patients, its use in clinical practice remains modest. Complex eligibility criteria have been postulated as barriers to greater utilization. Further complicating this has been multiple guidelines and prescribing labels that have been published since first being approved for use in 1996. In this review, several warning and exclusion criteria for tPA in acute ischemic stroke are reviewed with the goal of providing readers a nuanced understanding of historical context and available evidence to make informed decision. PMID:27363696

  9. The Impact of the US Food and Drug Administration Chlorofluorocarbon Ban on Out-of-pocket Costs and Use of Albuterol Inhalers Among Individuals With Asthma

    PubMed Central

    Jena, Anupam B.; Ho, Oliver; Goldman, Dana P.; Karaca-Mandic, Pinar

    2015-01-01

    IMPORTANCE The US Clean Air Act prohibits use of nonessential ozone-depleting substances. In 2005, the US Food and Drug Administration announced the ban of chlorofluorocarbon (CFC) albuterol inhalers by December 31, 2008. The policy resulted in the controversial replacement of generic CFC inhalers by more expensive, branded hydrofluoroalkane inhalers. The policy’s impact on out-of-pocket costs and utilization of albuterol is unknown. OBJECTIVE To study the impact of the US Food and Drug Administration’s CFC ban on out-of-pocket costs and utilization of albuterol inhalers. DESIGN, SETTING, AND PARTICIPANTS Using private insurance data from January 1, 2004, to December 31, 2010, we investigated the effect of the CFC ban on out-of-pocket costs and utilization of albuterol inhalers among individuals with asthma (109 428 adults; 37 281 children), as well as asthma-related hospitalizations, emergency department visits, and outpatient visits. We estimated multivariable models adjusted for age, sex, comorbidities, and mean out-of-pocket costs of albuterol inhalers in an individual’s drug plan. We analyzed whether effects varied between adults vs children and those with persistent vs nonpersistent asthma. MAIN OUTCOMES AND MEASURES Pharmacy claims for albuterol inhalers, as well as asthma-related hospitalizations, emergency department visits, and outpatient visits. RESULTS The mean out-of-pocket albuterol cost rose from $13.60 (95% CI, $13.40–$13.70) per prescription in 2004 to $25.00 (95% CI, $24.80–$25.20) immediately after the 2008 ban. By the end of 2010, costs had lowered to $21.00 (95% CI, $20.80–$21.20) per prescription. Overall albuterol inhaler use steadily declined from 2004 to 2010. Steep declines in use of generic CFC inhalers occurred after the fourth quarter of 2006 and were almost fully offset by increases in use of hydrofluoroalkane inhalers. In multivariable analyses, a $10 increase in out-of-pocket albuterol prescription costs was estimated to

  10. Proposed actions for the US Food and Drug Administration to implement to minimize adverse effects associated with energy drink consumption.

    PubMed

    Thorlton, Janet; Colby, David A; Devine, Paige

    2014-07-01

    Energy drink sales are expected to reach $52 billion by 2016. These products, often sold as dietary supplements, typically contain stimulants. The Dietary Supplement Protection Act claims an exemplary public health safety record. However, in 2011 the number of emergency department visits related to consumption of energy drinks exceeded 20,000. Nearly half of these visits involved adverse effects occurring from product misuse. Political, social, economic, practical, and legal factors shape the landscape surrounding this issue. In this policy analysis, we examine 3 options: capping energy drink caffeine levels, creating a public education campaign, and increasing regulatory scrutiny regarding the manufacture and labeling of energy drinks. Increased regulatory scrutiny may be in order, especially in light of wrongful death lawsuits related to caffeine toxicity resulting from energy drink consumption. PMID:24832439

  11. 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...

  12. Derived Intervention Levels for Tritium Based on Food and Drug Administration Methodology Using ICRP 56 Dose Coefficients

    SciTech Connect

    Blanchard, A

    1999-06-09

    In 1998, the FDA released its recommendations for age-dependent derived intervention levels for several radionuclides involved in nuclear accidents. One radionuclide that is not included in that document is tritium. Therefore an analysis is presented here using dose coefficients from ICRP 56 to develop Derived Intervention Levels (DILs) for tritium in two forms: water (HTO) and organically bound tritium (OBT).

  13. Influence of Food on Paediatric Gastrointestinal Drug Absorption Following Oral Administration: A Review

    PubMed Central

    Batchelor, Hannah K.

    2015-01-01

    The objective of this paper was to review existing information regarding food effects on drug absorption within paediatric populations. Mechanisms that underpin food–drug interactions were examined to consider potential differences between adult and paediatric populations, to provide insights into how this may alter the pharmacokinetic profile in a child. Relevant literature was searched to retrieve information on food–drug interaction studies undertaken on: (i) paediatric oral drug formulations; and (ii) within paediatric populations. The applicability of existing methodology to predict food effects in adult populations was evaluated with respect to paediatric populations where clinical data was available. Several differences in physiology, anatomy and the composition of food consumed within a paediatric population are likely to lead to food–drug interactions that cannot be predicted based on adult studies. Existing methods to predict food effects cannot be directly extrapolated to allow predictions within paediatric populations. Development of systematic methods and guidelines is needed to address the general lack of information on examining food–drug interactions within paediatric populations. PMID:27417362

  14. Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation

    PubMed Central

    Tan, Crystal E.; Kyriss, Thomas; Glantz, Stanton A.

    2013-01-01

    Background Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report. Methods and Findings We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalence”) without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act. Conclusions Tobacco companies

  15. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  16. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  17. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  18. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  19. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  20. Food and Drug Administration Approval for Use of Hiberix as a 3-Dose Primary Haemophilus influenzae Type b (Hib) Vaccination Series.

    PubMed

    Briere, Elizabeth C

    2016-01-01

    On January 14, 2016, GlaxoSmithKline Biologicals (Research Triangle Park, North Carolina) received approval from the Food and Drug Administration (FDA) to expand use of Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]) for a 3-dose infant primary vaccination series at ages 2, 4, and 6 months. Hiberix was first licensed in the United States in August 2009 for use as a booster dose in children aged 15 months through 4 years under the Accelerated Approval Regulations, in response to a Haemophilus influenzae type b (Hib) vaccine shortage that lasted from December 2007 to July 2009 (1). Expanding the age indication to include infants provides another vaccine option in addition to other currently licensed monovalent or combination Hib vaccines recommended for the primary vaccination series.* Hiberix contains 10 μg purified capsular polyribosyl ribitolphosphate (PRP) conjugated to 25 μg tetanus toxoid (PRP-T) and is supplied as a single-dose vial of lyophilized vaccine to be reconstituted with saline diluent. For the 3-dose primary series, a single (0.5 mL) dose should be given by intramuscular injection at ages 2, 4, and 6 months; the first dose may be given as early as age 6 weeks. The recommended catch-up schedule for PRP-T vaccines (http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html) should be followed. As previously recommended, a single booster dose should be administered to children aged 15 months through 18 months; to facilitate timely booster vaccination, Hiberix can be administered as early as age 12 months, in accordance with Hib vaccination schedules for routine and catch-up immunization (1-3). PMID:27124887

  1. Pediatric Cardiovascular Clinical Trials: An Analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database

    PubMed Central

    Hill, Kevin D.; Henderson, Heather T.; Hornik, Christoph P.; Li, Jennifer S.

    2015-01-01

    Recent regulatory initiatives in the United States and Europe have transformed the pediatric clinical trials landscape by significantly increasing capital investment and pediatric trial volume. The purpose of this manuscript is to review the impact of these initiatives on the pediatric cardiovascular trials landscape when compared to other pediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major pediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field. PMID:26377725

  2. Characterization of Listeria monocytogenes recovered from imported cheese contributed to the National PulseNet Database by the U.S. Food and Drug Administration from 2001 to 2008.

    PubMed

    Timbo, Babgaleh B; Keys, Christine; Klontz, Karl

    2010-08-01

    Imported foods must meet the same U.S. Food and Drug Administration (FDA) standards as domestic foods. The FDA determines whether an imported food is in compliance with the Federal Food, Drug, and Cosmetic Act. Pursuant to its regulatory activities, the FDA conducts compliance surveillance on imported foods offered for entry into the U.S. commerce. The National PulseNet Database is the molecular surveillance network for foodborne infections and is widely used to provide real-time subtyping support to epidemiologic investigations of foodborne diseases. FDA laboratories use pulsed-field gel electrophoresis to subtype foodborne pathogens recovered from imported foods and submit the molecular patterns to the National PulseNet Database at the Centers for Disease Control and Prevention. There were 60 isolates of Listeria monocytogenes in the FDA Field Accomplishment and Compliance Tracking System from 2001 to 2008 due to cheese imported from the following countries: Mexico (n=21 isolates), Italy (19), Israel (9), Portugal (5), Colombia (3), Greece (2), and Spain (1). We observed genetic diversity of L. monocytogenes isolates and genetic relatedness among strains recovered from imported cheese products coming to the United States from different countries. Consistent characterization of L. monocytogenes isolates recovered from imported cheeses, accompanied by epidemiologic investigations to ascertain human illness associated with these strains, could be helpful in the control of listeriosis acquired from imported cheeses. PMID:20819363

  3. Metal impurities in food and drugs.

    PubMed

    Abernethy, Darrell R; Destefano, Anthony J; Cecil, Todd L; Zaidi, Kahkashan; Williams, Roger L

    2010-05-01

    The major metals of potential health concern found in food, drugs (medicines), and dietary supplements are lead, cadmium, mercury, and arsenic. Other metals, such as chromium, copper, manganese, molybdenum, vanadium, nickel, osmium, rhodium, ruthenium, iridium, palladium, and platinum, may be used or introduced during manufacturing and may be controlled in the final article as impurities. Screening for metals in medicines and dietary supplements rarely indicates the presence of toxic metal impurities at levels of concern. The setting of heavy metal limits is appropriate for medicines and is appropriate for supplements when heavy metals are likely or certain to contaminate a given product. Setting reasonable health-based limits for some of these metals is challenging because of their ubiquity in the environment, limitations of current analytical procedures, and other factors. Taken together, compendial tests for metals in food and drugs present an array of issues that challenge compendial scientists. PMID:20217462

  4. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  5. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  6. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  7. 21 CFR 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.100 Submission of a premarket... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). 170.100 Section 170.100 Food and...

  8. A resolution expressing the sense of the Senate that the Food and Drug Administration should encourage the use of abuse-deterrent formulations of drugs.

    THOMAS, 113th Congress

    Sen. Coburn, Tom [R-OK

    2013-04-15

    04/15/2013 Referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2654) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  9. Cholinergic modulation of food and drug satiety and withdrawal.

    PubMed

    Avena, Nicole M; Rada, Pedro V

    2012-06-01

    Although they comprise only a small portion of the neurons in the region, cholinergic interneurons in the dorsal striatum appear to play an important role in the regulation of various appetitive behaviors, in part, through their interactions with mesolimbic dopamine (DA) systems. In this review, we describe studies that suggest that the activity of cholinergic interneurons in the nucleus accumbens (NAc) and cholinergic projections to the ventral tegmental area (VTA) affect feeding behavior. In vivo microdialysis studies in rats have revealed that the cessation of a meal is associated with a rise in acetylcholine (ACh) levels in the NAc. ACh activation will suppress feeding, and this is also associated with an increase in synaptic accumulation of ACh. Further, we discuss how, in addition to their role in the ending of a meal, cholinergic interneurons in the NAc play an integral role in the cessation of drug use. Another cholinergic system involved in different aspects of appetitive behavior is the projection from the pedunculpontine nuclei directly to the VTA. Activation of this system enhances behaviors through activation of the mesolimbic DA system, and antagonism of ACh receptors in the VTA can reduce drug self-administration. Finally, we discuss the role of accumbens ACh in both drug and palatable food withdrawal. Studies reveal that accumbens ACh is increased during withdrawal from several different drugs of abuse (including cocaine, nicotine and morphine). This rise in extracellular levels of ACh, coupled with a decrease in extracellular levels of DA, is believed to contribute to an aversive state, which can manifest as behaviors associated with drug withdrawal. This theory has also been applied to studies of overeating and/or "food addiction," and the findings suggest a similar imbalance in DA/ACh levels, which is associated with behavioral indications of drug-like withdrawal. In summary, cholinergic neurons play an important role in the modulation of both

  10. Herb-drug, food-drug, nutrient-drug, and drug-drug interactions: mechanisms involved and their medical implications.

    PubMed

    Sørensen, Janina Maria

    2002-06-01

    Adverse drug reactions (ADRs) and iatrogenic diseases have been identified as significant factors responsible for patient morbidity and mortality. Significant studies on drug metabolism in humans have been published during the last few years, offering a deeper comprehension of the mechanisms underlying adverse drug reactions and interactions. More understanding of these mechanisms, and of recent advances in laboratory technology, can help to evaluate potential drug interactions when drugs are prescribed concurrently. Increasing knowledge of interindividual variation in drug breakdown capacity and recent findings concerning the influence of environment, diet, nutrients, and herbal products can be used to reduce ADRs and iatrogenic diseases. Reviewed data suggest that drug treatment should be increasingly custom tailored to suit the individual patient and that appropriately co-prescribed diet and herbal remedies, could increase drug efficacy and lessen drug toxicity. This review focuses mainly on recently published research material. The cytochrome p450 enzymes, their role in metabolism, and their mechanisms of action are reviewed, and their role in drug-drug interactions are discussed. Drug-food and drug-herb interactions have garnered attention. Interdisciplinary communication among medical herbalists, medical doctors, and dietetic experts needs to be improved and encouraged. Internet resources for obtaining current information regarding drug-drug, drug-herb, and drug-nutrient interactions are provided. PMID:12165187

  11. The effects of exercise on cocaine self-administration, food-maintained responding, and locomotor activity in female rats: importance of the temporal relationship between physical activity and initial drug exposure.

    PubMed

    Smith, Mark A; Witte, Maryam A

    2012-12-01

    Previous studies have reported that exercise decreases cocaine self-administration in rats with long-term access (8+ weeks) to activity wheels in the home cage. The purpose of this study was to (a) examine the importance of the temporal relationship between physical activity and initial drug exposure, (b) determine the effects of exercise on responding maintained by a nondrug reinforcer (i.e., food), and (c) investigate the effects of exercise on cocaine-induced increases in locomotor activity. To this end, female rats were obtained at weaning and divided into 4 groups: (a) EXE-SED rats were housed in exercise cages for 6 weeks and then transferred to sedentary cages after the first day of behavioral testing; (b) SED-EXE rats were housed in sedentary cages for 6 weeks and then transferred to exercise cages after the first day of behavioral testing; (c) SED-SED rats remained in sedentary cages for the duration of the study; and (d) EXE-EXE rats remained in exercise cages for the duration of the study. Relative to the sedentary group (SED-SED), exercise reduced cocaine self-administration in both groups with access to activity wheels after initial drug exposure (EXE-EXE, SED-EXE) but did not reduce cocaine self-administration in the group with access to activity wheels only before drug exposure (EXE-SED). Exercise also decreased the effects of cocaine on locomotor activity but did not reduce responding maintained by food. These data suggest that exercise may reduce cocaine use in drug-experienced individuals with no prior history of aerobic activity without decreasing other types of positively reinforced behaviors. PMID:22924703

  12. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR)

    PubMed Central

    Moore, Thomas J.; Bennett, Charles L.

    2014-01-01

    The U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS), familiarly known as “MedWatch,” is the nation's primary tool for postmarket pharmaceutical safety surveillance. This system relies on adverse events voluntarily reported by health care providers and consumers either directly to the FDA or to drug manufacturers, which are required to prepare and forward the information to the agency. Little is known about how frequently adverse events are reported. Previous estimates range from 1 to 31% depending on the event, drug, and time period. We used published incidence studies to calculate reporting rates for hemorrhage, emergency hospitalization, and venous thromboembolism (VTE) associated with four drugs. We estimated annual reporting rates of 1.07% for 33,171 emergency hospitalizations of patients older than 65 years associated with warfarin, 0.9% for 13,363 hospitalizations of clopidogrel and ticlopidine, and 1.02% for an estimated 67,200 hemorrhage cases associated with warfarin. We also estimated a 9-year reporting rate of 2.3% for VTE associated with thalidomide. The incidence of these hematologic adverse drug events is high and reporting rates are low, and near the lower boundary of the 1 to 15% range seen for other events. PMID:23086541

  13. Food-Drug Interactions

    PubMed Central

    Bushra, Rabia; Aslam, Nousheen; Khan, Arshad Yar

    2011-01-01

    The effect of drug on a person may be different than expected because that drug interacts with another drug the person is taking (drug-drug interaction), food, beverages, dietary supplements the person is consuming (drug-nutrient/food interaction) or another disease the person has (drug-disease interaction). A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. These interactions may occur out of accidental misuse or due to lack of knowledge about the active ingredients involved in the relevant substances. Regarding food-drug interactions physicians and pharmacists recognize that some foods and drugs, when taken simultaneously, can alter the body's ability to utilize a particular food or drug, or cause serious side effects. Clinically significant drug interactions, which pose potential harm to the patient, may result from changes in pharmaceutical, pharmacokinetic, or pharmacodynamic properties. Some may be taken advantage of, to the benefit of patients, but more commonly drug interactions result in adverse drug events. Therefore it is advisable for patients to follow the physician and doctors instructions to obtain maximum benefits with least food-drug interactions. The literature survey was conducted by extracting data from different review and original articles on general or specific drug interactions with food. This review gives information about various interactions between different foods and drugs and will help physicians and pharmacists prescribe drugs cautiously with only suitable food supplement to get maximum benefit for the patient. PMID:22043389

  14. Animal Models of Social Contact and Drug Self-Administration

    PubMed Central

    Strickland, Justin C.; Smith, Mark A.

    2015-01-01

    Social learning theories of drug abuse propose that individuals imitate drug use behaviors modeled by social peers, and that these behaviors are selectively reinforced and/or punished depending on group norms. Historically, animal models of social influence have focused on distal factors (i.e., those factors outside the drug-taking context) in drug self-administration studies. Recently, several investigators have developed novel models, or significantly modified existing models, to examine the role of proximal factors (i.e., those factors that are immediately present at the time of drug taking) on measures of drug self-administration. Studies using these newer models have revealed several important conclusions regarding the effects of social learning on drug abuse: 1) the presence of a social partner influences drug self-administration, 2) the behavior of a social partner determines whether social contact will increase or decrease drug intake, and 3) social partners can model and imitate specific patterns of drug self-administration. These findings are congruent with those obtained in the human laboratory, providing support for the cross-species generality and validity of these preclinical models. This mini-review describes in detail some of the preclinical animal models used to study social contact and drug self-administration to guide future research on social learning and drug abuse. PMID:26159089

  15. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. (a)...

  16. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. (a) The...

  17. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  18. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. (a) The...

  19. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. (a)...

  20. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  1. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  2. 21 CFR 1310.10 - Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. 1310.10 Section 1310.10 Food and Drugs DRUG ENFORCEMENT... Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act. (a)...

  3. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  4. Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting "Deadly Medicine" to the test.

    PubMed

    Anderson, J L; Pratt, C M; Waldo, A L; Karagounis, L A

    1997-01-01

    In his book Deadly Medicine and on television, Thomas Moore impugns the process of antiarrhythmic drug approval in the 1980s, alleging that the new generation of drugs had flooded the marketplace and had caused deaths in numbers comparable to lives lost during war. To assess these important public health allegations, we evaluated annual coronary artery disease death rates in relation to antiarrhythmic drug sales (2 independent marketing surveys). Predicted mortality rates were modeled using linear regression analysis for 1982 through 1991. Deviations from predicted linearity were sought in relation to rising and falling class IC and overall class I antiarrhythmic drug use. Flecainide came to market in 1986 and encainide in 1987. Combined class IC sales peaked in 1987 and 1988 (maximum market penetration, 20%, first quarter 1989). Results of the Cardiac Arrhythmia Suppression Trial (CAST) were disclosed in April 1989. Overall annual class I antiarrhythmic prescription sales actually fell slightly (-3% to -4%/yr) in the 2 years before CAST and then more abruptly (- 12%) in the year after CAST (1990). Sales of class IC drugs fell dramatically after CAST (by 75%). Coronary death rates (age adjusted) fell in a linear fashion during the decade of 1982 through 1991. No deviation from predicted rates was observed during the introduction, rise, and fall in class IC (and other class I) sales: rates were 126/100,000 in 1985 (before flecainide), 114 and 110 in 1987 and 1988 (maximum sales), and 103 in 1990 (after CAST). Deviations in death rates in the postulated range of 6,000 to 25,000 per year were shown to be excluded easily by the 95% confidence intervals about the predicted rates. Entry of new antiarrhythmic drugs in the 1980s did not lead to overall market expansion and had no adverse impact on coronary artery disease death rates, which fell progressively. Thus, the allegations in Deadly Medicine could not be confirmed. PMID:9024734

  5. Cholinergic modulation of food and drug satiety and withdrawal

    PubMed Central

    Avena, Nicole M.; Rada, Pedro V.

    2015-01-01

    Although they comprise only a small portion of the neurons in the region, cholinergic interneurons in the dorsal striatum appear to play an important role in the regulation of various appetitive behaviors, in part, through their interactions with mesolimbic dopamine (DA) systems. In this review, we describe studies that suggest that the activity of cholinergic interneurons in the nucleus accumbens (NAc) and cholinergic projections to the ventral tegmental area (VTA) affect feeding behavior. In vivo microdialysis studies in rats have revealed that the cessation of a meal is associated with a rise in acetylcholine (ACh) levels in the NAc. ACh activation will suppress feeding, and this is also associated with an increase in synaptic accumulation of ACh. Further, we discuss how, in addition to their role in the ending of a meal, cholinergic interneurons in the NAc play an integral role in the cessation of drug use. Another cholinergic system involved in different aspects of appetitive behavior is the projection from the pedunculpontine nuclei directly to the VTA. Activation of this system enhances behaviors through activation of the mesolimbic DA system, and antagonism of ACh receptors in the VTA can reduce drug self-administration. Finally, we discuss the role of accumbens ACh in both drug and palatable food withdrawal. Studies reveal that accumbens ACh is increased during withdrawal from several different drugs of abuse (including cocaine, nicotine and morphine). This rise in extracellular levels of ACh, coupled with a decrease in extracellular levels of DA, is believed to contribute to an aversive state, which can manifest as behaviors associated with drug withdrawal. This theory has also been applied to studies of overeating and/or “food addiction,” and the findings suggest a similar imbalance in DA/ACh levels, which is associated with behavioral indications of drug-like withdrawal. In summary, cholinergic neurons play an important role in the modulation of

  6. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT...

  7. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT...

  8. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES...

  9. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES General Provisions §...

  10. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Provisions §...

  11. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions §...

  12. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES General Provisions §...

  13. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Provisions §...

  14. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES...

  15. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions §...

  16. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES General Provisions §...

  17. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC...

  18. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND...

  19. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND...

  20. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  1. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  2. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  3. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  4. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  5. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.9 Limitations...

  6. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 890.9 Section 890.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.9...

  7. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.9 Limitations...

  8. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES General Provisions § 870.9 Limitations...

  9. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General Provisions § 886.9 Limitations...

  10. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions §...

  11. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General Provisions § 882.9 Limitations...

  12. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.9 Limitations...

  13. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.9 Limitations...

  14. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 890.9 Section 890.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES General Provisions § 890.9...

  15. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES General Provisions § 868.9 Limitations...

  16. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.9 Limitations...

  17. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General Provisions § 886.9 Limitations...

  18. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General Provisions § 882.9 Limitations...

  19. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES General Provisions § 870.9 Limitations...

  20. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions §...

  1. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES...

  2. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES...

  3. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES...

  4. PREDICTING DRUG DISPOSITION, ABSORPTION / ELIMINATION / TRANSPORTER INTERPLAY AND THE ROLE OF FOOD ON DRUG ABSORPTION

    PubMed Central

    Custodio, Joseph M.; Wu, Chi-Yuan; Benet, Leslie Z.

    2008-01-01

    The ability to predict drug disposition involves concurrent consideration of many chemical and physiological variables and the effect of food on the rate and extent of availability adds further complexity due to postprandial changes in the gastrointestinal (GI) tract. A system that allows for the assessment of the multivariate interplay occurring following administration of an oral dose, in the presence or absence of meal, would greatly benefit the early stages of drug development. This is particularly true in an era when the majority of new molecular entities are highly permeable, poorly soluble, extensively metabolized compounds (BDDCS Class 2), which present the most complicated relationship in defining the impact of transporters due to the marked effects of transporter-enzyme interplay. This review evaluates the GI luminal environment by taking into account the absorption / transport / elimination interplay and evaluates the physiochemical property issues by taking into account the importance of solubility, permeability and metabolism. We concentrate on the BDDCS and its utility in predicting drug disposition. Furthermore, we focus on the effect of food on the extent of drug availability (F), which appears to follow closely what might be expected if a significant effect of high fat meals is inhibition of transporters. That is, high fat meals and lipidic excipients would be expected to have little effect on F for Class 1 drugs; they would increase F of Class 2 drugs, while decreasing F for Class 3 drugs. PMID:18199522

  5. 76 FR 13880 - Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 314 Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment AGENCY: Food and Drug Administration... amending its investigational new drug application (IND) regulations and abbreviated new drug...

  6. Difficulties experienced during preparation and administration of oral drugs

    PubMed Central

    Boztepe, Handan; Özdemir, Handan; Karababa, Çiğdem; Yıldız, Özlem

    2014-01-01

    Aim: It was aimed to determine the difficulties experienced by pediatric nurses working in the wards of a university hospital during preparation and administration of drugs and to determine solution recommendations. Material and Methods: One hundred and eight nurses who accepted to participate in the study constituted the sample of the study. Open-ended questions were asked in order to obtain detailed information about the attitudes and views of the participants and face to face interview was used. The problems experienced during preparation and administration of drugs were collected using the data collection form prepared by the investigators. Institution approval, ethics committee approval (HEK12/193) and written informed consent from the nurses who wished to participate in the study were obtained to conduct the study. The data obtained were expressed as figures and percentages. Results: The most commonly reported problems in preparation of drugs included incomplete dissolution of tablets or non-homogeneous distribution in fluids (54.6%) and difficulty in breaking tablets in appropriate doses (45.3%). The most commonly reported problem experienced during administration of drugs was rejection of drugs which tasted bad by babies/children or spitting out the drug (75.9%). In our study, the nurses also mentioned the problems related with drug administration equipment. These problems included fear of injectors (25.9%), escape of the drugs into the respiratory way (15.7%) and lack of appropriate equipment for administering the drugs (7.4%). Conclusions: In our study, it was found that all nurses experienced difficulty in preparing and administering drugs. The problems experienced by the nurses and solution recommendations for these problems were reported to the hospital administration. PMID:26078668

  7. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ...; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration...) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C...

  8. Risk assessment principle for engineered nanotechnology in food and drug.

    PubMed

    Hwang, Myungsil; Lee, Eun Ji; Kweon, Se Young; Park, Mi Sun; Jeong, Ji Yoon; Um, Jun Ho; Kim, Sun Ah; Han, Bum Suk; Lee, Kwang Ho; Yoon, Hae Jung

    2012-06-01

    While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment. PMID:24278592

  9. The effects of heroin administration and drug cues on impulsivity.

    PubMed

    Jones, Jermaine D; Vadhan, Nehal P; Luba, Rachel R; Comer, Sandra D

    2016-08-01

    Drug addiction is a chronic relapsing disorder characterized by compulsive drug seeking and continued use despite negative consequences. Behavioral impulsivity is a strong predictor of the initiation and maintenance of drug addiction. Preclinical data suggest that heroin may exacerbate impulsive characteristics in an individual but this has yet to be assessed in clinical samples. The current secondary data analysis sought to investigate the effects of heroin on impulsivity along with the effects of exposure to drug cues. Using the current data set, we also tentatively assessed the etiological relationship between impulsivity and heroin abuse. Sixteen heroin-dependent participants were recruited to complete Immediate Memory Task/Delayed Memory Task (IMT/DMT) and GoStop tasks following repeated heroin administration, following acute heroin administration, and following a drug cue exposure session. Four preceding days of active heroin availability, compared to four preceding days of placebo drug availability, increased impulsivity assessed using the IMT and DMT. Presentation of drug cues similarly acted to increase impulsivity assessments on all three tasks. It also appears that heavier users were more susceptible to the influence of drug cues on impulsivity. The present study represents a step toward a more comprehensive understanding of the interaction between opioid abuse and impulsivity. A better understanding of these factors could provide critical insight into the maintenance of heroin use and relapse. PMID:27062912

  10. Just a Spoonful of Sugar Will Land You Six Feet Underground: Should the Food and Drug Administration Revoke Added Sugar's GRAS Status?

    PubMed

    Card, Melissa Marie; Abela, John Francis

    2015-01-01

    This article assesses whether added sugar meets FDA's standard to be generally recognized as safe ("GRAS"). If added sugar is not GRAS, then manufacturers are subject to premarket approval prior to using added sugar in their products. This article advocates that FDA should issue a Federal Register notice determining that added sugar is not GRAS, allowing FDA to regulate the amount of added sugar used in processed foods, decreasing the health adversities that stem from added sugar consumption. PMID:26630822

  11. Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

    PubMed

    Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

    2013-03-01

    Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs. PMID:23678729

  12. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 320 (formerly Docket No. 00N-1484) RIN...: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA... products: Janet Norden, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

  13. 21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.20 Conditions for permitted extralabel animal and human drug use in...

  14. 21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.20 Conditions for permitted extralabel animal and human drug use in...

  15. 21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.20 Conditions for permitted extralabel animal and human drug use in...

  16. 21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.20 Conditions for permitted extralabel animal and human drug use in...

  17. 21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.20 Conditions for permitted extralabel animal and human drug use in...

  18. Registering medicines for low-income countries: how suitable are the stringent review procedures of the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency?

    PubMed

    Doua, Joachim Y; Van Geertruyden, Jean-Pierre

    2014-01-01

    New medicines are registered after a resource-demanding process. Unfortunately, in low-income countries (LICs), demand outweighs resources. To facilitate registration in LICs, stringent review procedures of the European Medicines Agency (EMA Article-58), Food and Drug Administration (FDA PEPFAR-linked review) and WHO Prequalification programme have been established. Only the PEPFAR-linked review gives approval, while the others make recommendations for approval. This study assessed the performance and discussed the challenges of these three stringent review procedures. Data from WHO, FDA, EMA, Medline and Internet were analysed. Over 60% of medicines reviewed by stringent review procedures are manufactured in India. Until 2012, WHO prequalified 400 medicines (211 vaccines, 130 antiretrovirals, 29 tuberculostatics, 15 antimalarials and 15 others). PEPFAR-linked review approved 156 antiretrovirals, while EMA Article 58 recommended approval of 3 antiretrovirals, 1 vaccine and 1 antimalarial. WHO Prequalification and PEPFAR-linked review are free of charge and as a result have accelerated access to antiretrovirals. They both built capacity in sub-Saharan Africa, although WHO prequalification relies technically on stringent regulatory authorities and financially on donors. Article-58 offers the largest disease coverage and strongest technical capacities, is costly and involves fewer LICs. To meet the high demand for quality medicines in LICs, these stringent review procedures need to enlarge their disease coverage. To improve registration, EMA Article 58 should actively involve LICs. Furthermore, LIC regulatory activities must not be fully resigned to stringent review procedure. PMID:24134396

  19. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug... 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request,...

  20. Behavioral economics of drug self-administration and drug abuse policy.

    PubMed Central

    Hursh, S R

    1991-01-01

    The concepts of behavioral economics have proven useful for understanding the environmental control of overall levels of responding for a variety of commodities, including reinforcement by drug self-administration. These general concepts are summarized for application to the analysis of drug-reinforced behavior and proposed as the basis for future applications. This behavioral agenda includes the assessment of abuse liability, the assay of drug-reinforcer interactions, the design of drug abuse interventions, and the formulation of drug abuse public policy. These separate domains of investigation are described as part of an overall strategy for designing model projects to control drug use and testing public policy initiatives. PMID:1955823