Science.gov

Sample records for drug administration advisory

  1. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

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 HUMAN SERVICES Food and Drug Administration (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public...: Food and Drug Administration, HHS.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

  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

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

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 78 FR 37820 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... HUMAN SERVICES Food and Drug Administration Nonprescription 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...

  19. 76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting. AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of...

  5. 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...

  6. 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)...

  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... be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee... proposed indication for metreleptin is the treatment of metabolic disorders associated with...

  8. 75 FR 26264 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

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

  9. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by...

  10. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... 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 Function... primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... 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 Function... in patients with primary autonomic failure (Parkinson's Disease, Multiple System Atrophy, and...

  12. 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...

  13. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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 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...

  19. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy 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...

  20. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy 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...

  1. 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...

  2. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... 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 Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of...

  3. 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...

  4. 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...

  5. 78 FR 2677 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  6. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Joint Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  7. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  8. 75 FR 32189 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety...

    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 Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS....

  9. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  10. 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 Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS....

  11. 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 Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration,...

  12. 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....

  13. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... Advisory Committee. This meeting was announced in the Federal Register of February 2, 2010 (75 FR...

  14. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... 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 Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  15. 75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

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

  16. 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 Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  17. 77 FR 16038 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... 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; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee...

  18. 77 FR 6804 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

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

  19. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... 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 Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the...

  20. 78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

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

  1. 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 of a public advisory committee of the Food...

  2. 76 FR 80948 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... 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; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee...

  3. 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 Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  4. 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...

  5. 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...

  6. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee....

  7. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

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

  8. 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...

  9. 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...

  10. 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...

  11. 75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... 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 Function... failure. FDA intends to make background material available to the public no later than 2 business...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... 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 Function... Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of...

  18. 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

    ...The Food and Drug Administration (FDA) is requesting nominations for 12 members to serve on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research. FDA has a special interest in ensuring that women, minority groups, and individuals with physical disabilities are adequately represented on advisory committees and, therefore, extends particular encouragement......

  19. 75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

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

  20. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  1. 77 FR 48992 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... proposed indication (use) is as an adjunct to a low-fat diet and other lipid-lowering drugs with or without... 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...

  2. 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

    ... 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 Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  3. 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...

  4. 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; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...

  5. 76 FR 78283 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... 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; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...

  6. 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 Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  7. The Indonesian Drug Advisory Committee and the drug approval process.

    PubMed

    Darmansjah, I; Wardhini, S

    1991-01-01

    The Indonesian Food and Drug Agency began to evaluate drug applications in the early 1970s through an Advisory Committee. This was in response to the perestroika-like policy applied to our drug industry; nowadays there are more than 300 drug companies formulating some 13,5600 drug products. During 1977-1988, 603 drugs were evaluated by the Advisory Committee; 66% were single drugs and 34% were fixed dose combinations. Nine-hundred and twenty-five sessions were needed to arrive at decisions. Most of the applications (88.5%) were reviewed in one or two sessions but 8 drugs took 6-12 sessions. The time needed for assessment may vary from 1 to 3 months (61%), but some have needed almost a year and a half. There were 60% acceptances for single drugs and 35% for fixed combinations. PMID:2045840

  8. 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...

  9. 75 FR 75681 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... 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 Drugs... and circulation) of the central nervous system. The BBB is an area consisting of specialized...

  10. 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…

  11. 77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

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

  12. 76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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... resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood...

  2. DRUG ENFORCEMENT ADMINISTRATION REGISTRATION DATABASE

    EPA Science Inventory

    The Drug Enforcement Administration (DEA), as part of its efforts to control the abuse and misuse of controlled substances and chemicals used in producing some over-the-counter drugs, maintains databases of individuals registered to handle these substances. These databases are av...

  3. 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...

  4. 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...

  5. 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...

  6. 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

    ... Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Cancellation AGENCY: Food... Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee scheduled for... FR 67093). This meeting has been cancelled because the Agency believes the information received...

  7. 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...

  8. 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...

  9. 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,...

  10. 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

    ... Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY... Risk Management Advisory Committee. General Function of the Committees: To provide advice and... Pharmaceuticals, LLC and King Pharmaceuticals Research & Development, Inc., approved for the management...

  11. 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 and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant to section 10(d) of the... the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug...

  12. 77 FR 61004 - Request for Nominations for Voting Members on Public Advisory Committees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-05

    ... Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, and... for Biologics Evaluation Blood Products Advisory and Research, Food and Drug Administration, Committee... Advisory 3 September 1, 2013. Committee--individuals knowledgeable in clinical immunology/allergy....

  13. 29 CFR 775.1 - Advisory interpretations announced by the Administrator.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. Mass drug administration for malaria

    PubMed Central

    Poirot, Eugenie; Skarbinski, Jacek; Sinclair, David; Kachur, S Patrick; Slutsker, Laurence; Hwang, Jimee

    2013-01-01

    Background Mass drug administration (MDA), defined as the empiric administration of a therapeutic antimalarial regimen to an entire population at the same time, has been a historic component of many malaria control and elimination programmes, but is not currently recommended. With renewed interest in MDA and its role in malaria elimination, this review aims to summarize the findings from existing research studies and program experiences of MDA strategies for reducing malaria burden and transmission. Objectives To assess the impact of antimalarial MDA on population asexual parasitaemia prevalence, parasitaemia incidence, gametocytaemia prevalence, anaemia prevalence, mortality and MDA-associated adverse events. Search methods We searched the Cochrane Infectious Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE+, EMBASE, to February 2013. We also searched CABS Abstracts, LILACS, reference lists, and recent conference proceedings. Selection criteria Cluster-randomized trials and non-randomized controlled studies comparing therapeutic MDA versus placebo or no MDA, and uncontrolled before-and-after studies comparing post-MDA to baseline data were selected. Studies administering intermittent preventive treatment (IPT) to sub-populations (for example, pregnant women, children or infants) were excluded. Data collection and analysis Two authors independently reviewed studies for inclusion, extracted data and assessed risk of bias. Studies were stratified by study design and then subgrouped by endemicity, by co-administration of 8-aminoquinoline plus schizonticide drugs and by plasmodium species. The quality of evidence was assessed using the GRADE approach. Main results Two cluster-randomized trials, eight non-randomized controlled studies and 22 uncontrolled before-and-after studies are included in this review. Twenty-two studies (29 comparisons) compared MDA to placebo or no intervention of which two comparisons were

  19. 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...

  20. 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:...

  1. 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:...

  2. Drug Abuse Control--Administrative Guidelines.

    ERIC Educational Resources Information Center

    Los Angeles City Schools, CA.

    These guidelines were developed to assist administrators, teachers, and other staff members of the Los Angeles Public Schools in the formulation of an effective program designed to alleviate drug abuse. Staff responsibilities are spelled out. Specific attention is directed to the problems of drug abuse, drug possession and drug selling. The…

  3. 77 FR 64346 - Nonprescription Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... other changes. FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation and Research, Food.... This meeting was announced in the Federal Register of August 30, 2012 (77 FR 52743). The amendment is..., 301-796-9001, ] FAX: 301-847-8533, email: NDAC@fda.hhs.gov , or FDA Advisory Committee...

  4. 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...

  5. 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...

  6. 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...

  7. Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

    PubMed Central

    Kiet, Tuyen K.; Monk, Bradley J.; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S.; Amanam, Idoroenyi

    2014-01-01

    Background Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. Methods All applications referred to the ODAC from 2001 to 2012 were reviewed. Results Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001–2004, 2005–2008, 2009–2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Conclusion. Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs. PMID:24599479

  8. [Drug administration through enteral feeding catheters].

    PubMed

    Goñi Viguria, R; Sánchez Sanz, L; Asiain Erro, M; Baztán Indave, A

    2001-01-01

    Because of easiness and accessibility, the oral route of administration is usually the route of choice for medication delivery, as long as the oral drug form is available and the patients' circumstances allow it.In patients admitted to the intensive care unit this route is frequently altered. This provokes difficulties in swallowing and consequently an enteral feeding catheter must be inserted to supply the patient's nutritional requirements. This catheter is also used for the drug administration, which necessitates opening capsules or crushing pills before dilution. When added to drug-nutrient interactions, this process alters the drug's properties and modifies its pharmacokinetic profile, its pharmacological effect and the intensity of side effects. It can also provoke catheter obstruction. The aim of this study was to establish guidelines for drug administration through enteral feeding catheters. We provide a thorough review of the literature, describe oral drug forms, present a protocol for correct drug administration and provide a guide to the most commonly used drugs in our unit. For each of these drugs we include recommendations on administration and possible alternatives. PMID:11459545

  9. 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

    ... Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY... Risk Management Advisory Committee. General Function of the Committees: To provide advice and... moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic...

  10. 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,...

  11. 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,...

  12. 78 FR 69133 - Drug Enforcement Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... International, Inc. By Notice dated May 14, 2013, and published in the Federal Register on May 22, 2013, 78 FR... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug... renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of...

  13. 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... Tobacco Products Scientific Advisory Committee's required report to the Secretary of Health and...

  14. 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

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Risk Communication Advisory Committee...: Risk Communication Advisory Committee and Tobacco Products Scientific Advisory Committee....

  15. 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:...

  16. 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...

  17. 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...

  18. Blasé about drug administration.

    PubMed

    Castledine, Sir George

    The trouble with some tasks and procedures in nursing is that you get too used to them, and errors inevitably set in. No other area is as vulnerable to this as drug administration. A recent report from the National Patient Safety Agency highlighted that dozens of patients are killed every year by drug errors. In 2007, the watchdog received reports from NHS staff of 86 000 mistakes in prescribing or administering medicines, compared with 36 335 errors in 2005. In England and Wales, in 96% of cases the incidents caused low or no harm, but 37 patients died during 2007, and another 63 suffered severe harm. PMID:19966750

  19. 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...

  20. 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...

  1. Bioadhesion: new possibilities for drug administration?

    PubMed

    Woodley, J

    2001-01-01

    Bioadhesion (and mucoadhesion) is the process whereby synthetic and natural macromolecules adhere to mucosal surfaces in the body. If these materials are then incorporated into pharmaceutical formulations, drug absorption by mucosal cells may be enhanced or the drug released at the site for an extended period of time. For synthetic polymers, such as the chitosans, carbopols and carbomers, the mechanism of bio/mucoadhesion is the result of a number of different physicochemical interactions. Biological bio/mucoadhesives, such as plant lectins, show specific interactions with cell surfaces and mucin and are seen as the 'second generation' bioadhesives. Bioadhesive systems for drug administration via the buccal and nasal cavities are nearing the market; in the case of nasal bioadhesion, bioadhesive microparticles are used. A bioadhesive formulation for drug administration to the vagina is in use. The gastrointestinal tract is proving a more difficult site because of the rapid turnover of mucus, and relatively constant transit time, but intensive research is in progress. Micro- and nano-particles, coated with either bio/mucoadhesive polymers or specific biological bioadhesives, are showing some promise, but will require considerable research and development before reaching the market. PMID:11286325

  2. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate... material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll down to...

  3. 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 free Webcast. Visit the Risk Communication Advisory Committee Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/default.htm . The...

  4. 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...

  5. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 and compensation pertaining to a color additive advisory committee....

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 and compensation pertaining to a color additive advisory committee....

  7. 77 FR 62242 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ... 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... 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... and lessons from a selection of the FDA's previously issued communications, emphasizing...

  13. 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,...

  14. 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...

  15. 75 FR 67378 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-02

    ... 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.... Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, Office of Special Medical...

  16. 75 FR 7281 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ... 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... learn about possible modifications before coming to the meeting. Agenda: The Pediatric...

  17. Intrathecal drug administration in chronic pain syndromes.

    PubMed

    Ver Donck, Ann; Vranken, Jan H; Puylaert, Martine; Hayek, Salim; Mekhail, Nagy; Van Zundert, Jan

    2014-06-01

    Chronic pain may recur after initial response to strong opioids in both patients with cancer and patients without cancer or therapy may be complicated by intolerable side effects. When minimally invasive interventional pain management techniques also fail to provide satisfactory pain relief, continuous intrathecal analgesic administration may be considered. Only 3 products have been officially approved for long-term intrathecal administration: morphine, baclofen, and ziconotide. The efficacy of intrathecal ziconotide for the management of patients with severe chronic refractory noncancer pain was illustrated in 3 placebo-controlled trials. A randomized study showed this treatment option to be effective over a short follow-up period for patients with pain due to cancer or AIDS. The efficacy of intrathecal opioid administration for the management of chronic noncancer pain is mainly derived from prospective and retrospective noncontrolled trials. The effect of intrathecal morphine administration in patients with pain due to cancer was compared with oral or transdermal treatment in a randomized controlled trial, which found better pain control and fewer side effects with intrathecal opioids. Other evidence is derived from cohort studies. Side effects of chronic intrathecal therapy may either be technical (catheter or pump malfunction) or biological (infection). The most troublesome complication is, however, the possibility of granuloma formation at the catheter tip that may induce neurological damage. Given limited studies, the evidence for intrathecal drug administration in patients suffering from cancer-related pain is more compelling than that of chronic noncancer pain. PMID:24118774

  18. 77 FR 64346 - Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... Drugs Advisory Committee. This meeting was announced in the Federal Register of October 10, 2012 (77 FR... document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Paul Tran, Center for...

  19. 21 CFR 10.85 - Advisory opinions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Advisory opinions. 10.85 Section 10.85 Food and... PRACTICES AND PROCEDURES General Administrative Procedures § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability....

  20. 21 CFR 10.85 - Advisory opinions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Advisory opinions. 10.85 Section 10.85 Food and... PRACTICES AND PROCEDURES General Administrative Procedures § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability....

  1. 21 CFR 10.85 - Advisory opinions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Advisory opinions. 10.85 Section 10.85 Food and... PRACTICES AND PROCEDURES General Administrative Procedures § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability....

  2. 21 CFR 10.85 - Advisory opinions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Advisory opinions. 10.85 Section 10.85 Food and... PRACTICES AND PROCEDURES General Administrative Procedures § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability....

  3. 21 CFR 10.85 - Advisory opinions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Advisory opinions. 10.85 Section 10.85 Food and... PRACTICES AND PROCEDURES General Administrative Procedures § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability....

  4. 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...

  5. 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...

  6. 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...

  7. Aerospace Safety Advisory Panel report to the NASA acting administrator

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The level of activity of the Aerospace Safety Advisory Panel was increased smewhat during 1985 in concert with the increased mission rate of the National Space Transportation System, the evolutionary changes in management and operation of that program, and the preparation of the Vandenberg Launch Site; the implementation of the Program Definition Phase of the Space Station Program; and the actual flight testing of the X-29 research aircraft. Impending payload STS missions and NASA's overall aircraft operations are reviewed. The safety aspects of the LEASAT salvage mission were assessed. The findings and recommendation of the committee are summerized.

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

    PubMed

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

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

  9. 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...

  10. 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... Administrator of the FHWA, on infrastructure issues of concern to motorcyclists, including: (1) Barrier...

  11. 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...

  12. 77 FR 49446 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ...., Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor... , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. A notice in the...

  13. Antimalarial mass drug administration: ethical considerations.

    PubMed

    Cheah, Phaik Yeong; White, Nicholas J

    2016-07-01

    Falciparum malaria is a major cause of death and illness in tropical countries, particularly in childhood. In endemic countries, a significant proportion of the community is infected with malaria asymptomatically. One promising way to eliminate malaria is to give the entire population malaria treatment. This is called mass drug administration (MDA) and it raises a number of ethical issues, as possible long-term benefits are uncertain. The effectiveness of MDA is critically dependent on level of participation, so the promised benefits to the community can be annulled by non-participation of a small number of individuals. These potential benefits range a wide spectrum, from the permanent elimination of malaria (success) to a transient reduction in the prevalence of infection and the incidence of illness (failure). The drawbacks of MDA are: inconvenience, potential toxicity, loss of confidence in the elimination campaign, possible drug resistance (though highly unlikely), and the potential for a rebound of malaria illness (if immunity is lost and malaria is reintroduced later). Other ethical issues are related to balancing individual and public health interests, and potentially limiting individual autonomy by making MDA compulsory. PMID:27481834

  14. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

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

  15. 21 CFR 14.147 - Membership 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 Membership of a color additive advisory committee. 14.147 Section 14.147 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 §...

  16. 21 CFR 14.147 - Membership 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 Membership of a color additive advisory committee. 14.147 Section 14.147 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 §...

  17. 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

  18. 78 FR 58314 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... 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...

  19. 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...

  20. Advisory committee; Pediatric Advisory Committee; establishment. Final Rule.

    PubMed

    2004-08-01

    The Food and Drug Administration (FDA) is announcing the establishment of a Pediatric Advisory Committee in the Office of the Commissioner. Elsewhere in this issue of the Federal Register, FDA is publishing a document requesting nominations for the membership on this committee. This document adds the Pediatric Advisory Committee to the agency's list of standing advisory committees in 21 CFR 14.100. PMID:15287133

  1. 78 FR 44574 - Third Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

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

  2. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  3. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

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

  4. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

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

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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

  10. 78 FR 78368 - Allergenic Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

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

  11. 78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ... 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...

  12. 77 FR 20643 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

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

  13. 77 FR 45638 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

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

  14. 77 FR 4567 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

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

  15. 75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... 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...

  16. 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,...

  17. 76 FR 14414 - Allergenic Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

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

  18. 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...

  19. 78 FR 56900 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ...: AVAC@fda.hhs.gov , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the... committee information line to learn about possible modifications before coming to the meeting. Agenda: The... data, information, or views, orally or in writing, on issues pending before the committee....

  20. 77 FR 15110 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-14

    ... sexually acquired HIV-1 infection. FDA intends to make background materials available to the public no....'' Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Yvette....gov , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington,...

  1. 77 FR 17487 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... the treatment of HIV-1 infection in adults who are antiretroviral na ve or have no known substitutions...: 301-847- 8533, email: AVAC@fda.hhs.gov , or FDA Advisory Committee Information Line, 1-800-741-8138... presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those...

  2. United States Food and Drug Administration Product Label Changes

    PubMed Central

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

    2016-01-01

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

  3. 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. 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…

  5. 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...

  6. 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...

  7. 76 FR 46304 - Pediatric Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... 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..., September 22, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety...

  8. 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...

  9. 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...

  10. 21 CFR 14.22 - Meetings 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 Meetings of an advisory committee. 14.22 Section 14.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Meeting Procedures § 14.22 Meetings of an...

  11. 77 FR 55845 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the..., raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by... the contact person and submit a brief statement of the general nature of the evidence or...

  12. 77 FR 58400 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time...'s phone number is 301-589-5200. Contact Person: Diane Goyette, Center for Drug Evaluation and... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the...

  13. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ... meeting announced in the Federal ] Register of December 14, 2012 (77 FR 74486), originally scheduled for..., Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of... and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by...

  14. 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.''...

  15. Disinfection practices in intravenous drug administration.

    PubMed

    Helder, Onno K; Kornelisse, René F; Reiss, Irwin K M; Ista, Erwin

    2016-06-01

    The aim of the study was to determine the effectiveness of a feedback intervention on adherence to disinfection procedures during intravenous medication preparation and administration. We found that full adherence to the protocols significantly improved from 7.3% to 21.5% (P < .001) regarding medication preparation and from 7.9% to 15.5% (P = .012) regarding medication administration. However, disinfection practices still need improvement. PMID:26899528

  16. 78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-12

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

  17. 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...

  18. 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...

  19. Advisory Committee Report on Drug Abuse: Summations and Recommendations.

    ERIC Educational Resources Information Center

    Governor's Citizen Advisory Committee on Drugs, Salt Lake City, UT.

    A citizen's Drug Abuse Evaluation Committee was formed in Utah to evaluate past research and gather new data on basic questions concerning the drug problem. This booklet provides information based on the Committee's research, hearings, and an investigation of the current drug abuse problem in Utah. Data was also obtained from recorded testimony of…

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

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

    PubMed

    Baker, R

    1995-09-01

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

  7. 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...

  8. 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

  9. 77 FR 23485 - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-19

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

  10. 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...

  11. 78 FR 48691 - Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

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

  12. 78 FR 13072 - Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

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

  13. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. 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. PMID:23317423

  16. 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

  17. 75 FR 47308 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific 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...

  18. 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...

  19. 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,...

  20. 78 FR 38059 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... 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, 1-877-...

  1. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  2. 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...

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

    PubMed

    Williams, Christopher Ty

    2016-03-01

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

  4. 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

  5. 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...

  6. 78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-17

    ... meeting. Agenda: The committee will discuss new drug application (NDA) 205123, simeprevir (a hepatitis C... the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C) in adult patients with compensated...

  7. 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…

  8. 75 FR 65362 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-22

    ... drug applications (sNDAs) 021-319/S-024, trade name AVODART (dutasteride) Soft Gelatin Capsules... name PROSCAR (finasteride) Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk...

  9. 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...

  10. 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...