Science.gov

Sample records for drug administration advisory

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

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

  2. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

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

  3. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

    PubMed

    Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

    2014-10-01

    Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

  4. Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting regarding cangrelor.

    PubMed

    Lhermusier, Thibault; Baker, Nevin C; Waksman, Ron

    2015-04-15

    Landmark clinical trials have established the benefit of P2Y12 inhibitors in the setting of acute coronary syndrome and percutaneous coronary intervention. On February 12, 2014, the Medicines Company (Sponsor) presented efficacy and safety data regarding cangrelor to the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee. The Sponsor sought approval for 2 indications: (1) in the setting of percutaneous coronary intervention for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with coronary artery disease and (2) in the setting of bridging therapy in patients with acute coronary syndrome or with stents who are at increased risk for thrombotic events (such as stent thrombosis) when oral P2Y12 therapy is interrupted because of surgery. The following is a summary of the data presented to the FDA by the Sponsor, the FDA's clinical review of cangrelor.

  5. 76 FR 25357 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee; Medical Imaging Drugs Advisory Committee... Administration (FDA) is announcing the ] reestablishment of the Medical Imaging Drugs Advisory Committee in the.... 101-635); and 21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical Imaging...

  6. 77 FR 37414 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

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

  7. 75 FR 47309 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

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

  8. 77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

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

  9. 77 FR 7587 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of...

  10. 77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

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

  11. 76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

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

  12. 78 FR 13349 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

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

  13. 76 FR 65736 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

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

  14. 77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

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

  15. 76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

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

  16. 75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

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

  17. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

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

  18. 75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

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

  19. 77 FR 17078 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

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

  20. 78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

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

  1. 76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

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

  2. 76 FR 32220 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

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

  3. 76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

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

  4. 77 FR 49446 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

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

  5. 76 FR 14027 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

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

  6. 76 FR 14026 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

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

  7. 75 FR 64314 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-19

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

  8. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee was... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs...

  9. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Medical Imaging Drugs.... SUMMARY: The Food and Drug Administration (FDA) is announcing the re- establishment of the Medical Imaging... language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing...

  10. 76 FR 35451 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

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

  11. 76 FR 59142 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive... of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of...

  12. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. ] Name of Committee: Cardiovascular and Renal Drugs Advisory Committee....

  13. 77 FR 49447 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee... be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory...

  14. 78 FR 50423 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee... be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory...

  15. 77 FR 63840 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee... be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory...

  16. 77 FR 6567 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee... be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory...

  17. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... Cardiovascular and Renal Drugs Advisory Committee scheduled for September 14, 2012, is cancelled. The meeting is no longer needed. This meeting was announced in the Federal Register of July 23, 2012 (77 FR 43093... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory...

  18. 75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... October 19, 2010 (75 FR 64314), FDA announced that a meeting of the Oncologic Drugs Advisory Committee... meeting was announced in the Federal Register of October 19, 2010 (75 FR 64314). The amendment is being... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of...

  19. 77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... announced in the Federal Register of May 31, 2012 (77 FR 32125-32126). The amendment is being made to... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA)...

  20. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... Committee; Medical Imaging Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION... on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research. FDA... requesting nominations for voting members on the Medical Imaging Drugs Advisory Committee (the...

  1. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... September 20, 2012 (77 FR 58399). The issues for which the FDA was seeking the scientific input of the... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs...

  2. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice..., 2012, Drug Safety and Risk Management Advisory Committee meeting due to unanticipated weather conditions caused by Hurricane Sandy. Name of Committee: Drug Safety and Risk Management Advisory...

  3. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  4. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  5. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  6. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Establishment of standing technical advisory committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription...

  7. 78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting...

  8. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ... HUMAN SERVICES Food and Drug Administration Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  9. 75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  10. 78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  11. 77 FR 6804 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  12. 75 FR 5333 - Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... was announced in the Federal Register of January 19, 2010 (75 FR 2875). This meeting has been... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of...

  13. 75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new... HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of...

  14. 77 FR 27072 - Gastrointestinal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ... Federal Register of March 23, 2012 (77 FR 17078). The meeting is being canceled because the Agency no... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the...

  15. 75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... meeting originally announced in the Federal Register of December 17, 2009 (74 FR 66986) to take place on... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of...

  16. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm....

  17. 77 FR 64346 - Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... Administration (FDA) is announcing an amendment to the notice of meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 10, 2012 (77 FR... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory...

  18. 77 FR 55845 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

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

  19. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... Administration (FDA) is announcing an amendment to the notice of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the Federal Register of February 2, 2010 (75 FR 5334... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Amendment...

  20. 76 FR 19374 - Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Cardiovascular and Renal Drugs Advisory.... Name of Committees: Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and...

  1. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management...

  2. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug...

  3. 75 FR 81618 - Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... HUMAN SERVICES Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Anesthetic and Life Support Drugs Advisory Committee... degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results...

  4. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive... of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... break loose and move within the circulatory system) associated with use of these products may be...

  5. 77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of the... sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis in patients aged...

  6. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... pulmonary fibrosis (scarring of the lungs without a known cause) to decrease the decline in lung function... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  7. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  8. 75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  9. 75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  10. 75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  11. 76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  12. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  13. 77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  14. 75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  15. 78 FR 29142 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory...

  16. 77 FR 67380 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory...

  17. 75 FR 39032 - Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES> Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee... be open to the public. Name of Committee: Anesthetic and Life Support Drugs Advisory...

  18. 78 FR 27405 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory...

  19. 75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ... patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. FDA... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  20. 77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  1. 78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. FDA intends to... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  2. 77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  3. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. FDA intends to make... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  4. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ... patients with chronic obstructive pulmonary disease. FDA intends to make background material available to... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of..., Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name...

  5. 75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  6. 77 FR 59196 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-26

    ... HUMAN SERVICES Food and Drug Administration Anti-Infective Drugs Advisory Committee; Notice of Meeting... about last minute modifications that impact a previously announced advisory committee meeting cannot... multi-drug resistant pulmonary tuberculosis. FDA intends to make background material available to...

  7. 75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  8. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

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

  9. 78 FR 48690 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting...

  10. 75 FR 876 - Anesthetic and Life Support Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... was announced in the Federal Register of December 8, 2009 (74 FR 64702). This meeting has been... HUMAN SERVICES Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the...

  11. 78 FR 42088 - Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... was announced in the Federal Register of May 17, 2013 (78 FR 29142 to 29143). This meeting has been... HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the...

  12. 75 FR 32188 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... public. Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety...

  13. 75 FR 59730 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... public. Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety...

  14. 75 FR 12767 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... public. Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety...

  15. 75 FR 67093 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... will be closed to the public. Name of Committees: Anesthetic and Life Support Drugs Advisory...

  16. 75 FR 47821 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ..., double- blind, placebo-controlled trial, which is a kind of clinical trial designed to provide data with...; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee ] of the Food and Drug Administration (FDA). The...

  17. 75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Cardiovascular and Renal Drugs...

  18. 77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Cardiovascular and Renal Drugs...

  19. Drug Enforcement Administration.

    ERIC Educational Resources Information Center

    Department of Justice, Washington, DC.

    This fact sheet contains information relating to drug abuse and abusers; drug traffic legislation; law enforcement; and descriptions of commonly used narcotics, stimulants, depressants, and hallucinogens. Also included is a short but explicit listing of audiovisual aids, an annotated bibliography, and drug identification pictures. The booklet…

  20. 75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Peripheral and Central Nervous System... the public. Name of Committees: Peripheral and Central Nervous System Drugs Advisory Committee and...

  1. 76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-17

    ... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm... appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will be asked to comment on the following topics related to the use...

  2. 78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  3. 77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  4. 75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  5. 76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  6. 75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  7. 78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  8. 78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  9. 75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  10. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... (proposed trade name Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice...

  11. 75 FR 71188 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The... electronic tax administration issues in support of the overriding goal that paperless filing should be...

  12. 75 FR 30109 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The... electronic tax administration issues in support of the overriding goal that paperless filing should be...

  13. 78 FR 32306 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-29

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Electronic Tax Administration Advisory Committee (ETAAC) will be conducted via telephone conference call. The ETAAC will discuss recommendations for electronic tax administration which will be published in...

  14. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Drug Safety and Risk Management... public. Name of Committees: Drug Safety and Risk Management Advisory Committee and Dermatologic and... (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation...

  15. 77 FR 70879 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The primary purpose of ETAAC is to provide an organized public forum for discussion of electronic...

  16. 76 FR 30434 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The primary purpose of ETAAC is to provide an organized public forum for discussion of electronic...

  17. 76 FR 6186 - Applications for Membership on the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... Internal Revenue Service Applications for Membership on the Electronic Tax Administration Advisory... membership on the Electronic Tax Administration Advisory Committee (ETAAC). Nominations of qualified... II of the application and include recent examples of specific expertise in e- file security,...

  18. Drugs and drug administration in extreme environments.

    PubMed

    Küpper, Thomas E A H; Schraut, Bettina; Rieke, Burkhard; Hemmerling, Arnica-Verena; Schöffl, Volker; Steffgen, Juergen

    2006-01-01

    Emergency medicine must often cope with harsh climates far below freezing point or high temperatures, and sometimes, an alternative to the normal route of drug administration is necessary. Most of this information is not yet published. Therefore, we summarized the information about these topics for most drugs used in medical emergencies by combining literature research with extensive personal communications with the heads of the drug safety departments of the companies producing these drugs. Most drugs can be used after temperature stress of limited duration. Nevertheless, we recommend replacing them at least once per year or after extreme heat. Knowledge about drugs used in extreme environments will be of increasing importance for medical personnel because in an increasingly mobile society, more and more people, and especially elderly -often with individual medical risks-travel to extreme regions such as tropical or arctic regions or to high altitude, and some of them need medical care during these activities. Because of this increasing need to use drugs in harsh climates (tourism, expeditions, peace corps, military, etc) the actual International Congress of Harmonization recommendations should be added with stability tests at +50 degrees C, freezing and oscillating temperatures, and UV exposure to simulate the storage of the drugs at "outdoor conditions." PMID:16412107

  19. 76 FR 36930 - National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... HUMAN SERVICES National Institutes of Health National Advisory Council on Alcohol Abuse and Alcoholism... the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse... Committee: National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on...

  20. 78 FR 37821 - Joint Meeting of the Risk Communication Advisory Committee and Tobacco Products Scientific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ...: Risk Communication Advisory Committee and Tobacco Products Scientific Advisory Committee. General... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Risk Communication Advisory Committee and Tobacco Products Scientific Advisory Committee; Notice of Joint Meeting AGENCY: Food and...

  1. 78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... Health Drugs and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food... Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register... the Drug Safety and Risk Management Advisory Committee would be held on April 18, 2013. On page...

  2. 78 FR 16271 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-14

    ... Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food... of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations...

  3. 78 FR 34384 - The President's Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ... ADMINISTRATION The President's Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The President's Commission on Election Administration (PCEA), a Federal...

  4. 78 FR 52531 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The Presidential Commission on Election Administration (PCEA), a Federal...

  5. 78 FR 35272 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: M eeting notice. SUMMARY: The Presidential Commission on Election Administration (PCEA), a Federal...

  6. 78 FR 38042 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting; Correction AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice; correction. SUMMARY: The Presidential Commission on Election Administration (PCEA),...

  7. 78 FR 55079 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meetings AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice. SUMMARY: The Presidential Commission on Election Administration (PCEA), a Federal...

  8. 78 FR 45200 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-26

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The Presidential Commission on Election Administration (PCEA), a Federal...

  9. 78 FR 69416 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting AGENCY: Office of Government-Wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting Notice. SUMMARY: The Presidential Commission on Election Administration (PCEA), a Federal...

  10. 78 FR 64957 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Joint Meeting AGENCY: Food... public. Name of Committees: Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations...

  11. 77 FR 67013 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... links: December 4, 2012: Blood Products Advisory Committee Day 1:...

  12. 76 FR 39405 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... available at the following links. Blood Products Advisory Committee Day 1:...

  13. 78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Risk Communications Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communications Advisory Committee. General Function of the... the free Webcast. Visit the Risk Communication Advisory Committee Web site at...

  14. 76 FR 12793 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC).The... electronic tax administration issues in support of the overriding goal that paperless filing should be...

  15. 76 FR 37131 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and... and Risk Management Advisory Committee. General Function of the Committees: To provide advice...

  16. 77 FR 31441 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-25

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC).The primary purpose of ETAAC is to provide an organized public forum for discussion of electronic...

  17. 76 FR 64428 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC).The primary purpose of ETAAC is to provide an organized public forum for discussion of electronic...

  18. 75 FR 76993 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  19. 75 FR 56547 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  20. 76 FR 38667 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory Committee... be open to the public. Name of Committee: Transmissible Spongiform Encephalopathies Advisory... available at the following link. Transmissible Spongiform Encephalopathies Advisory Committee...

  1. 78 FR 44132 - Food Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... HUMAN SERVICES Food and Drug Administration Food Advisory Committee; Notice of Meeting AGENCY: Food and... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food Advisory Committee. General Function of the Committee: To provide advice...

  2. 75 FR 74735 - Food Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... HUMAN SERVICES Food and Drug Administration Food Advisory Committee; Notice of Meeting AGENCY: Food and... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food Advisory Committee. General Function of the Committee: To provide advice...

  3. 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:...

  4. 77 FR 4567 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

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

  5. 76 FR 59406 - Allergenic Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

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

  6. 75 FR 24773 - Research and Innovative Technology Administration Advisory Council on Transportation Statistics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... Bureau of Transportation Statistics Research and Innovative Technology Administration Advisory Council on Transportation Statistics; Notice of Meeting AGENCY: Research and Innovative Technology Administration, U.S... U.S. Mail to: U.S. Department of Transportation, Research and Innovative Technology...

  7. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Standards advisory committees. 861.38 Section 861.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration...

  8. 76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... November 18, 2011, the committee will discuss implications, for strategic communication, of...

  9. 77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... Campus must enter through Building 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff,...

  10. 76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... work, as discussed in previous meetings, by current and former members of the Risk...

  11. 75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-20

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... programs, such as FDA's Strategic Plan for Risk Communication, FDA's Transparency Initiative, and...

  12. 76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of...

  13. 75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of...

  14. 77 FR 31025 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... enter through Building 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff, Office of...

  15. 78 FR 17414 - Risk Communications Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ... HUMAN SERVICES Food and Drug Administration Risk Communications Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communications Advisory Committee. General Function of the...: Luis G. Bravo, Designated Federal Officer, Risk Communication Staff, Office of Planning, Food and...

  16. 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...

  17. 77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ....fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting... Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome. FDA... available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll down to the...

  18. 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...

  19. 75 FR 17829 - Motorcyclist Advisory Council to the Federal Highway Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-07

    ... a notice of intent to form an advisory committee in the Federal Register on December 23, 2005 (70 FR... to the Council in the Federal Register on October 5, 2006 (71 FR 58903). An electronic copy of this... Administration (MAC-FHWA). The purpose of this meeting is to advise the Secretary of Transportation, through...

  20. 75 FR 47523 - Assembly of the Administrative Conference; Filing of Advisory Committee Charter

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Conference Act (as amended by the Regulatory Improvement Act of 2007) and the Federal Advisory Committee Act... purpose of the Assembly is to adopt recommendations for the improvement of administrative procedures in... Improvement Act of 2007, Public Law 110-290, codified at 5 U.S.C. 596 (authorizing appropriations for...

  1. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond... . Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present...

  2. 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.

  3. 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...

  4. 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...

  5. 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...

  6. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.140 Establishment of a color...

  7. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Functions of a color additive advisory committee. 14.142 Section 14.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.142 Functions of a color additive...

  8. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees §...

  9. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedures of a color additive advisory committee. 14.145 Section 14.145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees §...

  10. 21 CFR 14.145 - Procedures of a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Procedures of a color additive advisory committee. 14.145 Section 14.145 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.145 Procedures of a color additive...

  11. 21 CFR 14.142 - Functions of a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Functions of a color additive advisory committee. 14.142 Section 14.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees §...

  12. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.155 Fees...

  13. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color Additive Advisory Committees § 14.140 Establishment of a color...

  14. Exploring network theory for mass drug administration.

    PubMed

    Chami, Goylette F; Molyneux, David H; Kontoleon, Andreas A; Dunne, David W

    2013-08-01

    Network theory is a well-established discipline that uses mathematical graphs to describe biological, physical, and social systems. The topologies across empirical networks display strikingly similar organizational properties. In particular, the characteristics of these networks allow computational analysis to contribute data unattainable from examining individual components in isolation. However, the interdisciplinary and quantitative nature of network analysis has yet to be exploited by public health initiatives to distribute preventive chemotherapies. One notable application is the 2012 World Health Organization (WHO) Roadmap for Neglected Tropical Diseases (NTDs) where there is a need to upscale distribution capacity and to target systematic noncompliers. An understanding of local networks for analysing the distributional properties of community-directed treatment may facilitate sustainable expansion of mass drug-administration (MDA) programs.

  15. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  16. 76 FR 38188 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  17. 77 FR 10755 - Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for members to serve...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY:...

  19. 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

  20. 78 FR 56900 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ...), manufactured by Gilead Sciences, Inc., with a proposed indication for the treatment of chronic hepatitis C... given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 10, 2013....

  1. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... syndrome with diarrhea. FDA intends to make background material available to the public no later than 2.... Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll...

  2. 75 FR 65640 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and... Tumor Vaccines and Biotechnology Branch, Office of Cellular, Tissue and Gene Therapies, Center...

  3. 77 FR 73472 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice...

  4. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Device Good Manufacturing Practice Advisory Committee... meeting will be open to the public. Name of Committee: Device Good Manufacturing Practice Advisory... effects of extreme weather and natural disasters on medical device manufacturing chain processes...

  5. 77 FR 44639 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-30

    ... HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Advisory Committee. General Function of the Committee: To provide advice and... Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154,...

  6. 77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

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

  7. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... HUMAN SERVICES Food and Drug Administration Veterinary Medicine Advisory Committee; Notice of Meeting... the public. Name of Committee: Veterinary Medicine Advisory Committee. General Function of the... Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9004,...

  8. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

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

  9. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

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

  10. 75 FR 66381 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Advisory Committee. General Function of the Committee: To provide advice and... to the Agency on the issues before the Pediatric Advisory Committee. Submit either electronic...

  11. 78 FR 12763 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Advisory Committee. General Function of the Committee: To provide advice and... Thursday, March 14, 2013, the Pediatric Advisory Committee will meet to discuss pediatric-focused...

  12. 75 FR 26265 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Advisory Committee. General Function of the Committee: To provide advice and... meeting. Agenda: On Monday, June 21, the Pediatric Advisory Committee will meet to discuss...

  13. 75 FR 35494 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... Services Advisory Committee on Blood Safety and Availability; December 14 and 15, 2009, FDA workshop...

  14. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... established on April 24, 1984 (49 FR 20809; May 17, 1984). The purpose of the Committee was to review and... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Veterinary Medicine... Food and Drug Administration (FDA) is announcing the termination of the Veterinary Medicine...

  15. 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...

  16. A review of human drug self-administration procedures

    PubMed Central

    Jones, Jermaine D.; Comer, Sandra D.

    2014-01-01

    Drug self-administration procedures in laboratory settings allow us to closely model drug-taking behavior in real-world settings. This review provides an overview of many of the common self-administration methods used in human laboratory research. Typically, self-administration studies provide a quantifiable measure of the reinforcing effect of a drug, which is believed to be predictive of its potential for abuse. Several adaptations of the self-administration paradigm exist, the simplest of which allows participants free access to the drug under investigation. Free-access procedures allow investigators to observe patterns of drug self-administration and drug effects in a controlled setting. Allowing participants to choose between two simultaneously available reinforcers (choice procedures) is another well-established method of assessing the reinforcing effects of a drug. Offering a choice between two reinforcers (e.g. two different doses of the same drug, two different drugs, or drug and nondrug reinforcers) provides researchers with a point of comparison (e.g. between a drug of known abuse potential and a novel drug). When combined with other endpoints, such as subjective effects ratings, physiological responses, and cognitive performance, human self-administration paradigms have contributed significantly to our understanding of the factors that contribute to, maintain, and alter drug-taking behavior including: craving, positive subjective effects, toxicity, drug interactions and abstinence. This area of research has also begun to incorporate other techniques such as imaging and genetics to further understand the multifaceted nature of substance abuse. The present paper summarizes the different self-administration techniques that are commonly used today and the application of other procedures that may complement interpretation of the drug PMID:23839027

  17. Animal models of social contact and drug self-administration.

    PubMed

    Strickland, Justin C; Smith, Mark A

    2015-09-01

    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.

  18. 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

  19. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... to 45 CFR part 11 and by the General Services Administration. (b) When an advisory committee...

  20. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... to 45 CFR part 11 and by the General Services Administration. (b) When an advisory committee...

  1. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... to 45 CFR part 11 and by the General Services Administration. (b) When an advisory committee...

  2. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... to 45 CFR part 11 and by the General Services Administration. (b) When an advisory committee...

  3. 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

  4. 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

  5. Drugs on the College Campus. A Guide for College Administrators.

    ERIC Educational Resources Information Center

    Nowlis, Helen H.

    This guide to drugs on the college campus provides accurate information to help administrators and other college officials understand and cope with the use of drugs by college students. The problem is defined, and facts about drugs, and the implications and issues occasioned by their use, are presented. Information is also offered in the following…

  6. 78 FR 13072 - Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

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

  7. 21 CFR 20.29 - Prohibition on withdrawal of records from Food and Drug Administration files.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 to the Food and Drug Administration. All Food and Drug Administration records shall be retained by...

  8. 78 FR 70946 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established in... Management Advisory Board, Office of Executive Councils, General Services Administration, 1800 F Street...

  9. 77 FR 38065 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established in..., President's Management Advisory Board, Office of Executive Councils, General Services Administration, 1776...

  10. 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.''...

  11. THE AGRICULTURAL ADVISORY BOARD, A HANDBOOK FOR BOARDS OF EDUCATION, SCHOOL ADMINISTRATORS ADVISORY BOARD MEMBERS AND TEACHERS OF AGRICULTURE.

    ERIC Educational Resources Information Center

    CUSHMAN, HAROLD R.

    THE PURPOSE OF THIS HANDBOOK IS TO ASSIST EDUCATIONAL PERSONNEL IN MAKING THE MOST EFFECTIVE USE OF AGRICULTURAL ADVISORY BOARDS IN THE ORGANIZATION AND DEVELOPMENT OF LOCAL VOCATIONAL AGRICULTURE PROGRAMS. IT CONTAINS INFORMATION ON (1) PROCEDURES FOR FORMING NEW AGRICULTURAL ADVISORY BOARDS OR REORGANIZING OLD ONES INCLUDING WHERE TO START, WHO…

  12. The Food and Drug Administration and medroxyprogesterone acetate. What are the issues?

    PubMed

    Rosenfield, A; Maine, D; Rochat, R; Shelton, J; Hatcher, R A

    1983-06-01

    In 1978, the Food and Drug Administration denied approval of the three-month injectable contraceptive depot medroxyprogesterone acetate for use in the United States. This decision goes against the advice of the FDA's own scientific advisory panels, as well as the rulings of the World Health Organization and the drug regulation institutions of more than 70 developed and developing countries. In response to protest from the manufacturer of depot medroxyprogesterone acetate and from many health professionals, the FDA took the unusual step of scheduling a public board of inquiry to review its decision in January 1983. Reviewing the scientific literature on the risks and benefits of depot medroxyprogesterone acetate, we find no reason to deny depot medroxyprogesterone acetate approval, provided that studies of its possible side effects are continued and that women use it only after having made an informed choice between this and other methods of contraception.

  13. 75 FR 70932 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... FR 67093). This meeting has been cancelled because the Agency believes the information received from... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Joint Meeting of the Anesthetic and...

  14. 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...

  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. 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.

  17. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... Management Advisory Committee. This meeting was announced in the Federal Register of March 8, 2010 (75 FR... drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis....

  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. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  20. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  1. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  2. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  3. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  4. 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

  5. 78 FR 44574 - Third Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

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

  6. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance and Enforcement Data; Availability AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice...

  9. 78 FR 11655 - Neonatal Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... HUMAN SERVICES Food and Drug Administration Neonatal Subcommittee of the Pediatric Advisory Committee... be open to the public. Name of Committee: Neonatal Subcommittee of the Pediatric Advisory Committee... Food and Drug Administration Safety and Innovation Act identified the need to expand current...

  10. 76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-29

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  11. 75 FR 57967 - Science Advisory Board to the National Center for Toxicological Research Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory...

  12. 77 FR 57569 - Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-18

    ... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory...

  13. 76 FR 72422 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1...

  14. 76 FR 6626 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  15. 75 FR 28027 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. Function of the..., Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  16. 78 FR 20927 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  17. 75 FR 36660 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  18. 75 FR 22145 - Health Resources and Services Administration (HRSA); CDC/HRSA Advisory Committee on HIV and STD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... (HRSA); CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment (CHACHSPT) In accordance... the Administrator, HRSA, regarding activities related to the prevention and control of HIV/AIDS and other STDs, the support of healthcare services to persons living with HIV/AIDS, and the education...

  19. 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...

  20. 76 FR 12972 - Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the... regarding their request to speak by April 26, 2011. FDA will work with sponsors of acetaminophen...

  1. 78 FR 64505 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration... voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial...

  2. 77 FR 61007 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-05

    ... Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration... voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial...

  3. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Administration records. (a) The Food and Drug Administration will make the fullest possible disclosure of records... 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Administration records. (a) The Food and Drug Administration will make the fullest possible disclosure of records... 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...

  5. 76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... for the development of drugs intended to treat variola virus infection (smallpox) in the event of an... smallpox) as potential evidence of efficacy. FDA intends to make background material available to...

  6. Formulation approaches in mitigating toxicity of orally administrated drugs.

    PubMed

    Kadiyala, Irina; Tan, Elijah

    2013-01-01

    This paper provides an overview of current formulation approaches to mitigate toxicity of orally administrated drugs. The formulation approaches are characterized by their intended impact on a drug's pharmacokinetic parameters, pharmacological properties or metabolic pathways. Regulatory opportunities and constraints with focus on U.S. regulations in optimizing a drug's safety or efficacy profile are reviewed. The following formulation approaches are described: (i) pharmacokinetic-modulating and (ii) pharmacodynamic-modulating. In the pharmacokinetic-modulating approach, the pharmacokinetic profile of drug release is modified by, for example, a reduction in peak drug plasma concentration while preserving or improving AUC, thereby potentially reducing toxic effects that may be related to C(max). In the pharmacodynamic-modulating approach, the drug is co-dosed with pharmacologically active or nonpharmacologically active agent or agents intended for mitigation of the drug's toxicity. The pharmacodynamic-modulating approach requires information on the specificity of drug interactions with other compounds and also on metabolic pathways. Examples demonstrating successful formulation work in reducing drug toxicity are provided. The in-depth knowledge of the drug's PK and PD properties combined with a greater understanding of the biology of diseases are necessary for successful drug product formulation leading to optimized in vivo exposure and minimized toxicity.

  7. 21 CFR 70.51 - Advisory committee on the applicability of the anticancer clause.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Advisory committee on the applicability of the anticancer clause. 70.51 Section 70.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.51 Advisory committee on the...

  8. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Color...

  9. 78 FR 40144 - Governmentwide Travel Advisory Committee (GTAC); Upcoming Public Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... ADMINISTRATION Governmentwide Travel Advisory Committee (GTAC); Upcoming Public Advisory Committee Meeting AGENCY... Governmentwide Travel Advisory Committee (GTAC) (the Committee), is a Federal Advisory Committee established in..., Designated Federal Officer (DFO), Governmentwide Travel Advisory Committee (GTAC), Office of...

  10. 76 FR 65511 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established in... Officer, President's Management Advisory Board, Office of Executive Councils, General...

  11. 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

  12. OxyContin: Prescription Drug Abuse. CSAT Advisory.

    ERIC Educational Resources Information Center

    Substance Abuse and Mental Health Services Administration (DHHS/PHS), Rockville, MD. Center for Substance Abuse Treatment.

    Recently, the media have issued numerous reports about the apparent increase in OxyContin abuse and addiction. OxyContin has been heralded as a miracle drug that allows patients with chronic pain to resume a normal life. It has also been called pharmaceutical heroin and is thought to have been responsible for a number of deaths and robberies in…

  13. 76 FR 1181 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...) GlaxoSmithKline, indicated for the treatment of patients with varieties of non-Hodgkin's lymphoma known...'s lymphoma, who have not received the drug Rituximab; (3) NDA 21-673, tradename CLOLAR (clofarabine... provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The...

  14. 75 FR 30045 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... cancer known as HER2-negative breast cancer, in combination with the chemotherapy drug docetaxel; and (2) first-line treatment of HER2-negative metastatic breast cancer in combination with one of two classes of... for their locally recurrent or metastatic HER2 negative breast cancer. FDA intends to make...

  15. 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

  16. 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.

  17. 21 CFR 808.5 - Advisory opinions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Advisory opinions. 808.5 Section 808.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions §...

  18. 21 CFR 808.5 - Advisory opinions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Advisory opinions. 808.5 Section 808.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions §...

  19. 21 CFR 808.5 - Advisory opinions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Advisory opinions. 808.5 Section 808.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions §...

  20. 21 CFR 808.5 - Advisory opinions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Advisory opinions. 808.5 Section 808.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions §...

  1. 21 CFR 808.5 - Advisory opinions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Advisory opinions. 808.5 Section 808.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions §...

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  3. Early lessons from schistosomiasis mass drug administration programs

    PubMed Central

    Secor, W. Evan

    2015-01-01

    Mass drug administration using praziquantel is the backbone of the current strategy for the control of schistosomiasis. As the theoretical plans have moved into practical application, certain challenges with this approach have surfaced, and it is likely that annual mass drug administration alone may not be sufficient to achieve program goals. However, mass drug administration is still the only available intervention that can be readily used in the wide variety of settings where schistosomiasis is endemic. The task then becomes how to improve this approach and identify what adjuncts to mass drug administration are effective, as programs move from morbidity control to elimination goals. Other aspects worthy of consideration include how best to employ new diagnostic tools to more easily identify where treatment is needed, and new formulations of praziquantel to extend the availability of treatment to all age groups. The aim of this review is to highlight both areas of challenge and of opportunity to improve the public health impact of schistosomiasis control programs. PMID:26937275

  4. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

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

  5. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

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

  6. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

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

  7. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

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

  8. 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 Medical Device 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...

  9. 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; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA) is soliciting comments from interested persons on ways...

  10. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

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

  11. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

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

  12. 78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration... revised and is being reissued for comment because the Food and Drug Administration Safety and...

  13. 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

    ... 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, HHS. ACTION: Notice of public conference. The Food and...

  14. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

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

    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 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 Food and Drug Administration Conflict of...

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

    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 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 Food and Drug Administration Conflict of...

  17. 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...

  18. 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)...

  19. 75 FR 1396 - The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... HUMAN SERVICES Food and Drug Administration The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  20. 75 FR 67378 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-02

    ...), Gardasil (human papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), Lamictal and... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY:...

  1. 78 FR 49272 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... to discuss Cervarix (human papillomavirus Bivalent (Types 16 and 18) vaccine); Gammagard Liquid (Immune Globulin Infusion (human)); Hemacord (hematopoietic progenitor cells, cord blood); Copegus and... HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY:...

  2. 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...

  3. Orbitofrontal response to drug-related stimuli after heroin administration.

    PubMed

    Walter, Marc; Denier, Niklaus; Gerber, Hana; Schmid, Otto; Lanz, Christian; Brenneisen, Rudolf; Riecher-Rössler, Anita; Wiesbeck, Gerhard A; Scheffler, Klaus; Seifritz, Erich; McGuire, Philip; Fusar-Poli, Paolo; Borgwardt, Stefan

    2015-05-01

    The compulsion to seek and use heroin is frequently driven by stress and craving during drug-cue exposure. Although previous neuroimaging studies have indicated that craving is mediated by increased prefrontal cortex activity, it remains unknown how heroin administration modulates the prefrontal cortex response. This study examines the acute effects of heroin on brain function in heroin-maintained patients. Using a crossover, double-blind, placebo-controlled design, 27 heroin-maintained patients performed functional magnetic resonance imaging 20 minutes after the administration of heroin or placebo (saline) while drug-related and neutral stimuli were presented. Images were processed and analysed with statistical parametric mapping. Plasma concentrations of heroin and its main metabolites were assessed using high-performance liquid chromatography. Region of interest analyses showed a drug-related cue-associated blood-oxygen-level-dependent activation in the orbitofrontal cortex (OFC) in heroin-dependent patients during both treatment conditions (heroin and placebo). This activation of the OFC was significantly higher after heroin than after placebo administration. These findings may indicate the importance of OFC activity for impulse control and decision-making after regular heroin administration and may emphasize the benefit of the heroin-assisted treatment in heroin dependence.

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

    PubMed

    Hodel, D

    1995-06-01

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

  5. Discovering the Regulatory Considerations of the Federal Aviation Administration: Interviewing the Aviation Rulemaking Advisory Committee

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsung

    2005-01-01

    Maintenance Resource Management (MRM) training for aviation mechanics has become mandatory in many industrialized countries since 1998. Yet, to date, MRM training remains optional in the U.S. Interestingly, a similar safety discipline, namely Crew/Cockpit Resource Management (CRM), is mandatory for pilots, flight engineers, flight attendants, and dispatchers and is regulated in the Federal Aviation Administration s (FAA) Federal Aviation Regulations (FARs). If MRM training is important to enhance aviation technicians working behavior, the rationale to not regulate it opens a window for study. This research aims to inductively investigate the FAA s regulatory rationale concerning MRM training based on direct inputs from the FAA s Aviation Rulemaking Advisory Committee (ARAC) members. Delphi methodology associated with purposive sampling technique was adopted. The result revealed that the FAA cannot regulate MRM because the aviation industry is strongly opposed to it due to the lack of training budgets, the need of a quantifiable cost-effect analysis, concern over the FAA s inspection workforce, an ongoing voluntary alternative called the Air Transportation Surveillance System (ATOS), the government s lower priority on maintenance after 9/11, and the airlines tight embracement of operational flexibility without regulation.

  6. 75 FR 12768 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... Hematology, Office of Blood Research and Review, CBER, FDA. FDA intends to make background material...

  7. 77 FR 29667 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-18

    ... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research,...

  8. 75 FR 72834 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... 14, 2010, in the morning, the committee will discuss the risk of dengue virus infection in...

  9. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice...

  10. 78 FR 38351 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of..., Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends...

  11. 78 FR 56899 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors. In the...

  12. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... announcing an amendment to the notice of meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register of September 20, 2010 (75 FR 57279). The amendment is being made... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Amendment of...

  13. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... meeting. Agenda: On July 22, 2013, the committee will discuss the Assessment of...

  14. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the...

  15. 75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... current research in a range of fields relevant to improving risk communication at FDA, and...

  16. 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.

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

    PubMed

    1997-02-01

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

  18. 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

    ... 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... Disease Patient Advocacy Day. This meeting is intended to enhance the awareness of the rare...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Division of Freedom of Information Public Reading Room...

  4. 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....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Division of Freedom of Information Public Reading Room...

  5. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room...

  6. 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....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Division of Freedom of Information Public Reading Room...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room...

  8. 78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

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

  9. Adverse Drug Events caused by Serious Medication Administration Errors

    PubMed Central

    Sawarkar, Abhivyakti; Keohane, Carol A.; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

    2013-01-01

    OBJECTIVE To determine how often serious or life-threatening medication administration errors with the potential to cause patient harm (or potential adverse drug events) result in actual patient harm (or adverse drug events (ADEs)) in the hospital setting. DESIGN Retrospective chart review of clinical events that transpired following observed medication administration errors. BACKGROUND Medication errors are common at the medication administration stage for hospitalized patients. While many of these errors are considered capable of causing patient harm, it is not clear how often patients are actually harmed by these errors. METHODS In a previous study where 14,041 medication administrations in an acute-care hospital were directly observed, investigators discovered 1271 medication administration errors, of which 133 had the potential to cause serious or life-threatening harm to patients and were considered serious or life-threatening potential ADEs. In the current study, clinical reviewers conducted detailed chart reviews of cases where a serious or life-threatening potential ADE occurred to determine if an actual ADE developed following the potential ADE. Reviewers further assessed the severity of the ADE and attribution to the administration error. RESULTS Ten (7.5% [95% C.I. 6.98, 8.01]) actual adverse drug events or ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% [95% C.I. 2.12, 3.6]) serious and life threatening potential ADEs led to serious or life threatening ADEs. Half of the ten actual ADEs were caused by dosage or monitoring errors for anti-hypertensives. The life threatening ADE was caused by an error that was both a transcription and a timing error. CONCLUSION Potential ADEs at the medication administration stage can cause serious patient harm. Given previous estimates of serious or life-threatening potential ADE of 1.33 per 100

  10. 75 FR 66773 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-29

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... were either recently approved by FDA or, are in late stage development for an adult oncology...

  11. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee...

  12. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... ] (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... relevance and potential use of such measures in the pediatric development plans of oncology products....

  13. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... plans for four products that are in development for an adult oncology indication. The subcommittee...

  14. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of..., are in late stage development for an adult oncology indication, or in late stage development...

  15. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... late stage development for various adult oncology indications. The subcommittee will consider...

  16. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other...

  17. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other...

  18. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other...

  19. 75 FR 9422 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of....) Contact Person: Cristi Stark, Office of Science, Center for Tobacco Products, Food and Drug...

  20. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of July 22, 2011 (76 FR... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory...

  1. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... preceded by oral communication or by a visit from an authorized representative of the local Food and Drug... 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...

  2. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... preceded by oral communication or by a visit from an authorized representative of the local Food and Drug... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  3. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... preceded by oral communication or by a visit from an authorized representative of the local Food and Drug... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  4. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... preceded by oral communication or by a visit from an authorized representative of the local Food and Drug... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  5. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... preceded by oral communication or by a visit from an authorized representative of the local Food and Drug... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  6. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... drawn to the order of the Food and Drug Administration, collectible at par in Washington, DC....

  7. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... drawn to the order of the Food and Drug Administration, collectible at par in Washington, DC....

  8. [Perinatal drug administration and risks of functional teratogenic defects].

    PubMed

    Benesová, O

    1994-01-31

    The success of perinatal medicine in saving the risk pregnancies and the lives of very immature and injured newborns is connected with a growing use of drugs which may disturb perinatal ontogenetic processes characterized by intensive histogenesis and cytodifferentiation of already formed organs, predominantly the brain. The administered drugs can change the program of the formation of neural nets, synapses, receptors and neurotransmitters and induce permanent deviations of brain cytoarchitectonics and neurobiochemical equipment. This pathology is not evident at birth, but forms the basis for functional defects of the brain which become apparent gradually during maturation or even in adulthood as neuro-psychological deviations e.g. minimal brain dysfunction or mental retardation in school children, sensori-motor deficits, epilepsy, psychic lability and maladjustment which may represent a predisposition to psychoses. Clinical recognition of this functional teratogenic action of the drug is hampered by the long time interval (upto decades) between the drug administration and its consequences what makes the identification of causal relations very difficult. Consequently, experimental research is necessary concerning functional teratogenicity of all drugs given in perinatal period, however under the precondition of adequate animal models with sufficient validity for the extrapolation on human level. The synopsis of current knowledge in this field reveals great numbers of urgent problems which are to be studied.

  9. Analysis of US Food and Drug Administration Warning Letters

    PubMed Central

    Salas, Maribel; Martin, Michelle; Pisu, Maria; McCall, Erin; Zuluaga, Alvaro; Glasser, Stephen P.

    2013-01-01

    Background Recent studies have suggested that there has been an increase in the number of ‘warning letters’ issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion. Methods All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached. Results Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims. Discussion There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines. Conclusion We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the

  10. Drug-resin drug interactions in patients with delayed gastric emptying: What is optimal time window for drug administration?

    PubMed

    Camilleri, M

    2016-08-01

    Most drug-drug interactions involve overlap or competition in drug metabolic pathways. However, there are medications, typically resins, whose function is to bind injurious substances such as bile acids or potassium within the digestive tract. The objective of this article is to review the functions of the stomach and the kinetics of emptying of different food forms or formulations to make recommendations on timing of medication administration in order to avoid intragastric drug interactions. Based on the profiles and kinetics of emptying of liquid nutrients and homogenized solids, a window of 3 h between administration of a resin drug and another 'target' medication would be expected to allow a median of 80% of medications with particle size <1 mm to empty from the stomach and, hence, avoid potential interaction such as binding of the 'target' medication within the stomach. PMID:26987693

  11. Police referral of drivers to the Maryland Motor Vehicle Administration's Medical Advisory Board.

    PubMed

    Soderstrom, Carl A; Scottino, Mary Anne; Joyce, John J; Burch, Cynthia; Ho, Shiu M; Kerns, Timothy J

    2009-10-01

    In the 50 United States and the District of Columbia law enforcement medical referrals are accepted by licensing agencies. This study assessed driving actions, medical concerns, and medical conditions in 486 police referrals to the Medical Advisory Board of the Maryland Motor Vehicle Administration during a 25-month period. Driving actions, medical concerns, and medical conditions were grouped into categories and entered into a database. These elements were analyzed relative to driver age and sex. In addition, the issuance of citations for driving violations was studied relative to age and sex. A greater percentage of drivers 60 years of age or greater (senior adults) were referred compared to the general population of licensed drivers that age, being 71.4% vs 20.6% (p <0.01). Crashing, the most common driving action, was not associated with age or sex. Among driving actions frequently mentioned relative to older drivers, only confusion of pedals was associated with senior adults drivers as compared to younger drivers (6.1% vs 0.1%, p <0.01). Of the most frequently mentioned medical concerns, confusion/disorientation was associated with being a senior adult (p <0.01), while loss of consciousness was associated with younger drivers (p <0.01). The most frequently mentioned medical conditions, diabetes and seizure, were associated with being under 60 years of age. All mentions of dementia were in senior adult drivers. Compared with younger drivers, drivers 60 years of age or older, were less often summoned for driving violations, being 33.0% vs 53.5% (p <0.01), respectively. The threshold for the issuance of fewer citations was lower for men (40 to 59 years of age) compared to women (60 years of age or greater). Studies are needed to correlate specific traffic violations and/or crashes to specific medical conditions.

  12. [Intravesical therapy with mitomycin through electromotive drug administration].

    PubMed

    Verri, Cristian; Liberati, Emanuele; Celestino, Francesco; De Carlo, Francesco; Torelli, Fiammetta; Di Stasi, Savino M

    2013-01-01

    In the management of non-muscle invasive bladder cancer (NMIBC), high-level evidence supports the widespread practice of intravesical therapy with mitomycin-C (MMC). Randomized trials showed a significant reduction in short-term recurrence compared with transurethral resection of bladder tumor (TURBT) alone, but little effect on long-term and no impact at all in preventing progression. Electromotive drug administration (EMDA®) offers a means of controlling and enhancing the tissue transport of certain drugs, in order to increase their efficacy. In both laboratory and clinical studies, intravesical electromotive drug administration (EMDA) increases MMC bladder uptake, resulting in an improved clinical efficacy in NMIBC without systemic side effects. New frameworks for treatment of NMIBC - e.g., sequential intravesical BCG and EMDA/MMC, as well as intravesical EMDA/MMC immediately before TURBT - have provided promising preliminary results with higher remission rates and longer remission times, and they are a priority to minimise the costs of disease management. These findings suggest EMDA-enhanced MMC efficacy against urothelial cancer could be a major therapeutic breakthrough in the treatment of NMIBC.

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

    PubMed

    Sunstein, C R

    1998-04-01

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

  14. 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

  15. 77 FR 55863 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... SPACE ADMINISTRATION NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Science Advisory Group....

  16. 75 FR 65497 - Science Board Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... HUMAN SERVICES Food and Drug Administration Science Board Advisory Committee; Notice of Meeting AGENCY... 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...

  17. 76 FR 25359 - Science Board Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration Science Board Advisory Committee; Notice of Meeting AGENCY... 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 Food...

  18. 76 FR 42714 - Science Board Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... HUMAN SERVICES Food and Drug Administration Science Board Advisory Committee; Notice of Meeting AGENCY... 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 Food...

  19. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this guidance with labeling recommendations because of concerns that both healthcare providers and patients...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of...

  1. 77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

    ... 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...

  2. 76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... 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...

  3. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration,...

  4. 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...

  5. 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... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS....

  6. 78 FR 42381 - Administrative Detention of Drugs Intended for Human or Animal Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... July 15, 2013 Part IV Department of Health and Human Services Food and Drug Administration 21 CFR Parts... / Proposed Rules#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 Administrative Detention of Drugs Intended for Human or Animal Use AGENCY: Food and...

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

    PubMed

    Baker, R

    1995-06-01

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

  8. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 drug... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration...

  9. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 drug... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration...

  10. 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...

  11. Bioequivalence of generic drugs: a simple explanation for a US Food and Drug Administration requirement.

    PubMed

    Andrade, Chittaranjan

    2015-06-01

    There is a widespread misconception that for a generic drug to be deemed bioequivalent to a branded drug, it must contain 80%-125% of the active ingredient that is present in the branded version. More correctly, bioequivalence is studied in randomized crossover trials that compare the generic drug with the reference agent, and the relevant outcome measures are pharmacokinetic (PK) parameters such as peak drug concentration and area under the curve, which describe the rate and extent of absorption of the drug. The ratio of each PK characteristic of the generic drug to the reference drug is computed; the ideal value of this ratio is 1:1, or just 1.00 (indicating a perfect match, or perfect bioequivalence). Because this ideal is probably unattainable, the US Food and Drug Administration requires that the 90% confidence interval of the PK ratio should lie between 0.80 and 1.25. For the entire 90% confidence interval to meet this requirement, the mean PK value of the generic product should actually lie quite close to that of the reference standard. Therefore, the variation between the generic and the reference is actually small. These concepts are explained in this article with the help of simple, easy-to-understand examples.

  12. 78 FR 9917 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-12

    ...) portfolio and project management; Senior Executive Service (SES) leadership development and SES performance... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established...

  13. 77 FR 12841 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... recommendations aimed at improving Information Technology (IT) portfolio and project management, IT vendor... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established...

  14. 76 FR 53901 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... improve government performance in the areas of IT portfolio and project management, IT vendor performance... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established...

  15. 77 FR 59399 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-27

    ... Information Technology (IT) portfolio and project management, IT vendor performance management, Senior... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board (PMAB), a Federal Advisory Committee established...

  16. 78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    .../AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call... Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital disorder caused by the absence.../default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure:...

  17. Modeling of Corneal and Retinal Pharmacokinetics after Periocular Drug Administration

    PubMed Central

    Amrite, Aniruddha C.; Edelhauser, Henry F.; Kompella, Uday B.

    2012-01-01

    .99) with the observed values in the SD rat corneas. Similar pharmacokinetics models explain drug delivery to the cornea in rat and rabbit animal models. Retinal pharmacokinetics after periocular drug administration can be explained with a four-compartment (periocular space, choroid-containing transfer compartment, retina, and distribution compartment) model with elimination from the periocular space, retina, and choroid compartment. Inclusion of a dissolution–release step before the drug is available for absorption or elimination better explains retinal tmax. Good fits were obtained in both the BN (r = 0.99) and SD (r = 0.99) rats for retinal celecoxib using the same model; however, the parameter estimates differed. Conclusions Corneal and retinal pharmacokinetics of small lipophilic molecules after periocular administration can be described by compartment models. The modeling analysis shows that (1) leak-back from the site of administration most likely contributes to the apparent lack of an increase phase in corneal concentrations; (2) elimination via the conjunctival or periocular blood and lymphatic systems contributes significantly to drug clearance after periocular injection; (3) corneal pharmacokinetics of small lipophilic molecules can be explained by using similar models in rats and rabbits; and (4) although there are differences in some retinal pharmacokinetics parameters between the pigmented and nonpigmented rats, the physiological basis of these differences has yet to be ascertained. PMID:18172109

  18. DEWORMING DELUSIONS? MASS DRUG ADMINISTRATION IN EAST AFRICAN SCHOOLS.

    PubMed

    Allen, Tim; Parker, Melissa

    2016-09-01

    Recent debates about deworming school-aged children in East Africa have been described as the 'Worm Wars'. The stakes are high. Deworming has become one of the top priorities in the fight against infectious diseases. Staff at the World Health Organization, the Gates Foundation and the World Bank (among other institutions) have endorsed the approach, and school-based treatments are a key component of large-scale mass drug administration programmes. Drawing on field research in Uganda and Tanzania, and engaging with both biological and social evidence, this article shows that assertions about the effects of school-based deworming are over-optimistic. The results of a much-cited study on deworming Kenyan school children, which has been used to promote the intervention, are flawed, and a systematic review of randomized controlled trials demonstrates that deworming is unlikely to improve overall public health. Also, confusions arise by applying the term deworming to a variety of very different helminth infections and to different treatment regimes, while local-level research in schools reveals that drug coverage usually falls below target levels. In most places where data exist, infection levels remain disappointingly high. Without indefinite free deworming, any declines in endemicity are likely to be reversed. Moreover, there are social problems arising from mass drug administration that have generally been ignored. Notably, there are serious ethical and practical issues arising from the widespread practice of giving tablets to children without actively consulting parents. There is no doubt that curative therapy for children infected with debilitating parasitic infections is appropriate, but overly positive evaluations of indiscriminate deworming are counter-productive. PMID:27428063

  19. Suspected drug eruption in seven dogs during administration of flucytosine.

    PubMed

    Malik, R; Medeiros, C; Wigney, D I; Love, D N

    1996-10-01

    7 of 8 dogs receiving combination drug therapy consisting of flucytosine together with amphotericin B and/or a triazole for cryptococcosis or aspergillosis developed cutaneous or mucocutaneous eruptions during the course of treatment. Lesions resolved in all cases following discontinuation of flucytosine despite continued administration of other antifungals, suggesting the eruption was referable primarily to the flucytosine component of therapy. Lesions developed 13 to 41 days (median 20 days) after commencing flucytosine (105 to 188 mg/kg/day divided and given every 8 h; median dose rate 150 mg/kg/day). The cumulative dose of flucytosine given prior to the first signs of the drug eruption ranged from 1.7 to 6.8 g/kg (median 2.3 g/kg). The eruptions consisted of depigmentation, followed by ulceration, exudation and crust formation. The scrotum was affected in all 4 male dogs, the nasal plane in 6 of 7 cases, while the lips, vulva, external ear canal and integument were involved in a smaller number of cases. There was considerable variation in the severity of lesions, with changes being most marked when flucytosine was continued for several days after lesions first appeared. Some dogs experienced malaise and inappetence in association with the suspected drug eruption. Healing took a variable period, typically in excess of 2 weeks after discontinuing flucytosine, with up to 2 months being required for total resolution of the lesions. All lesions resolved eventually without scarring or permanent loss of pigment. PMID:8937669

  20. 21 CFR 14.30 - Chairman of an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chairman of an advisory committee. 14.30 Section 14.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... a full-time employee of FDA, the executive secretary or other designated agency employee,...

  1. 21 CFR 14.95 - Compensation of advisory committee members.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL..., including the Commissioned Corps of the Public Health Service, provide service on Food and...

  2. 21 CFR 14.30 - Chairperson of an advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Chairperson of an advisory committee. 14.30 Section 14.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Chairperson is not a full-time employee of FDA, the Designated Federal Officer or other designated...

  3. 21 CFR 14.95 - Compensation of advisory committee members.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL..., including the Commissioned Corps of the Public Health Service, provide service on Food and...

  4. 77 FR 53920 - NASA Federal Advisory Committees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    ... SPACE ADMINISTRATION NASA Federal Advisory Committees AGENCY: National Aeronautics and Space... amended, the National Aeronautics and Space Administration, and in accordance with the Memorandum for the... NASA's Federal advisory committees. NASA's Federal advisory committees have member vacancies from...

  5. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

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

  6. 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

    ... Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-- Discontinuance... concern that, although the Orange Book lists all drug products with approved new drug applications (NDA) and abbreviated new drug applications (ANDA), it is not possible to determine whether the...

  7. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... chapter for OTC drugs. (2) A protocol for a test or study, unless it is shown to fall within the exemption... 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...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD...

  9. Tetanic fade following administration of nondepolarizing neuromuscular blocking drugs.

    PubMed

    Gibson, F M; Mirakhur, R K

    1989-06-01

    Fade in response to tetanic stimulation was studied following administration of atracurium 120 or 225 micrograms/kg, vecuronium 23 or 40 micrograms/kg, pancuronium 30 or 60 micrograms/kg, or d-tubocurarine 185 or 450 micrograms/kg. Ten patients received each dose and tetanic fade was measured at maximum block in the patients, who received the lower doses of the relaxants or at 10% recovery in those who received the higher doses. Fade during tetanic stimulation was generally similar in all the groups with the exception of the higher dose of pancuronium which showed a significantly greater fade in comparison with the higher doses of atracurium and d-tubocurarine. If fade in response to tetanic stimulation represents a prejunctional effect, the results from the present study suggest that neuromuscular blocking drugs cannot be differentiated with respect to their relative prejunctional effects by measurement of tetanic fade during established block after administration of clinically useful doses as used in the present study.

  10. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory... should have normal gonioscopic anatomy and a visually significant cataract eligible...

  11. 76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... Science and Clinical Pharmacology. General Function of the Committee: To provide advice and... April 13, 2010, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology...

  12. 78 FR 11207 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory Committee... be open to the public. Name of Committee: Transmissible Spongiform Encephalopathies...

  13. 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

    ... Health AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and...

  14. 21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

    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 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...

  15. 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...

  16. 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...

  17. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Single-Ingredient, Immediate-Release Drug Products... AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and...

  20. 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

    ... importers currently rely to help manage the safety of their global food supply chains. The purpose of these... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 Food and Drug Administration Food... of Third-Party Auditors/Certification Bodies; Public Meetings AGENCY: Food and Drug...

  1. 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

    ... importers currently rely to help manage the safety of their global food supply chains. The purpose of the... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 Food and Drug Administration Food... of Third-Party Auditors/Certification Bodies; Public Meeting AGENCY: Food and Drug...

  2. 77 FR 55845 - Science Board to the Food and Drug Administration: Request for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

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

  3. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

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

  4. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  5. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  6. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  7. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  8. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  9. 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

    ... 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 plan... require the formation of a task force to develop and implement a strategic plan for enhancing the...

  10. 77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function... multilumen device with two balloons mounted near the distal tip. The proximal end has a multiport...

  11. 76 FR 81513 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee..., Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and... Gene Therapies, Center for Biologics Evaluation and Research, FDA. FDA intends to make...

  12. 76 FR 49774 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory...

  13. 76 FR 22405 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... gene therapy products for the treatment of retinal disorders. Topics to be considered include...

  14. 75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... Lentiviral Vector Based Gene Therapy Products. FDA intends to make background material available to...

  15. 76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory...

  16. 78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center...

  17. 76 FR 18768 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  18. 78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  19. 77 FR 63840 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee..., Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and..., Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and...

  20. 77 FR 65693 - Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... Therapies Advisory Committee. This meeting was announced in the Federal Register of October 17, 2012 (77 FR... Register of October 17, 2012, FDA announced that a meeting of the Cellular, Tissue and Gene...

  1. 78 FR 79699 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-31

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee..., Tissue, and Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA. On February...

  2. 75 FR 72832 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  3. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  4. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  5. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  6. 75 FR 65641 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... Meetings.'' Contact Person: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and...

  7. 76 FR 58019 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... p.m., and on November 3, 2011, from 8 a.m. to 5 p.m. Location: Center for Tobacco Products, Food...

  8. 76 FR 2398 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory.... Location: Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD 20850. The phone number is...

  9. 76 FR 32219 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... July 22, 2011, from 8 a.m. to 5 p.m. Location: Center for Tobacco Products, Food and...

  10. 76 FR 4705 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-26

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory.... Location: Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD, 20850. The telephone number...

  11. 75 FR 47308 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee General Function of... number is 301-590-0044. Contact Person: Cristi Stark, Center for Tobacco Products, Food and...

  12. 77 FR 7589 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory.... to 5 p.m., and on March 2, 2012, from 8 a.m. to 1 p.m. Location: Center for Tobacco Products,...

  13. 76 FR 10609 - Tobacco Products Scientific Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ...) is announcing an amendment to the notice of a meeting of the Tobacco Products Scientific Advisory Committee. This meeting was announced in the Federal Register of January 26, 2011 (76 FR 4705). The... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Amendment...

  14. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-08

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and...

  15. 77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-18

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... lines derived from human tumors for vaccine manufacture. FDA intends to make background...

  16. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season....

  17. 77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November...

  18. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends...

  19. 78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS- d). The.../Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link....

  20. 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...

  1. Caregivers' perception of drug administration safety for pediatric oncology patients.

    PubMed

    Harris, Nariman; Badr, Lina Kurdahi; Saab, Raya; Khalidi, Aziza

    2014-01-01

    Medication errors (MEs) are reported to be between 1.5% and 90% depending on many factors, such as type of the institution where data were collected and the method to identify the errors. More significantly, the risk for errors with potential for harm is 3 times higher for children, especially those receiving chemotherapy. Few studies have been published on averting such errors with children and none on how caregivers perceive their role in preventing such errors. The purpose of this study was to evaluate pediatric oncology patient's caregivers' perception of drug administration safety and their willingness to be involved in averting such errors. A cross-sectional design was used to study a nonrandomized sample of 100 caregivers of pediatric oncology patients. Ninety-six of the caregivers surveyed were well informed about the medications their children receive and were ready to participate in error prevention strategies. However, an underestimation of potential errors uncovered a high level of "trust" for the staff. Caregivers echoed their apprehension for being responsible for potential errors. Caregivers are a valuable resource to intercept medication errors. However, caregivers may be hesitant to actively communicate their fears with health professionals. Interventions that aim at encouraging caregivers to engage in the safety of their children are recommended.

  2. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

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

  3. 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...

  4. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

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

  5. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

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

  6. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

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

  7. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

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

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a...

  9. 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...

  10. 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... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  11. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  12. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  13. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  14. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  15. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1)...

  16. 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

  17. 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.

  18. 21 CFR 14.55 - Termination of advisory committees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 14.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) of the Public Health Service Act, as added by the Radiation Control for Health and Safety Act of 1968... advisory committee established by section 917 of the Family Smoking Prevention and Tobacco Control Act...

  19. 21 CFR 14.55 - Termination of advisory committees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 14.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) of the Public Health Service Act, as added by the Radiation Control for Health and Safety Act of 1968... advisory committee established by section 917 of the Family Smoking Prevention and Tobacco Control Act...

  20. 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 HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and Human Services and the Association of Minority...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

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

  4. 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,...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

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

  6. 77 FR 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...

  7. 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...

  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 50589 - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... significantly from one another, we decided against publishing their full texts in the Federal Register (51 FR... HUMAN SERVICES Food and Drug Administration 21 CFR Part 20 Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations AGENCY:...

  10. 28 CFR 16.98 - Exemption of the Drug Enforcement Administration (DEA) Systems-limited access.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Exemption of the Drug Enforcement... PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION Exemption of Records Systems Under the Privacy Act § 16.98 Exemption of the Drug Enforcement Administration (DEA) Systems—limited access. (a) The...

  11. 28 CFR 16.98 - Exemption of the Drug Enforcement Administration (DEA) Systems-limited access.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Exemption of the Drug Enforcement... PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION Exemption of Records Systems Under the Privacy Act § 16.98 Exemption of the Drug Enforcement Administration (DEA) Systems—limited access. (a) The...

  12. 77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative... and Human Services responding to a January 18, 2011, Presidential Memorandum on Regulatory Compliance, (76 FR 3825, January 21, 2011), FDA recounted the actions it had already implemented, as well as...

  13. 76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... the Agency's Web site and call the appropriate advisory committee hot line/phone line to learn about..., manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients...

  14. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... Marriott Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd... attendance of the public at its advisory committee meetings and will make every effort to accommodate...

  15. 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.

  16. 77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  17. 77 FR 71195 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  18. 78 FR 77687 - Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ..., the SAB will hear an update from each of NCTR's research Division's the Office of ] Science... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This...

  19. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can... HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices...

  20. New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.

    PubMed

    Huang, Shiew-Mei; Strong, John M; Zhang, Lei; Reynolds, Kellie S; Nallani, Srikanth; Temple, Robert; Abraham, Sophia; Habet, Sayed Al; Baweja, Raman K; Burckart, Gilbert J; Chung, Sang; Colangelo, Philip; Frucht, David; Green, Martin D; Hepp, Paul; Karnaukhova, Elena; Ko, Hon-Sum; Lee, Jang-Ik; Marroum, Patrick J; Norden, Janet M; Qiu, Wei; Rahman, Atiqur; Sobel, Solomon; Stifano, Toni; Thummel, Kenneth; Wei, Xiao-Xiong; Yasuda, Sally; Zheng, Jenny H; Zhao, Hong; Lesko, Lawrence J

    2008-06-01

    Predicting clinically significant drug interactions during drug development is a challenge for the pharmaceutical industry and regulatory agencies. Since the publication of the US Food and Drug Administration's (FDA's) first in vitro and in vivo drug interaction guidance documents in 1997 and 1999, researchers and clinicians have gained a better understanding of drug interactions. This knowledge has enabled the FDA and the industry to progress and begin to overcome these challenges. The FDA has continued its efforts to evaluate methodologies to study drug interactions and communicate recommendations regarding the conduct of drug interaction studies, particularly for CYP-based and transporter-based drug interactions, to the pharmaceutical industry. A drug interaction Web site was established to document the FDA's current understanding of drug interactions (http://www.fda.gov/cder/drug/drugInteractions/default.htm). This report provides an overview of the evolution of the drug interaction guidances, includes a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document, Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling.

  1. 75 FR 31760 - Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... Grain Inspection, Packers and Stockyards Administration Advisory Committee Meeting AGENCY: Grain... of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory... Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards...

  2. 75 FR 67682 - Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-03

    ... Grain Inspection, Packers and Stockyards Administration Advisory Committee Meeting AGENCY: Grain... of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory... Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards...

  3. 76 FR 30305 - Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... Grain Inspection, Packers and Stockyards Administration Advisory Committee Meeting AGENCY: Grain... of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory... Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards...

  4. 77 FR 67029 - NASA Advisory Council Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... SPACE ADMINISTRATION NASA Advisory Council Meeting AGENCY: National Aeronautics and Space Administration... amended, the National Aeronautics and Space Administration announces a meeting of the NASA Advisory... are local time. ADDRESSES: NASA Marshall Space Flight Center, Building 4200, Room P- 110,...

  5. Update on administration of anesthetics and psychoactive drugs for pain management in China.

    PubMed

    Gu, Weiping

    2015-06-01

    Anesthetics and psychoactive drugs could relieve diseases, if used properly. However, they can cause dependency, and their misuse or abuse could adversely affect people's health and social stability. For a long time, the Chinese government has been reinforcing the regulation on anesthetics and psychoactive drugs to ensure their legal and proper usage, and to prevent abuse. The state council issued 'the regulations on the administration of anesthetic drugs and psychotropic drugs' in 2005, based on which a legal system was established for administration of anesthetics and psychoactive drugs with the objectives of ensuring their legitimate medical utilization, and preventing illegal abuse.

  6. 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... AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.110 Data and information about Food and Drug Administration employees. (a) The name, title, grade,...

  7. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and...

  8. 75 FR 4982 - Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ...Under delegated authority, the Administrator of the Drug Enforcement Administration (DEA), Department of Justice, is amending the appendix to the Justice Department regulations to redelegate certain functions and authority which were vested in the Attorney General by the Controlled Substances Act and subsequently delegated to the Administrator of...

  9. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... lawful activities of DEA personnel in an amount not to exceed $50,000.00 in any one case. (b) Notwithstanding the provisions of 28 CFR 0.104, the Administrator of DEA is authorized to redelegate the power and... claims against the Drug Enforcement Administration. (a) The Administrator of DEA is authorized...

  10. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... lawful activities of DEA personnel in an amount not to exceed $50,000.00 in any one case. (b) Notwithstanding the provisions of 28 CFR 0.104, the Administrator of DEA is authorized to redelegate the power and... claims against the Drug Enforcement Administration. (a) The Administrator of DEA is authorized...

  11. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... lawful activities of DEA personnel in an amount not to exceed $50,000.00 in any one case. (b) Notwithstanding the provisions of 28 CFR 0.104, the Administrator of DEA is authorized to redelegate the power and... claims against the Drug Enforcement Administration. (a) The Administrator of DEA is authorized...

  12. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... lawful activities of DEA personnel in an amount not to exceed $50,000.00 in any one case. (b) Notwithstanding the provisions of 28 CFR 0.104, the Administrator of DEA is authorized to redelegate the power and... claims against the Drug Enforcement Administration. (a) The Administrator of DEA is authorized...

  13. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... lawful activities of DEA personnel in an amount not to exceed $50,000.00 in any one case. (b) Notwithstanding the provisions of 28 CFR 0.104, the Administrator of DEA is authorized to redelegate the power and... claims against the Drug Enforcement Administration. (a) The Administrator of DEA is authorized...

  14. Administrator's Handbook for Crime Prevention and Drug Education.

    ERIC Educational Resources Information Center

    Texas Education Agency, Austin. Div. of Crime Prevention and Drug Education.

    Acts of three Texas Legislatures have mandated that the schools of Texas provide a program for all public school students, grades K-12, in crime prevention and drug education. To assist schools in formulating a philosophy about and in developing appropriate programs and techniques for drug education and crime prevention programs, the Texas…

  15. Use of Cough and Cold Medications in Severe Bronchiolitis Before and After a Health Advisory Warning against Their Use

    PubMed Central

    O’Donnell, Katherine; Mansbach, Jonathan M.; LoVecchio, Frank; Cheng, John; Piedra, Pedro A.; Clark, Sunday; Sullivan, Ashley F.; Camargo, Carlos A.

    2015-01-01

    We compared the use of cough and cold medications in two multicenter studies of young children hospitalized with bronchiolitis before and after the 2008 Food and Drug Administration cough and cold medications advisory. Although cough and cold medications use decreased after the advisory, nearly 20% of children age 12–23.9 months with severe bronchiolitis received cough and cold medications. PMID:25888349

  16. Use of Cough and Cold Medications in Severe Bronchiolitis before and after a Health Advisory Warning against Their Use.

    PubMed

    O'Donnell, Katherine; Mansbach, Jonathan M; LoVecchio, Frank; Cheng, John; Piedra, Pedro A; Clark, Sunday; Sullivan, Ashley F; Camargo, Carlos A

    2015-07-01

    We compared the use of cough and cold medications in 2 multicenter studies of young children hospitalized with bronchiolitis before and after the 2008 Food and Drug Administration cough and cold medications advisory. Although cough and cold medication use decreased after the advisory, nearly 20% of children age 12-23.9 months with severe bronchiolitis received cough and cold medications.

  17. Annual report of the National Advisory Committee for Aeronautics (42nd). administrative report including Technical Report nos. 1254 to 1295

    NASA Technical Reports Server (NTRS)

    1957-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  18. Annual report of the National Advisory Committee for Aeronautics (35th). administrative report including Technical Report nos. 922 to 950

    NASA Technical Reports Server (NTRS)

    1951-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  19. Annual report of the National Advisory Committee for Aeronautics (29th) : administrative report including Technical Report nos. 752 to 773

    NASA Technical Reports Server (NTRS)

    1948-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  20. Annual report of the National Advisory Committee for Aeronautics (34th). administrative report including Technical Report nos. 892 to 921

    NASA Technical Reports Server (NTRS)

    1951-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  1. Annual report of the National Advisory Committee for Aeronautics (41st). administrative report including Technical Report nos. 1210 to 1253

    NASA Technical Reports Server (NTRS)

    1957-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  2. Annual report of the National Advisory Committee for Aeronautics (40th). administrative report including Technical Report nos. 1158-1209

    NASA Technical Reports Server (NTRS)

    1956-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  3. Annual report of the National Advisory Committee for Aeronautics (38th). administrative report including Technical Report nos. 1059 to 1110

    NASA Technical Reports Server (NTRS)

    1954-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  4. Annual report of the National Advisory Committee for Aeronautics (36th). administrative report including Technical Report nos. 951 to 1002

    NASA Technical Reports Server (NTRS)

    1951-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  5. Characteristics of small residential and commercial water systems that influence their likelihood of being on drinking water advisories in rural British Columbia, Canada: a cross-sectional study using administrative data.

    PubMed

    Edwards, Joanne E; Henderson, Sarah B; Struck, Sylvia; Kosatsky, Tom

    2012-12-01

    Health officials often lack information about characteristics that predict which water systems are most likely to be placed on and to persist on drinking water advisories (e.g. health warnings offering advice or information). This study uses data collected by the Interior Health Authority in British Columbia to characterize water systems on advisory for microbiological threats and to identify the variables associated with advisory status and length. By systematically extracting key characteristics, this study explores advisory status by examining associated variables: water systems size, administrative area, governance structure, water source, treatment level, and service type (e.g. residential or commercial systems). Results show residential and commercial water systems have different characteristics associated with advisory status and length. For residential systems, certain governance structures are more likely to be placed on and to stay on advisory, especially the cooperative governance structures not operated by local governments. For commercial systems, administrative area and system size were associated with advisory status, but not advisory length. The overall results highlight the influence of governance structure and support the need for targeted interventions to improve residential small water systems not operated by local governments or utilities. Lastly, these results show how health officials can use administrative data for program planning and evaluation. PMID:23165719

  6. 21 CFR 14.86 - Rights and responsibilities of nonvoting members of advisory committees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Rights and responsibilities of nonvoting members of advisory committees. 14.86 Section 14.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... nonvoting member shall exercise restraint in performing such functions and may not engage in...

  7. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., that requires the exercise of scientific judgment and a person who would be adversely affected by...

  8. 21 CFR 14.86 - Rights and responsibilities of nonvoting members of advisory committees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Rights and responsibilities of nonvoting members of advisory committees. 14.86 Section 14.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... nonvoting member shall exercise restraint in performing such functions and may not engage in...

  9. 21 CFR 14.86 - Rights and responsibilities of nonvoting members of advisory committees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Rights and responsibilities of nonvoting members of advisory committees. 14.86 Section 14.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... nonvoting member shall exercise restraint in performing such functions and may not engage in...

  10. 21 CFR 14.140 - Establishment of a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Establishment of a color additive advisory committee. 14.140 Section 14.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... carcinogenicity, that requires the exercise of scientific judgment and a person who would be adversely affected...

  11. 21 CFR 14.86 - Rights and responsibilities of nonvoting members of advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Rights and responsibilities of nonvoting members of advisory committees. 14.86 Section 14.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... nonvoting member shall exercise restraint in performing such functions and may not engage in...

  12. 21 CFR 14.31 - Consultation by an advisory committee with other persons.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Consultation by an advisory committee with other persons. 14.31 Section 14.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN.... Consultants may be either from outside the Government or from agencies other than the Food and...

  13. 21 CFR 14.31 - Consultation by an advisory committee with other persons.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Consultation by an advisory committee with other persons. 14.31 Section 14.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN.... Consultants may be either from outside the Government or from agencies other than the Food and...

  14. 21 CFR 14.31 - Consultation by an advisory committee with other persons.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Consultation by an advisory committee with other persons. 14.31 Section 14.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN.... Consultants may be either from outside the Government or from agencies other than the Food and...

  15. The administration of sulfonamide drugs to adult salmon

    USGS Publications Warehouse

    Amend, D.F.; Fryer, J.L.

    1968-01-01

    Mass treatment is the most convenient way to combat fish diseases. For example, drugs can be administered per os in diets, or chemicals can be added to the water. These methods are mostly ineffective in treating systemic infections of adult salmon because mature salmon do not feed, and many fish diseases cannot be controlled by chemical baths. Thus, effective treatment would require administering drugs to each individual.

  16. 75 FR 50797 - Motor Carrier Safety Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces that its Motor Carrier Safety Advisory Committee (MCSAC)...

  17. 75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces that the Agency's Motor Carrier Safety Advisory Committee...

  18. 77 FR 56909 - Aviation Rulemaking Advisory Committee (ARAC); Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... Federal Aviation Administration Aviation Rulemaking Advisory Committee (ARAC); Renewal AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Renewal. SUMMARY: The FAA announces the charter renewal of the Aviation Rulemaking Advisory Committee (ARAC), a Federal Advisory Committee that works...

  19. 78 FR 53497 - Commercial Space Transportation Advisory Committee; Closed Session

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... Federal Aviation Administration Commercial Space Transportation Advisory Committee; Closed Session AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory... closed session of the Commercial Space Transportation Advisory Committee (COMSTAC). The special...

  20. Administrative Destruction of Certain Drugs Refused Admission to the United States. Final rule.

    PubMed

    2015-09-15

    The Food and Drug Administration (FDA or Agency) is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by issuing a rule that provides to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to destruction. This regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Implementation of this authority will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain. PMID:26387150