WorldWideScience

Sample records for drug administration advisory

  1. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  2. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  3. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2010-12-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...

  4. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...

  5. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...

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

    Science.gov (United States)

    2013-09-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 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...

  7. 77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  8. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  9. 78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 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...

  10. 77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  11. 75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] 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...

  12. 78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 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...

  13. 77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  14. 76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

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

    Science.gov (United States)

    2011-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

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

    Science.gov (United States)

    2010-03-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] 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...

  17. 77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] 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...

  18. 76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

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

    Science.gov (United States)

    2011-10-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  20. 76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  1. 76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 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...

  2. 75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] 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...

  3. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-04

    ...] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  4. 75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  5. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  6. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  7. 77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  8. 75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  9. 75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  10. 77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  11. 77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  12. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  13. 78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  14. 78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-04-04

    ... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...

  15. 77 FR 12063 - Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs...

    Science.gov (United States)

    2012-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...

  16. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-03-21

    ...] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... rescheduled due to the postponement of the March 7, 2013, Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee...

  17. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-02-24

    ...] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the... February 2, 2010, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be...

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

    Science.gov (United States)

    2012-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...

  19. 77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  20. 78 FR 38717 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  1. 75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  2. 77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  3. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  4. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  5. 75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  6. 75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  7. 76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  8. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  9. 75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

    Science.gov (United States)

    2010-09-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...

  10. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

  11. 75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...

  12. 77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...

  13. 75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-11-19

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committees... appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events...

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

    Science.gov (United States)

    2011-05-24

    ... committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed...] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  15. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...

  16. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and..., Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients...

  17. 75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-21

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP...

  18. 77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-12

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...., to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS...

  19. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  20. 76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee...

  1. 75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  2. 78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  3. 78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

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

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  5. 77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  6. 76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  7. 75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

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

    Science.gov (United States)

    2013-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  9. 75 FR 36427 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...

  10. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General...

  11. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Science.gov (United States)

    2013-02-25

    ...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...

  12. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Science.gov (United States)

    2011-07-29

    .... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...

  13. 76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2011-11-14

    ...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... be limited. If the number of registrants requesting to speak is greater than can be reasonably...

  14. 78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2013-01-04

    ...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated...

  15. Advisory Board on Alcoholism and Drug Abuse

    Science.gov (United States)

    State Employees Advisory Board on Alcoholism and Drug Abuse DHSS State of Alaska Home Divisions and ; Advisory Board on Alcoholism and Drug Abuse Page Content Alison Kulas Executive Director If you, a family Kulas Begins Tenure as Executive Director The Advisory Board on Alcoholism and Drug Abuse, The Alaska

  16. 77 FR 69869 - National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug...

    Science.gov (United States)

    2012-11-21

    ... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board... Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National...: National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and...

  17. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Science.gov (United States)

    2011-10-14

    ...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...

  18. 76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

    Science.gov (United States)

    2011-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the Arthritis Advisory...

  19. 75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  20. 76 FR 42715 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  1. 77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  2. 77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  3. 78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  4. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-28

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...

  5. 77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-26

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff, Food and Drug Administration, 10903...

  6. 77 FR 62242 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-12

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Person: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration...

  7. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-24

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

  8. 78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-23

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

  9. 76 FR 59142 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143

  10. 76 FR 36930 - National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug...

    Science.gov (United States)

    2011-06-23

    ... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... given of a joint meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with...

  11. 75 FR 80059 - Advisory Committees; Tentative Schedule of Meetings for 2011

    Science.gov (United States)

    2010-12-21

    .... Drugs Advisory Committee. Advisory Committee for Pharmaceutical March 2. Science and Clinical.... Science Board to the Food and Drug February 25, May 20, August 19, Administration. November 10. CENTER FOR... CENTER FOR TOXICOLOGICAL RESEARCH Science Advisory Board November 9-10. Dated: December 16, 2010. Jill...

  12. 76 FR 40735 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-07-11

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...

  13. 78 FR 2677 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-01-14

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...

  14. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...

  15. 78 FR 16271 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-03-14

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...

  16. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-30

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee..., the committee will discuss the Assessment of SpondyloArthritis international Society classification...

  17. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-12

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had...

  18. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-19

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  19. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... indication: ``ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to...

  20. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-04-06

    ...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

  1. 76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-22

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...

  2. 75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-26

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...

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

    Science.gov (United States)

    2010-04-01

    ... employees, but are reimbursed by the Food and Drug Administration for travel expenses. (b) Notwithstanding... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  4. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-10-26

    ...] Risk Communication Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register... Communication Advisory Committee would be held on November 8 and 9, 2010. On page 57280, in the first column...

  5. 75 FR 75681 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-06

    ...] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The...

  6. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

  7. 76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports

    Science.gov (United States)

    2011-01-31

    ...] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION... Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA...), FDA has filed with the Library of Congress the annual reports for the following FDA advisory...

  8. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...

  9. Using long-acting beta2-agonists safely: What will be the impact of the US Food and Drug Administration's panel recommendations?

    Science.gov (United States)

    Smart, Brian A

    2009-01-01

    The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.

  10. 75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... previously issued communications, emphasizing communications challenges. Examples, selected for illustrative...

  11. 75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

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

    Science.gov (United States)

    2011-08-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

  13. 76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

  14. 78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-03-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of...

  15. 76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-21

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss implications, for strategic communication, of recent theoretical developments on information use...

  16. 75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-20

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...

  17. 78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-11-27

    ... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...

  18. 76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-23

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...

  19. 75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-20

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...

  20. 75 FR 66773 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-29

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... or, are in late stage development for an adult oncology indication. The subcommittee will consider...

  1. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-17

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... that are in development for an adult oncology indication. The subcommittee will consider and discuss...

  2. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-05

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... adult oncology indication, or in late stage development in pediatric patients with cancer. The...

  3. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... oncology indications. The subcommittee will consider and discuss issues relating to the development of each...

  4. Drug Enforcement Administration

    Science.gov (United States)

    ... de informacin confidencial --> DEA NEWS The Drug Enforcement Administration and Discovery Education name grand winner of Operation ... JUN 15 (Washington) The United States Drug Enforcement Administration, DEA Educational Foundation and Discovery Education awarded Porter ...

  5. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... the public. Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory... measures in the pediatric development plans of oncology products. The half-day session will provide an...

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

    Science.gov (United States)

    2010-05-05

    ... DEPARTMENT OF TRANSPORTATION Bureau of Transportation Statistics Research and Innovative Technology Administration Advisory Council on Transportation Statistics; Notice of Meeting AGENCY: Research... Transportation, Research and Innovative Technology Administration, Bureau of Transportation Statistics, Attention...

  7. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  8. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  9. 78 FR 34384 - The President's Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Science.gov (United States)

    2013-06-07

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-04; Docket No. 2013-0002; Sequence 19] 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...

  10. 78 FR 45200 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Science.gov (United States)

    2013-07-26

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-06; Docket No. 2013-0002; Sequence 22] 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...

  11. 78 FR 38042 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting...

    Science.gov (United States)

    2013-06-25

    ... GENERAL SERVICES ADMINISTRATION [Notice--MK-2013-05; Docket No. 2013-0002; Sequence 20] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting; Correction AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice...

  12. 78 FR 52531 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Science.gov (United States)

    2013-08-23

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-07; Docket No. 2013-0002; Sequence 24] 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...

  13. 78 FR 55079 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meetings

    Science.gov (United States)

    2013-09-09

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-08; Docket No. 2013-0002; Sequence 27] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meetings AGENCY: Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice. SUMMARY: The...

  14. 78 FR 64942 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Science.gov (United States)

    2013-10-30

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-10; Docket No. 2013-0002; Sequence 32] 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...

  15. 78 FR 35272 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Science.gov (United States)

    2013-06-12

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-05; Docket No. 2013-0002; Sequence 20] 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...

  16. 78 FR 69416 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting

    Science.gov (United States)

    2013-11-19

    ... GENERAL SERVICES ADMINISTRATION [Notice-MK-2013-11; Docket No. 2013-0002; Sequence No. 36] 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...

  17. 75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  18. 76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  19. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-07-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  20. 77 FR 41790 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-07-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  1. 77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  2. 77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  3. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  4. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., color, national origin, religion, age, or sex. (3) It is constituted and utilizes procedures designed to...

  5. 21 CFR 14.35 - Written submissions to an advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  6. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research... system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic...

  7. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Science.gov (United States)

    2011-12-30

    ...] Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. SUMMARY: As part of the Transparency...

  8. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

  9. 78 FR 69133 - Drug Enforcement Administration

    Science.gov (United States)

    2013-11-18

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., California 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered... Diversion Control, Drug Enforcement Administration. [FR Doc. 2013-27486 Filed 11-15-13; 8:45 am] BILLING...

  10. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  11. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-03-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

  12. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-11-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

  13. Pressure ulcers induced by drug administration: A new concept and report of four cases in elderly patients.

    Science.gov (United States)

    Mizokami, Fumihiro; Takahashi, Yoshiko; Hasegawa, Keiko; Hattori, Hideyuki; Nishihara, Keiji; Endo, Hidetoshi; Furuta, Katsunori; Isogai, Zenzo

    2016-04-01

    Drug-induced akinesia is a potential cause of pressure ulcers. However, pressure ulcers that are caused by drug-induced akinesia are not considered an adverse drug reaction (ADR). We propose that drug-induced pressure ulcers (DIPU) are pressure ulcers that are caused by an external force that is experienced after drug administration, and we considered resolution of these ulcers after drug discontinuation to be a supportive finding. In this report, we reviewed the medical records of pressure ulcer cases from a 300-bed hospital. Among 148 patients, four patients with pressure ulcers met the criterion for DIPU. In these cases, the suspected DIPU were related to treatment with olanzapine, fluvoxamine, valproic acid, clotiazepam, triazolam and rilmazafone. These drugs were administrated to manage the patients' behavioral and psychological symptoms that accompanied dementia. The DIPU in these patients were categorized as stage IV according to the National Pressure Ulcer Advisory Panel criteria. Discontinuation of the causal drugs led to significant improvements or complete healing of the pressure ulcers, and the patients subsequently recovered their mobility. Therefore, we propose that DIPU are potential ADR that have been overlooked in clinical practice. Thus, recognition of DIPU as an ADR may be important in preventing and appropriately managing pressure ulcers among elderly patients. © 2015 Japanese Dermatological Association.

  14. 75 FR 30109 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Science.gov (United States)

    2010-05-28

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of Open Meeting. SUMMARY: In 1998 the Internal Revenue Service established the Electronic Tax...

  15. 76 FR 12793 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Science.gov (United States)

    2011-03-08

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of open meeting. SUMMARY: In 1998 the Internal Revenue Service established the Electronic Tax...

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

    Science.gov (United States)

    2012-05-25

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of open meeting. SUMMARY: In 1998 the Internal Revenue Service established the Electronic Tax...

  17. 77 FR 70879 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Science.gov (United States)

    2012-11-27

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of open meeting. SUMMARY: In 1998, the Internal Revenue Service established the Electronic Tax...

  18. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Science.gov (United States)

    2011-09-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

  19. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...

  20. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

  1. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

  2. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

  3. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... deposits and fees required by this section are to be paid by money order, bank draft, or certified check...

  4. 76 FR 62455 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-10-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-088)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Burch, Aerospace Safety Advisory Panel Administrative Officer, National Aeronautics and Space...

  5. 78 FR 1265 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2013-01-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-001] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel..., Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...

  6. 5 CFR 724.403 - Advisory guidelines.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  7. 75 FR 61219 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2010-10-04

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-116)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...

  8. 77 FR 20489 - Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC)

    Science.gov (United States)

    2012-04-04

    ... returns, (3) tax software developers, (4) large and small business, (5) employers and payroll service... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION...

  9. 78 FR 10693 - Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC)

    Science.gov (United States)

    2013-02-14

    ... returns, (3) tax software developers, (4) large and small business, (5) employers and payroll service... DEPARTMENT OF THE TREASURY Internal Revenue Service Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC) AGENCY: Internal Revenue Service (IRS), Treasury. ACTION...

  10. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Science.gov (United States)

    2010-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] 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...

  11. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

  12. 76 FR 64122 - NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter

    Science.gov (United States)

    2011-10-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-095)] NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the Charter of the International...

  13. 76 FR 52016 - NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-08-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...

  14. 77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-12-05

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  15. 76 FR 19147 - Aerospace Safety Advisory Panel; Meeting.

    Science.gov (United States)

    2011-04-06

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.... Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  16. 78 FR 56941 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2013-09-16

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-114] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  17. 77 FR 25502 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2012-04-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel Executive Director...

  18. 77 FR 38090 - Aerospace Safety Advisory Panel; Meeting.

    Science.gov (United States)

    2012-06-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-044] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  19. 77 FR 58413 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2012-09-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-074] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  20. 75 FR 6407 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2010-02-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10- 020)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National...

  1. Administration costs of intravenous biologic drugs for rheumatoid arthritis

    OpenAIRE

    Soini, Erkki J; Leussu, Miina; Hallinen, Taru

    2013-01-01

    Background Cost-effectiveness studies explicitly reporting infusion times, drug-specific administration costs for infusions or real-payer intravenous drug cost are few in number. Yet, administration costs for infusions are needed in the health economic evaluations assessing intravenously-administered drugs. Objectives To estimate the drug-specific administration and total cost of biologic intravenous rheumatoid arthritis (RA) drugs in the adult population and to compare the obtained costs wit...

  2. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality and...: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with Parenteral...

  3. 76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

    Science.gov (United States)

    2011-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...

  4. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

  5. 78 FR 36793 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2013-06-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-068] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel..., Huntsville, AL 35805 FOR FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel...

  6. 76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-08-18

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  7. 75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2010-03-24

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...

  8. 75 FR 59747 - NASA Advisory Council; Meeting.

    Science.gov (United States)

    2010-09-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-113)] NASA Advisory Council; Meeting. AGENCY: National Aeronautics and Space Administration. ACTION: Notice of meeting. SUMMARY: In accordance... Space Administration announces a meeting of the NASA Advisory Council. DATES: Wednesday, October 6, 2010...

  9. 75 FR 14135 - U.S. Travel And Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2010-03-24

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel And Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...

  10. 75 FR 16438 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2010-04-01

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... Tourism Advisory Board (Board) will hold a meeting to discuss topics related to the travel and tourism...

  11. 75 FR 39496 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2010-07-09

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...

  12. 75 FR 80039 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2010-12-21

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...

  13. 76 FR 21703 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2011-04-18

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...

  14. 76 FR 53666 - U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2011-08-29

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...

  15. 78 FR 70623 - Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory...

    Science.gov (United States)

    2013-11-26

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2009-0203] Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory Committee AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. [[Page...

  16. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Science.gov (United States)

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

  17. [New drug development by innovative drug administration--"change" in pharmaceutical field].

    Science.gov (United States)

    Nagai, T

    1997-11-01

    New drug development can be made by providing products of higher "selectivity for the drug" for medical treatment. There are two ways for the approach to get higher "selectivity of drug": 1) discovery of new compounds with high selectivity of drug; 2) innovation of new drug administration, that is new formulation and/or method with high selectivity of drug by integration and harmonization of various hard/soft technologies. An extensive increase of biological information and advancement of surrounding science and technology may modify the situation as the latter overcomes the former in the 21 century. As the science and technology in the 21 century is said to be formed on "3H", that is, 1. hybrid; 2. hi-quality; 3. husbandry, the new drug development by innovative drug administration is exactly based on the science and technology of 3H. Its characteristic points are interdisciplinary/interfusion, international, of philosophy/ethics, and systems of hard/hard/heart. From these points of view, not only the advance of unit technology but also a revolution in thinking way should be "must" subjects. To organize this type of research well, a total research activity such as ROR (research on research) might take an important and efficient role. Here the key words are the "Optimization technology" and "Change in Pharmaceutical Fields." As some examples of new drug innovation, our trials on several topical mucosal adhesive dosage forms and parenteral administration of peptide drugs such as insulin and erythropoietin will be described.

  18. Evaluation of drug administration errors in a teaching hospital

    Directory of Open Access Journals (Sweden)

    Berdot Sarah

    2012-03-01

    Full Text Available Abstract Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds. A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors with one or more errors were detected (27.6%. There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501. The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%. The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission. In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

  19. Advisory Committee Handbook.

    Science.gov (United States)

    Black Hawk Coll., Moline, IL.

    An advisory committee is generally comprised of persons outside the education profession who have specialized knowledge in a given area. The committee advises, makes recommendations, and gives service to the college and its students, instructors, and administrators. At Black Hawk College, there are four types of advisory committees: community,…

  20. [Evaluation of administration errors of injectable drugs in neonatology].

    Science.gov (United States)

    Cherif, A; Sayadi, M; Ben Hmida, H; Ben Ameur, K; Mestiri, K

    2015-11-01

    Use of injectable drugs in newborns represents more than 90% of prescriptions and requires special precautions in order to ensure more safety and efficiency. The aim of this study is to gather errors relating to the administration of injectable drugs and to suggest corrective actions. This descriptive and transversal study has evaluated 300 injectable drug administrations in a neonatology unit. Two hundred and sixty-one administrations have contained an error. Data are collected by direct observations of administrative act. Errors observed are: an inappropriate mixture (2.6% of cases); an incorrect delivery rate (33.7% of cases); incorrect dilutions (26.7% of cases); error in calculation of the dose to be injected (16.7% of cases); error while sampling small volumes (6.3% of cases); error or omission of administration schedule (1% of cases). These data have enabled us to evaluate administration of injectable drugs in neonatology. Different types of errors observed could be a source of therapeutic inefficiency, extended lengths of stay or iatrogenic drug. Following these observations, corrective actions have been undertaken by pharmacists and consist of: organizing training sessions for nursing; developing an explanatory guide for dilution and administration of injectable medicines, which was made available to the clinical service. Collaborative strategies doctor-nurse-pharmacist can help to reduce errors in the medication process especially during his administration. It permits improvement of injectable drugs use, offering more security and better efficiency and contribute to guarantee ideal therapy for patients. Copyright © 2015. Published by Elsevier Masson SAS.

  1. Rectal drug administration: clinical pharmacokinetic considerations.

    Science.gov (United States)

    de Boer, A G; Moolenaar, F; de Leede, L G; Breimer, D D

    1982-01-01

    The human rectum represents a body cavity in which drugs can be easily introduced and retained and from which absorption is well possible. There are important therapeutic reasons why it is sometimes preferable to give a drug rectally rather than orally, e.g. in cases of nausea and vomiting. Drawbacks of rectal drug administration include the interruption of absorption by defaecation and lack of patient acceptability. The mechanism of drug absorption from the rectum is probably no different to that in the upper part of the gastrointestinal tract, despite the fact that the physiological circumstances (e.g. pH, fluid content) differ substantially, Absorption from aqueous and alcoholic solutions may occur very rapidly, which has proved to be of considerable therapeutic value in the rapid suppression of acute convulsive attacks by diazepam (e.g. in children), but absorption from suppositories is generally slower and very much dependent on the nature of the suppository base, the use of surfactants or other additives, particle size of the active ingredient, etc. There is some evidence that hepatic first-pass elimination of high clearance drugs is partially avoided after rectal administration, e.g. lignocaine. This can be explained by the rectal venous blood supply: the upper part is connected with the portal system, whereas the lower part is directly connected with the systemic circulation. Plasma concentration data following rectal administration of representatives of several classes of drugs are reviewed: anticonvulsants, non-narcotic analgesics and non-steroidal anti-inflammatory agents, hypnosedatives and anaesthetics, strong analgesics, theophylline and derivatives, corticosteroids, antibacterial agents, thiazinamium, promethazine, hyoscine-N-butyl-bromide, streptokinase, progesterone, ergotamine tartrate and levodopa. Only limited number of cases has it been adequately shown that the rectal route of administration gives plasma concentrations which are comparable to

  2. 78 FR 41804 - NASA Advisory Council; Meeting.

    Science.gov (United States)

    2013-07-11

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-077)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday, July 31... ADDRESSES: NASA Headquarters, Room 9H40, Program Review Center, 300 E Street SW., Washington, DC 20456 FOR...

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

    Science.gov (United States)

    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

  4. [Innovative therapeutic strategies for intravesical drug administration].

    Science.gov (United States)

    Moch, C; Salmon, D; Rome, P; Marginean, R; Pivot, C; Colombel, M; Pirot, F

    2013-05-01

    Perspectives for innovative pharmaceutical molecules and intravesical administration of pharmacological agents are presented in the present review carried out from a recent literature. This review of the literature was built by using the PubMed and ScienceDirect databases running 20keywords revealing 34publications between 1983 and 2012. The number of referenced articles on ScienceDirect has increased in recent years, highlighting the interest of scientists for intravesical drug administration and the relevance of innovating drug delivery systems. Different modalities of intravesical administration using physical (e.g., iontophoresis, electroporation) or chemical techniques (e.g., enzyme, solvent, nanoparticles, liposomes, hydrogels) based on novel formulation methods are reported. Finally, the development of biopharmaceuticals (e.g., bacillus Calmette-Guérin, interferon α) and gene therapies is also presented and analyzed in this review. The present review exhibits new development in the pipeline for emerging intravesical drug administration strategies. Knowledge of all these therapies allows practitioners to propose a specific and tailored treatment to each patient with limiting systemic side effects. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  5. 38 CFR 52.180 - Administration of drugs.

    Science.gov (United States)

    2010-07-01

    ... 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 for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  6. Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

    Science.gov (United States)

    Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

    The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

  7. 76 FR 4133 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2011-01-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-007)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, February 10, 2011, 8 a.m.-5 p.m., Local Time. Friday, February 11, 2011, 8 a.m.-12 p.m., Local Time. ADDRESSES: NASA...

  8. 75 FR 5629 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2010-02-03

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-019)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, February 18, 2010, 9 a.m.-5 p.m. EST; Friday, February 19, 2010, 9 a.m.-1 p.m., EST. ADDRESSES: NASA Headquarters...

  9. 75 FR 36697 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2010-06-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-071)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel..., Room 116, Hampton, VA 23681. FOR FURTHER INFORMATION CONTACT: Ms. Kathy Dakon, Aerospace Safety...

  10. 77 FR 9997 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2012-02-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-016)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Thursday, March 8, 2012, 8 a.m.-5 p.m., local time and Friday, March 9, 2012, 8 a.m.-12 p.m., local time. ADDRESSES: NASA...

  11. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-03-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  12. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  13. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  14. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-10-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  15. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  16. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  17. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-07-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  18. 76 FR 23339 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-04-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-043)] Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting... Register of April 6, 2011, announcing a meeting of the Aerospace Safety Advisory Panel (ASAP) to take place...

  19. 76 FR 67482 - NASA Advisory Council; Charter Renewal

    Science.gov (United States)

    2011-11-01

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-108)] NASA Advisory Council; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Advisory Council. SUMMARY: Pursuant to sections 14(b)(1) and 9(c) of...

  20. 78 FR 66964 - NASA Advisory Council; Charter Renewal

    Science.gov (United States)

    2013-11-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-130)] NASA Advisory Council; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Advisory Council. SUMMARY: Pursuant to sections 14(b)(1) and 9(c) of...

  1. 75 FR 52375 - NASA Advisory Council; Exploration Committee

    Science.gov (United States)

    2010-08-25

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-094)] NASA Advisory Council... National Aeronautics and Space Administration announces a meeting of the Exploration Committee of the NASA Advisory Council. DATES: Tuesday, September 21, 2010, 1 p.m.-6:30 p.m., Local Time. ADDRESSES: NASA...

  2. 76 FR 12972 - Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory...

    Science.gov (United States)

    2011-03-09

    ....gov . Submit written comments to the Division of Dockets Management, Food and Drug Administration... be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday... telephone number is 301- 589-5200. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research...

  3. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

  4. 76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012

    Science.gov (United States)

    2011-12-20

    ..., April 30, May 1, August 16-17, November 1-2. Science Board to FDA January 6, May 2, October 3. CENTER... Date(s), if needed, to be Drugs Advisory Committee. determined. Advisory Committee for Pharmaceutical March 14. Science and Clinical Pharmacology. Psychopharmacologic Drugs Advisory Date(s), if needed, to...

  5. 76 FR 12211 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-03-04

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference (COMSTAC). SUMMARY: Pursuant...

  6. 76 FR 82031 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2011-12-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Risk Management Working Group Teleconference...

  7. 76 FR 4743 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-01-26

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  8. 75 FR 51332 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2010-08-19

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  9. 77 FR 48585 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2012-08-14

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  10. 78 FR 53496 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  11. 76 FR 15041 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-03-18

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  12. 76 FR 67018 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-10-28

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  13. 75 FR 38866 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2010-07-06

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  14. 78 FR 14401 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2013-03-05

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  15. 77 FR 35102 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2012-06-12

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  16. 77 FR 65443 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2012-10-26

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  17. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2010-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  18. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  19. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  20. Evaluation of drug administration errors in a teaching hospital

    OpenAIRE

    Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

    2012-01-01

    Abstract Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs...

  1. 78 FR 69885 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2013-11-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-133] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... INFORMATION CONTACT: Ms. Susan L. Minor, Executive Secretary for the Aeronautics Committee, NASA Headquarters...

  2. 76 FR 42160 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-07-18

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee--Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Space Transportation Operations Working Group of the Commercial Space Transportation Advisory...

  3. 75 FR 52058 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2010-08-24

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee-Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section 10...

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

    Science.gov (United States)

    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. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. 75 FR 19662 - Advisory Committee on Presidential Libraries Meeting

    Science.gov (United States)

    2010-04-15

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on Presidential Libraries Meeting... Records Administration (NARA) announces a meeting of the Advisory Committee on Presidential Libraries. The meeting will be held to discuss the Presidential Library program and topics related to the public-private...

  6. 76 FR 16643 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2011-03-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-024)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory.... ADDRESSES: Thursday, April 14, 2011--NASA Dryden Flight Research Center (DFRC), Lilly Drive Building 4825...

  7. 76 FR 58843 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2011-09-22

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 11-082] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... Headquarters, Washington, DC 20546, (202) 358-0566, or [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The...

  8. 78 FR 77502 - NASA Applied Sciences Advisory Committee Meeting

    Science.gov (United States)

    2013-12-23

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (13-152)] NASA Applied Sciences Advisory... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Sciences Advisory Committee.... ADDRESSES: NASA Headquarters, Room 3P40, 300 E Street SW., Washington, DC 20546. FOR FURTHER INFORMATION...

  9. 75 FR 41240 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2010-07-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-079)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory....m. to 4 p.m. (local time). ADDRESSES: NASA Glenn Research Center, Building 15, Small Dining...

  10. 75 FR 15743 - NASA Advisory Council; Exploration Committee; Meeting

    Science.gov (United States)

    2010-03-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-034)] NASA Advisory Council; Exploration... Aeronautics and Space Administration announces a meeting of the Exploration Committee of the NASA Advisory...-358-1715; [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The agenda topics for the meeting will...

  11. 78 FR 57178 - NASA Applied Sciences Advisory Committee Meeting

    Science.gov (United States)

    2013-09-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-115] NASA Applied Sciences Advisory... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Sciences Advisory Committee.... ADDRESSES: NASA Headquarters, Room 1Q39, 300 E Street SW., Washington, DC 20546. FOR FURTHER INFORMATION...

  12. 76 FR 40753 - NASA Advisory Council; Commercial Space; Meeting

    Science.gov (United States)

    2011-07-11

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-061)] NASA Advisory Council; Commercial...: In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Commercial Space Committee of the NASA...

  13. Discrete-choice modelling of patient preferences for modes of drug administration.

    Science.gov (United States)

    Tetteh, Ebenezer Kwabena; Morris, Steve; Titcheneker-Hooker, Nigel

    2017-12-01

    The administration of (biologically-derived) drugs for various disease conditions involves consumption of resources that constitutes a direct monetary cost to healthcare payers and providers. An often ignored cost relates to a mismatch between patients' preferences and the mode of drug administration. The "intangible" benefits of giving patients what they want in terms of the mode of drug delivery is seldom considered. This study aims to evaluate, in monetary terms, end-user preferences for the non-monetary attributes of different modes of drug administration using a discrete-choice experiment. It provides empirical support to the notion that there are significant benefits from developing patient-friendly approaches to drug delivery. The gross benefits per patient per unit administration is in the same order of magnitude as the savings in resource costs of administering drugs. The study argues that, as long as the underlying manufacturing science is capable, a patient-centred approach to producing drug delivery systems should be encouraged and pursued.

  14. 75 FR 17166 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2010-04-05

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-038)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... a.m. to 1 p.m.; Eastern Daylight Time. ADDRESSES: NASA Langley Research Center, Building 1219, Room...

  15. 75 FR 2892 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2010-01-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-003)] NASA Advisory Council; Science...: The National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The Meeting will be held for...

  16. 78 FR 10640 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2013-02-14

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (13-010)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory..., or [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The meeting will be open to the public up to...

  17. 78 FR 41115 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2013-07-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-074] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory... Time. ADDRESSES: NASA Headquarters, Room 7H45, 300 E Street SW., Washington, DC 20546. FOR FURTHER...

  18. 76 FR 18800 - NASA Advisory Council; Exploration Committee; Meeting.

    Science.gov (United States)

    2011-04-05

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-028)] NASA Advisory Council; Exploration... National Aeronautics and Space Administration announces a meeting of the Exploration Committee of the NASA Advisory Council. DATES: Tuesday, April 26, 2011, 1 p.m.-6 p.m., Local Time ADDRESSES: NASA Headquarters...

  19. 75 FR 14472 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2010-03-25

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-033)] NASA Advisory Council; Science...: The National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The Meeting will be held for...

  20. 75 FR 54389 - NASA Advisory Council; Science Committee; Meeting.

    Science.gov (United States)

    2010-09-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-103)] NASA Advisory Council; Science... National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The Meeting will be held for the...

  1. 77 FR 52379 - Advisory Committee on Veterans Business Affairs

    Science.gov (United States)

    2012-08-29

    ... SMALL BUSINESS ADMINISTRATION Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory Committee meeting. SUMMARY: The SBA is... Committee on Veterans Business Affairs. The meeting will be open to the public. DATES: September 10, 2012...

  2. 78 FR 70088 - Advisory Committee on Veterans Business Affairs

    Science.gov (United States)

    2013-11-22

    ... SMALL BUSINESS ADMINISTRATION Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory Committee meeting. SUMMARY: The SBA is... Committee on Veterans Business Affairs. The meeting will be open to the public. DATES: December 5, 2013 from...

  3. 75 FR 22434 - Advisory Committee on Veterans Business Affairs

    Science.gov (United States)

    2010-04-28

    ... SMALL BUSINESS ADMINISTRATION Advisory Committee on Veterans Business Affairs AGENCY: U.S. Small Business Administration. ACTION: Notice of open Federal Advisory Committee Meeting. SUMMARY: The SBA is... Committee on Veterans Business Affairs. The meeting will be open to the public. DATES: Tuesday, May 25, 2010...

  4. 78 FR 41114 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2013-07-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-075] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory... planning. DATES: Tuesday, July 30, 2013, 9:00 a.m. to 5:00 p.m.; Local Time. ADDRESSES: NASA Headquarters...

  5. 75 FR 50782 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2010-08-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-087)] NASA Advisory Council; Aeronautics... Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory..., 2010, 8 a.m. to 12:30 p.m.; Local Time. ADDRESSES: NASA Ames Conference Center, Building 3, 500...

  6. 76 FR 32390 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2011-06-06

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee (MCSAC) Meeting. SUMMARY...

  7. 77 FR 46555 - Motor Carrier Safety Advisory Committee: Public Meeting

    Science.gov (United States)

    2012-08-03

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee: Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of meeting of Motor Carrier Safety Advisory Committee (MCSAC...

  8. 75 FR 2923 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-01-19

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA...

  9. 75 FR 29384 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-05-25

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee meeting. SUMMARY: FMCSA...

  10. 75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-11-26

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces...

  11. 75 FR 50797 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-08-17

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA...

  12. 21 CFR 20.2 - Production of records by Food and Drug Administration employees.

    Science.gov (United States)

    2010-04-01

    ... upon an officer or employee of the Food and Drug Administration commanding the production of any record... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  13. 77 FR 4370 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2012-01-27

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-006)] NASA Advisory Council; Commercial... meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Commercial Space...

  14. 77 FR 20852 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2012-04-06

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-027)] NASA Advisory Council; Commercial... Meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Commercial Space...

  15. 78 FR 20357 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2013-04-04

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-037] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory...:30 a.m. to 3:00 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street SW., Room 6H45...

  16. 76 FR 41824 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2011-07-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-068)] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory..., 2011, 7:30 a.m. to 11:30 a.m., Local Time. ADDRESSES: NASA Ames Research Center, NASA Ames Conference...

  17. 77 FR 38093 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2012-06-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-046] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory.... to 2:30 p.m., local time. ADDRESSES: NASA Goddard Space Flight Center (GSFC), Building 1, Room E100E...

  18. 76 FR 17158 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2011-03-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-026)] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory....m. to 2 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street, SW., Room 5H45, Washington, DC...

  19. 78 FR 67202 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2013-11-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-131] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory..., 2013, 8:30 a.m. to 3:00 p.m., Local Time. ADDRESSES: This meeting will take place at NASA Headquarters...

  20. Federal Advisory Committee Act (FACA) Database-Complete-Raw

    Data.gov (United States)

    General Services Administration — The Federal Advisory Committee Act (FACA) database is used by Federal agencies to continuously manage an average of 1,000 advisory committees government-wide. This...

  1. 75 FR 16197 - NASA Advisory Council; Space Operations Committee; Meeting

    Science.gov (United States)

    2010-03-31

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-036)] NASA Advisory Council; Space..., the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council Space Operations Committee. DATES: Tuesday, April 13, 2010, 3-5 p.m. CDT. ADDRESSES: NASA Johnson Space...

  2. 77 FR 67028 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2012-11-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-093] NASA Advisory Council; Commercial..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Commercial Space Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The [[Page 67029

  3. 76 FR 3673 - NASA Advisory Council; Space Operations Committee; Meeting.

    Science.gov (United States)

    2011-01-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-005)] NASA Advisory Council; Space..., the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council.... ADDRESSES: NASA Headquarters, 300 E Street, SW., Room 7C61, Washington, DC 20546. FOR FURTHER INFORMATION...

  4. 77 FR 6824 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2012-02-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-010] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory....m. to 2 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street SW., Room 3H46 and 7H45...

  5. 76 FR 59446 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2011-09-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice11-084] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory..., 2011, 8:30 a.m. to 2 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street, SW., Room 3H46...

  6. 75 FR 35091 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2010-06-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-068)] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory....m. to 1:30 p.m., e.d.t. ADDRESSES: NASA Headquarters, 300 E Street, SW., Room 3H46, Washington, DC...

  7. Transparency in Canadian public drug advisory committees.

    Science.gov (United States)

    Rosenberg-Yunger, Zahava R S; Bayoumi, Ahmed M

    2014-11-01

    Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached. We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence. Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  8. 78 FR 10213 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2013-02-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-012] NASA Advisory Council; Commercial..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Commercial Space Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held...

  9. 77 FR 38678 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2012-06-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-052)] NASA Advisory Council; Commercial..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Commercial Space Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held...

  10. 78 FR 42111 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2013-07-15

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-080)] NASA Advisory Council; Commercial..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Commercial Space Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held...

  11. 75 FR 70031 - Advisory Committee on the Records of Congress

    Science.gov (United States)

    2010-11-16

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Records of Congress AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the... meeting of the Advisory Committee on the Records of Congress. The committee advises NARA on the full range...

  12. 76 FR 31367 - Advisory Committee on the Records of Congress

    Science.gov (United States)

    2011-05-31

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Records of Congress AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the... meeting of the Advisory Committee on the Records of Congress. The committee advises NARA on the full range...

  13. 75 FR 32229 - Advisory Committee on the Records of Congress

    Science.gov (United States)

    2010-06-07

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Records of Congress AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the... meeting of the Advisory Committee on the Records of Congress. The committee advises NARA on the full range...

  14. 76 FR 8380 - NASA Advisory Council; Science Committee; Meeting

    Science.gov (United States)

    2011-02-14

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-114)] NASA Advisory Council; Science... Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory...:30 a.m. to 2 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street, SW., Rooms 9H40 and 3H46...

  15. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date; reopening of administrative record. Food and Drug Administration, HHS. Final rule; delay of effective date; reopening of administrative record.

    Science.gov (United States)

    2000-05-03

    The Food and Drug Administration (FDA) is delaying until October 1, 2001, the effective date and reopening the administrative record to receive additional comments regarding certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The other provisions of the final rule become effective on December 4, 2000. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). FDA is delaying the effective date for certain requirements relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record. FDA is also delaying the effective date of another requirement that would prohibit blood centers functioning as "health care entities" to act as wholesale distributors of blood derivatives. The agency is taking this action to address numerous concerns about the provisions raised by affected parties.

  16. 78 FR 16045 - Safety Advisory: Unauthorized Marking of Compressed Gas Cylinders

    Science.gov (United States)

    2013-03-13

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2013-0019; Notice No. 13-03] Safety Advisory: Unauthorized Marking of Compressed Gas Cylinders AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Safety Advisory...

  17. 78 FR 57903 - Aerospace Safety Advisory Panel; Charter Renewal

    Science.gov (United States)

    2013-09-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-116] Aerospace Safety Advisory Panel... and amendment of the charter of the Aerospace Safety Advisory Panel. SUMMARY: Pursuant to sections 14... determined that renewal and amendment of the charter of the Aerospace Safety Advisory Panel is in the public...

  18. 76 FR 65750 - Aerospace Safety Advisory Panel; Charter Renewal

    Science.gov (United States)

    2011-10-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-105)] Aerospace Safety Advisory Panel... and amendment of the charter of the NASA Aerospace Safety Advisory Panel. SUMMARY: Pursuant to... determined that a renewal and amendment of the charter of the NASA Aerospace Safety Advisory Panel is in the...

  19. 75 FR 55616 - NASA Advisory Council; Information Technology Infrastructure Committee; Meeting

    Science.gov (United States)

    2010-09-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-110)] NASA Advisory Council...-463, as amended, the National Aeronautics and Space Administration (NASA) announce a meeting for the Information Technology Infrastructure Committee of the NASA Advisory Council (NAC). DATES: Tuesday, September...

  20. 76 FR 5424 - Motor Carrier Safety Advisory Committee; Request for Nominations

    Science.gov (United States)

    2011-01-31

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee; Request for Nominations AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Request for Nominations to the Motor Carrier Safety Advisory...

  1. 75 FR 11200 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2010-03-10

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-025)] NASA Advisory Council; Commercial... Committee of the NASA Advisory Council. DATES: Tuesday, March 30, 2010, 1 p.m.-5 p.m., EST. ADDRESSES: NASA... Administration, Washington, DC, 20546. Phone 202-358-1686, fax: 202-358-3878, [email protected]nasa.gov...

  2. 75 FR 28821 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2010-05-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-060)] NASA Advisory Council; Commercial... Committee of the NASA Advisory Council. DATES: Thursday, June 17, 2010, 1 p.m.-4 p.m., EDST. ADDRESSES: NASA... Space Administration, Washington, DC 20546. Phone 202- 358-1686, fax: 202-358-3878, [email protected]nasa...

  3. 78 FR 76599 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2013-12-18

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy..., General Services Administration, notice is hereby given that the Nuclear Energy Advisory Committee (NEAC... to the Department of Energy's Office of Nuclear Energy on complex science and technical issues that...

  4. Accuracy of manual entry of drug administration data into an anesthesia information management system.

    Science.gov (United States)

    Avidan, Alexander; Dotan, Koren; Weissman, Charles; Cohen, Matan J; Levin, Phillip D

    2014-11-01

    Data on drug administration are entered manually into anesthesia information management systems (AIMS). This study examined whether these data are accurate regarding drug name, dose administered, and time of administration, and whether the stage of anesthesia influences data accuracy. Real-time observational data on drug administration during elective operations were compared with computerized information on drug administration entered by anesthesiologists. A trained observer (K.D.) performed the observations. Data were collected during 57 operations which included 596 separate occasions of drug administration by 22 anesthesiologists. No AIMS records were found for 90 (15.1%) occasions of drug administration (omissions), while there were 11 (1.8%) AIMS records where drug administration was not observed. The AIMS and observer data matched for drug name on 495 of 596 (83.1%) occasions, for dose on 439 of 495 (92.5%) occasions, and for time on 476 of 495 (96.2%) occasions. Amongst the 90 omitted records, 34 (37.8%) were for vasoactive drugs with 24 (27.7%) for small doses of hypnotics. Omissions occurred mostly during maintenance: 50 of 153 (24.6%), followed by induction: 30 of 325 (9.2%) and emergence: 10 of 57 (17.5%) (P < 0.001). Time and dose inaccuracies occurred mainly during induction, followed by maintenance and emergence; time inaccuracies were 7/325 (8.3%), 10/203 (4.9%), and 0/57 (0%), respectively (P = 0.07), and dose inaccuracies were 15/325 (4.6%), 3/203 (1.5%), and 1/57 (1.7%), respectively (P = 0.11). The range of accuracy varies when anesthesiologists manually enter drug administration data into an AIMS. Charting omissions represent the largest cause of inaccuracy, principally by omissions of records for vasopressors and small doses of hypnotic drugs. Manually entered drug administration data are not without errors. Accuracy of entering drug administration data remains the responsibility of the anesthesiologist.

  5. 75 FR 74089 - NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting

    Science.gov (United States)

    2010-11-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-149)] NASA Advisory Council; Science... amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC...

  6. 77 FR 64561 - NASA Advisory Council; Technology and Innovation Committee; Meeting

    Science.gov (United States)

    2012-10-22

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-083] NASA Advisory Council; Technology...: Notice of meeting. SUMMARY: The National Aeronautics and Space Administration (NASA) announces a meeting of the Technology and Innovation Committee of the NASA Advisory Council (NAC). The meeting will be...

  7. 77 FR 71019 - Advisory Committee on the Records of Congress; Meeting

    Science.gov (United States)

    2012-11-28

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Advisory Committee on the Records of Congress; Meeting AGENCY: National Archives and Records Administration. ACTION: Notice of meeting. SUMMARY: In...) announces a meeting of the Advisory Committee on the Records of Congress. The committee advises NARA on the...

  8. 78 FR 39341 - NASA Advisory Council; Science Committee; Planetary Science Subcommittee; Meeting.

    Science.gov (United States)

    2013-07-01

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-070] NASA Advisory Council; Science..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This [[Page 39342

  9. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Science.gov (United States)

    2010-04-28

    ... Selection Process--the criteria a contract organization should use to consider saying no to a contract... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Outsourcing Conference AGENCY: Food and Drug...

  10. Hierarchical pulmonary target nanoparticles via inhaled administration for anticancer drug delivery.

    Science.gov (United States)

    Chen, Rui; Xu, Liu; Fan, Qin; Li, Man; Wang, Jingjing; Wu, Li; Li, Weidong; Duan, Jinao; Chen, Zhipeng

    2017-11-01

    Inhalation administration, compared with intravenous administration, significantly enhances chemotherapeutic drug exposure to the lung tissue and may increase the therapeutic effect for pulmonary anticancer. However, further identification of cancer cells after lung deposition of inhaled drugs is necessary to avoid side effects on normal lung tissue and to maximize drug efficacy. Moreover, as the action site of the major drug was intracellular organelles, drug target to the specific organelle is the final key for accurate drug delivery. Here, we designed a novel multifunctional nanoparticles (MNPs) for pulmonary antitumor and the material was well-designed for hierarchical target involved lung tissue target, cancer cell target, and mitochondrial target. The biodistribution in vivo determined by UHPLC-MS/MS method was employed to verify the drug concentration overwhelmingly increasing in lung tissue through inhaled administration compared with intravenous administration. Cellular uptake assay using A549 cells proved the efficient receptor-mediated cell endocytosis. Confocal laser scanning microscopy observation showed the location of MNPs in cells was mitochondria. All results confirmed the intelligent material can progressively play hierarchical target functions, which could induce more cell apoptosis related to mitochondrial damage. It provides a smart and efficient nanocarrier platform for hierarchical targeting of pulmonary anticancer drug. So far, this kind of material for pulmonary mitochondrial-target has not been seen in other reports.

  11. 75 FR 4110 - NASA Advisory Council; Technology and Innovation Committee; Meeting.

    Science.gov (United States)

    2010-01-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-010)] NASA Advisory Council; Technology... amended, the National Aeronautics and Space Administration (NASA) announce a meeting of the newly formed Technology and Innovation Committee of the NASA Advisory Council (NAC). This will be the first meeting of...

  12. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Science.gov (United States)

    2010-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

  13. Systematic review of drug administration costs and implications for biopharmaceutical manufacturing.

    Science.gov (United States)

    Tetteh, Ebenezer; Morris, Stephen

    2013-10-01

    The acquisition costs of biologic drugs are often considered to be relatively high compared with those of nonbiologics. However, the total costs of delivering these drugs also depend on the cost of administration. Ignoring drug administration costs may distort resource allocation decisions because these affect cost effectiveness. The objectives of this systematic review were to develop a framework of drug administration costs that considers both the costs of physical administration and the associated proximal costs; and, as a case example, to use this framework to evaluate administration costs for biologics within the UK National Health Service (NHS). We reviewed literature that reported estimates of administration costs for biologics within the UK NHS to identify how these costs were quantified and to examine how differences in dosage forms and regimens influenced administration costs. The literature reviewed were identified by searching the Centre for Review and Dissemination Databases (DARE, NHS EED and HTA); EMBASE (The Excerpta Medica Database); MEDLINE (using the OVID interface); Econlit (EBSCO); Tufts Medical Center Cost Effectiveness Analysis (CEA) Registry; and Google Scholar. We identified 4,344 potentially relevant studies, of which 43 studies were selected for this systematic review. We extracted estimates of the administration costs of biologics from these studies. We found evidence of variation in the way that administration costs were measured, and that this affected the magnitude of costs reported, which could then influence cost effectiveness. Our findings suggested that manufacturers of biologic medicines should pay attention to formulation issues and their impact on administration costs, because these affect the total costs of healthcare delivery and cost effectiveness.

  14. 76 FR 50179 - U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2011-08-12

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board... to apply for membership on the U.S. Travel and Tourism Advisory Board. SUMMARY: The Department of Commerce is currently seeking applications for membership on the U.S. Travel and Tourism Advisory Board...

  15. 75 FR 80082 - State, Local, Tribal, and Private Sector Policy Advisory Committee

    Science.gov (United States)

    2010-12-21

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION State, Local, Tribal, and Private Sector Policy Advisory Committee AGENCY: National Archives and Records Administration. ACTION: Notice of Establishment of... that the establishment of the State, Local, Tribal, and Private Sector Policy Advisory Committee is...

  16. 75 FR 8997 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Meeting

    Science.gov (United States)

    2010-02-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-021)] NASA Advisory Council; Science...: Notice of meeting. SUMMARY: The National Aeronautics and Space Administration (NASA) announces a meeting of the Earth Science Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to...

  17. 78 FR 21421 - NASA Advisory Council; Science Committee; Planetary Protection Subcommittee; Meeting

    Science.gov (United States)

    2013-04-10

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-048] NASA Advisory Council; Science...-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Protection Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the...

  18. 76 FR 69292 - NASA Advisory Council Science Committee Planetary Science Subcommittee; Meeting

    Science.gov (United States)

    2011-11-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 11-113] NASA Advisory Council Science..., Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces that the meeting of the Planetary Science Subcommittee of the NASA Advisory Council originally scheduled...

  19. 78 FR 21977 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

    Science.gov (United States)

    2013-04-12

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and Health Administration (OSHA), Labor... Maritime Advisory Committee for Occupational Safety and Health. The Committee will better enable OSHA to...

  20. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Compliance with Food and Drug Administration requirements. 17.136 Section 17.136 Alcohol, Tobacco Products and Firearms ALCOHOL... Compliance with Food and Drug Administration requirements. A product is not a medicine, medicinal preparation...

  1. 5 CFR 591.243 - How many members are on each COLA Advisory Committee?

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false How many members are on each COLA Advisory Committee? 591.243 Section 591.243 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL... Areas Program Administration § 591.243 How many members are on each COLA Advisory Committee? A COLA...

  2. 76 FR 49757 - Fusion Energy Sciences Advisory Committee

    Science.gov (United States)

    2011-08-11

    ... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Office of Science... Services Administration, notice is hereby given that the Fusion Energy Sciences Advisory Committee will be... science, fusion science, and fusion technology related to the Fusion Energy Sciences program. Additionally...

  3. Common errors of drug administration in infants: causes and avoidance.

    Science.gov (United States)

    Anderson, B J; Ellis, J F

    1999-01-01

    Drug administration errors are common in infants. Although the infant population has a high exposure to drugs, there are few data concerning pharmacokinetics or pharmacodynamics, or the influence of paediatric diseases on these processes. Children remain therapeutic orphans. Formulations are often suitable only for adults; in addition, the lack of maturation of drug elimination processes, alteration of body composition and influence of size render the calculation of drug doses complex in infants. The commonest drug administration error in infants is one of dose, and the commonest hospital site for this error is the intensive care unit. Drug errors are a consequence of system error, and preventive strategies are possible through system analysis. The goal of a zero drug error rate should be aggressively sought, with systems in place that aim to eliminate the effects of inevitable human error. This involves review of the entire system from drug manufacture to drug administration. The nuclear industry, telecommunications and air traffic control services all practise error reduction policies with zero error as a clear goal, not by finding fault in the individual, but by identifying faults in the system and building into that system mechanisms for picking up faults before they occur. Such policies could be adapted to medicine using interventions both specific (the production of formulations which are for children only and clearly labelled, regular audit by pharmacists, legible prescriptions, standardised dose tables) and general (paediatric drug trials, education programmes, nonpunitive error reporting) to reduce the number of errors made in giving medication to infants.

  4. 75 FR 4875 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2010-01-29

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-015)] NASA Advisory Council; Meeting... the NASA Advisory Council. This will be the first meeting of this Committee. DATES: February 17, 2010--10 a.m.-4 p.m. (EST). ADDRESSES: NASA Headquarters, 300 E Street, SW., Washington, DC, Room CD61. FOR...

  5. 76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-11-17

    .... Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration...) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of.... This will include a discussion of the definition and scope of this indication as well as the types of...

  6. 76 FR 58303 - NASA Advisory Council; Science Committee; Planetary Science Subcommittee; Meeting.

    Science.gov (United States)

    2011-09-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-081)] NASA Advisory Council; Science...-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science...

  7. 76 FR 31641 - NASA Advisory Council; Science Committee; Planetary Science Subcommittee; Meeting

    Science.gov (United States)

    2011-06-01

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 11-050] NASA Advisory Council; Science...-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science...

  8. 78 FR 77719 - NASA Advisory Council; Science Committee; Planetary Science Subcommittee; Meeting

    Science.gov (United States)

    2013-12-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-156] NASA Advisory Council; Science...-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science...

  9. 75 FR 4588 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2010-01-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 10-011] NASA Advisory Council; Meeting... Committee of the NASA Advisory Council. This will be the first meeting of this Committee. DATES: February 11, 2010--11 a.m.-1 p.m. (EST). Meet-Me-Number: 1-877-613-3958; 2939943. ADDRESSES: NASA Headquarters, 300...

  10. A drug's life: the pathway to drug approval.

    Science.gov (United States)

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  11. 21 CFR 20.3 - Certification and authentication of Food and Drug Administration records.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Certification and authentication of Food and Drug... authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug Administration will... or for authentication of records shall be sent in writing to the Freedom of Information Staff (HFI-35...

  12. 75 FR 22168 - Region VI-Houston District; Advisory Council Meeting; Public Meeting

    Science.gov (United States)

    2010-04-27

    ... SMALL BUSINESS ADMINISTRATION Region VI--Houston District; Advisory Council Meeting; Public Meeting The Small Business Administration-Region VI--Houston Advisory Council, located in the geographical Area of Houston, Texas will hold a federal public meeting on--Thursday, May 20, 2010, starting at 10:30...

  13. 76 FR 24080 - Houston District Office Advisory Committee

    Science.gov (United States)

    2011-04-29

    ... SMALL BUSINESS ADMINISTRATION Houston District Office Advisory Committee AGENCY: U.S. Small... Houston District Office Advisory committee. The meeting will be open to the public. DATES: The meeting...; located at 8701 South Gessner, Houston, TX 77074. SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2...

  14. 76 FR 64990 - Houston District Office Advisory Committee

    Science.gov (United States)

    2011-10-19

    ... SMALL BUSINESS ADMINISTRATION Houston District Office Advisory Committee AGENCY: U.S. Small... Houston District Office Advisory committee. The meeting will be open to the public. DATES: The meeting...; located at 8701 South Gessner, Houston, TX. 77074. SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2...

  15. 78 FR 50405 - High Energy Physics Advisory Panel

    Science.gov (United States)

    2013-08-19

    ... DEPARTMENT OF ENERGY High Energy Physics Advisory Panel AGENCY: Office of Science, Department of..., General Services Administration, notice is hereby given that the High Energy Physics Advisory Panel will... Sciences Directorate (NSF), on long-range planning and priorities in the national high-energy physics...

  16. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Science.gov (United States)

    2013-05-22

    ... 24, 2013, from approximately 1 p.m. to 3:45 p.m. Location: Food and Drug Administration, White Oak..., Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, White Oak Bldg... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

  17. 76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

    Science.gov (United States)

    2011-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367

  18. 78 FR 40098 - Emerging Technology and Research Advisory Committee;

    Science.gov (United States)

    2013-07-03

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Assistant Secretary for Export Administration on emerging technology and research activities, including...

  19. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Science.gov (United States)

    2012-02-27

    ... Oversight of PET Drug Products--Questions and Answers.'' The draft guidance provides questions and answers... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... PET Drug Products--Questions and Answers.'' In 1997, Congress passed the Food and Drug Administration...

  20. 76 FR 43673 - Renewal of Department of Defense Federal Advisory Committee

    Science.gov (United States)

    2011-07-21

    ... members of the Advisory Board are the Science Advisor to the President, the Administrator of the National... National Academy of Sciences, nominate persons for appointment to the Advisory Board; b. Council of Environmental Quality nominate for appointment to the Advisory Board at least one person who is a representative...

  1. 75 FR 16204 - Region II Buffalo District Advisory Council; Public Meeting

    Science.gov (United States)

    2010-03-31

    ... SMALL BUSINESS ADMINISTRATION Region II Buffalo District Advisory Council; Public Meeting AGENCY... meeting of the Region II Buffalo District Advisory Council. The meeting will be open to the public. DATES... Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Region II Buffalo...

  2. 77 FR 20871 - Region II Buffalo District Advisory Council; Public Meeting

    Science.gov (United States)

    2012-04-06

    ... SMALL BUSINESS ADMINISTRATION Region II Buffalo District Advisory Council; Public Meeting AGENCY... meeting of the Region II Buffalo District Advisory Council. The meeting will be open to the public. DATES... Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Region II Buffalo District Advisory...

  3. 76 FR 59480 - Region II Buffalo District Advisory Council; Public Meeting

    Science.gov (United States)

    2011-09-26

    ... SMALL BUSINESS ADMINISTRATION Region II Buffalo District Advisory Council; Public Meeting AGENCY... meeting of the Region II Buffalo District Advisory Council. The meeting will be open to the public. DATES... Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Region II Buffalo...

  4. 77 FR 70788 - National Advisory Council on Migrant Health; Cancellation of Meeting

    Science.gov (United States)

    2012-11-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Migrant Health; Cancellation of Meeting Name: National Advisory Council on Migrant....m. STATUS: The meeting of the National Advisory Council on Migrant Health, scheduled for December 4...

  5. 76 FR 621 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-01-05

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation...: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section... given of a teleconference of the Commercial Space Transportation Advisory Committee (COMSTAC). The...

  6. 76 FR 41323 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-07-13

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation...: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section... given of a teleconference of the Commercial Space Transportation Advisory Committee (COMSTAC). The...

  7. 76 FR 4988 - Commercial Space Transportation Advisory Committee-Public Teleconference

    Science.gov (United States)

    2011-01-27

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation...: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section... given of a teleconference of the Commercial Space Transportation Advisory Committee (COMSTAC). The...

  8. 76 FR 78329 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2011-12-16

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation...: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section... given of a teleconference of the Commercial Space Transportation Advisory Committee (COMSTAC). The...

  9. 75 FR 65362 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-22

    ... Hampshire Ave., Silver Spring, MD 20993-0002. Information regarding special accommodations due to a... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver...) Soft Gelatin Capsules, [[Page 65363

  10. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Science.gov (United States)

    2013-03-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  11. 77 FR 20871 - Audit and Financial Management Advisory (AFMAC)

    Science.gov (United States)

    2012-04-06

    ... SMALL BUSINESS ADMINISTRATION Audit and Financial Management Advisory (AFMAC) AGENCY: U.S. Small... Financial Management Advisory (AFMAC). The meeting will be open to the public. DATES: The meeting will be... Agency's financial management, including the financial reporting process, systems of internal controls...

  12. 78 FR 41496 - Pipeline Safety: Meetings of the Gas and Liquid Pipeline Advisory Committees

    Science.gov (United States)

    2013-07-10

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2013-0156] Pipeline Safety: Meetings of the Gas and Liquid Pipeline Advisory Committees AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of advisory committee...

  13. 78 FR 27974 - National Advisory Council on Migrant Health; Cancellation of Meeting

    Science.gov (United States)

    2013-05-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Migrant Health; Cancellation of Meeting Name: National Advisory Council on Migrant.... Status: The meeting of the National Advisory Council on Migrant Health, scheduled for May 21 and 22, 2013...

  14. 75 FR 69920 - (NOAA) Science Advisory Board (SAB)

    Science.gov (United States)

    2010-11-16

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration (NOAA) Science Advisory... Administration (NOAA), Department of Commerce (DOC). ACTION: Notice of open meeting. SUMMARY: The Science... Administration (NOAA) science programs are of the highest quality and provide optimal support to resource...

  15. 78 FR 16254 - (NOAA) Science Advisory Board (SAB)

    Science.gov (United States)

    2013-03-14

    ... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration (NOAA) Science Advisory... Administration (NOAA), Department of Commerce (DOC). ACTION: Notice of open meeting. SUMMARY: The Science... Administration (NOAA) science programs are of the highest quality and provide optimal support to resource...

  16. Adverse Drug Events caused by Serious Medication Administration Errors

    Science.gov (United States)

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

    2013-01-01

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

  17. Adverse Drug Reactions Related to Drug Administration in Hospitalized Patients.

    Science.gov (United States)

    Gallelli, Luca; Siniscalchi, Antonio; Palleria, Caterina; Mumoli, Laura; Staltari, Orietta; Squillace, Aida; Maida, Francesca; Russo, Emilio; Gratteri, Santo; De Sarro, Giovambattista

    2017-01-01

    Drug treatment may be related to the development of adverse drug reactions (ADRs). In this paper, we evaluated the ADRs in patients admitted to Catanzaro Hospital. After we obtained the approval by local Ethical Committee, we performed a retrospective study on clinical records from March 01, 2013 to April 30, 2015. The association between drug and ADR or between drug and drug-drug-interactions (DDIs) was evaluated using the Naranjo's probability scale and Drug Interaction Probability Scale (DIPS), respectively. During the study period, we analyzed 2870 clinical records containing a total of 11,138 prescriptions, and we documented the development of 770 ADRs. The time of hospitalization was significantly higher (P<0.05) in women with ADRs (12.6 ± 1.2 days) with respect to men (11.8± 0.83 days). Using the Naranjo score, we documented a probable association in 78% of these reactions, while DIPS revealed that about 22% of ADRs were related to DDIs. Patients with ADRs received 3052 prescriptions on 11,138 (27.4%) having a mean of 6.1±0.29 drugs that was significantly higher (P<0.01) with respect to patients not experiencing ADRs (mean of 3.4±0.13 drugs). About 19% of ADRs were not diagnosed and were treated as new diseases. Our results indicate that drug administration induces the development of ADRs also during the hospitalization, particularly in elderly women. Moreover, we also documented that ADRs in some patients are under-diagnosed, therefore, it is important to motivate healthcare to report the ADRs in order to optimize the patients' safety. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. 76 FR 4412 - Commercial Space Transportation Advisory Committee-Closed Session

    Science.gov (United States)

    2011-01-25

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Special Closed Session. SUMMARY: Pursuant to Section 10(a... Commercial Space Transportation Advisory Committee (COMSTAC). The special closed session will be an...

  19. 76 FR 28046 - Memorandum of Understanding Between the Food and Drug Administration and the International...

    Science.gov (United States)

    2011-05-13

    ... Tots Public-Private Partnership AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0005; FDA 225-09-0014] Memorandum of Understanding Between the Food and Drug Administration and the...

  20. 78 FR 20666 - Food and Drug Administration/National Institutes of Health/National Science Foundation Public...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0345] Food and Drug Administration/National Institutes of Health/ National Science Foundation Public Workshop... public workshop; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing its...

  1. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  2. 78 FR 77501 - NASA Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2013-12-23

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-153] NASA Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of Meeting...

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

    Science.gov (United States)

    2013-01-03

    ... Dependence; Public Hearing; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; Extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No...

  4. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Science.gov (United States)

    2013-03-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  5. 76 FR 183 - NASA Advisory Council; Aeronautics Committee; Meeting

    Science.gov (United States)

    2011-01-03

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-172)] NASA Advisory Council... the NASA Advisory Council. The meeting will be held for the purpose of soliciting from the aeronautics... 20546, (202) 358-0566, or [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The meeting will be open...

  6. 78 FR 16357 - Research, Engineering and Development Advisory Committee

    Science.gov (United States)

    2013-03-14

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development... hereby given of a meeting of the FAA Research, Engineering and Development (R,E&D) Advisory Committee. Name: Research, Engineering & Development Advisory Committee. Time and Date: April 24--8:30 a.m. to 4...

  7. 78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

    Science.gov (United States)

    2013-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0365] Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of...

  8. 78 FR 70093 - Commercial Space Transportation Advisory Committee-Closed Session

    Science.gov (United States)

    2013-11-22

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Special Closed Session. SUMMARY: Pursuant to Section 10(a...), notice is hereby given of a special closed session of the Commercial Space Transportation Advisory...

  9. 76 FR 17474 - Commercial Space Transportation Advisory Committee-Open Meeting

    Science.gov (United States)

    2011-03-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  10. 77 FR 16891 - Commercial Space Transportation Advisory Committee-Open Meeting

    Science.gov (United States)

    2012-03-22

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  11. 78 FR 53496 - Commercial Space Transportation Advisory Committee; Open Meeting

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  12. 76 FR 51461 - Commercial Space Transportation Advisory Committee-Open Meeting

    Science.gov (United States)

    2011-08-18

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee open meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  13. 78 FR 69742 - Commercial Space Transportation Advisory Committee-Open Meeting

    Science.gov (United States)

    2013-11-20

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  14. 77 FR 52108 - Commercial Space Transportation Advisory Committee; Open Meeting

    Science.gov (United States)

    2012-08-28

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  15. 75 FR 54002 - Commercial Space Transportation Advisory Committee-Open Meeting

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  16. 78 FR 53497 - Commercial Space Transportation Advisory Committee; Closed Session

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Special Closed Session. SUMMARY: Pursuant to Section 10(a...), notice is hereby given of a special closed session of the Commercial Space Transportation Advisory...

  17. 78 FR 18416 - Commercial Space Transportation Advisory Committee; Open Meeting

    Science.gov (United States)

    2013-03-26

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

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

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  19. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  20. 28 CFR 0.10 - Attorney General's Advisory Committee of U.S. Attorneys.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Attorney General's Advisory Committee of... DEPARTMENT OF JUSTICE Office of the Attorney General § 0.10 Attorney General's Advisory Committee of U.S. Attorneys. (a) The Attorney General's Advisory Committee of United States Attorneys shall consist of an...

  1. 78 FR 48855 - Renewable Energy and Energy Efficiency Advisory Committee

    Science.gov (United States)

    2013-08-12

    ... Administration Renewable Energy and Energy Efficiency Advisory Committee AGENCY: International Trade... the international competitiveness of the U.S. renewable energy and energy efficiency industries. The... Renewable Energy and Energy Efficiency Advisory Committee, Attention: Ryan Mulholland, Office of Energy and...

  2. 75 FR 16901 - Commercial Space Transportation Advisory Committee-Open Meeting

    Science.gov (United States)

    2010-04-02

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open meeting. SUMMARY: Pursuant to section 10(a)(2) of the... of the Commercial Space Transportation Advisory Committee (COMSTAC). The meetings will take place on...

  3. 77 FR 20009 - Meeting of the United States Travel and Tourism Advisory Board

    Science.gov (United States)

    2012-04-03

    ... Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION... the United States Travel and Tourism Advisory Board (Board). The agenda may change to accommodate... and Tourism Advisory Board, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone...

  4. 75 FR 80081 - NASA Advisory Council; Exploration Committee; Meeting

    Science.gov (United States)

    2010-12-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-167)] NASA Advisory Council... the NASA Advisory Council. DATES: Tuesday, January 11, 2011, 10:30 a.m.-5:45 p.m., Local Time ADDRESSES: NASA Headquarters, Glennan Conference Room-1Q39; 300 E Street, SW., Washington, DC 20546 FOR...

  5. Role of mass drug administration in elimination of Plasmodium falciparum malaria: a consensus modelling study.

    Science.gov (United States)

    Brady, Oliver J; Slater, Hannah C; Pemberton-Ross, Peter; Wenger, Edward; Maude, Richard J; Ghani, Azra C; Penny, Melissa A; Gerardin, Jaline; White, Lisa J; Chitnis, Nakul; Aguas, Ricardo; Hay, Simon I; Smith, David L; Stuckey, Erin M; Okiro, Emelda A; Smith, Thomas A; Okell, Lucy C

    2017-07-01

    Mass drug administration for elimination of Plasmodium falciparum malaria is recommended by WHO in some settings. We used consensus modelling to understand how to optimise the effects of mass drug administration in areas with low malaria transmission. We collaborated with researchers doing field trials to establish a standard intervention scenario and standard transmission setting, and we input these parameters into four previously published models. We then varied the number of rounds of mass drug administration, coverage, duration, timing, importation of infection, and pre-administration transmission levels. The outcome of interest was the percentage reduction in annual mean prevalence of P falciparum parasite rate as measured by PCR in the third year after the final round of mass drug administration. The models predicted differing magnitude of the effects of mass drug administration, but consensus answers were reached for several factors. Mass drug administration was predicted to reduce transmission over a longer timescale than accounted for by the prophylactic effect alone. Percentage reduction in transmission was predicted to be higher and last longer at lower baseline transmission levels. Reduction in transmission resulting from mass drug administration was predicted to be temporary, and in the absence of scale-up of other interventions, such as vector control, transmission would return to pre-administration levels. The proportion of the population treated in a year was a key determinant of simulated effectiveness, irrespective of whether people are treated through high coverage in a single round or new individuals are reached by implementation of several rounds. Mass drug administration was predicted to be more effective if continued over 2 years rather than 1 year, and if done at the time of year when transmission is lowest. Mass drug administration has the potential to reduce transmission for a limited time, but is not an effective replacement for existing

  6. 78 FR 77103 - United States Travel and Tourism Advisory Board

    Science.gov (United States)

    2013-12-20

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism... extended deadline for application for membership on the United States Travel and Tourism Advisory Board... Travel and Tourism Advisory Board (Board). The November 25, 2013 notice provided that all applications...

  7. 75 FR 70214 - Renewable Energy and Energy Efficiency Advisory Committee

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF COMMERCE International Trade Administration Renewable Energy and Energy Efficiency... of an open meeting. SUMMARY: The Renewable Energy and Energy Efficiency Advisory Committee (RE&EEAC... submitted to the Renewable Energy and Energy Efficiency Advisory Committee, Office of Energy and...

  8. 77 FR 27538 - Aviation Rulemaking Advisory Committee-Continuing a Task

    Science.gov (United States)

    2012-05-10

    ... Committee--Continuing a Task AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of continuing a task assignment for the Aviation Rulemaking Advisory Committee (ARAC). SUMMARY: The FAA assigned the Aviation Rulemaking Advisory Committee (ARAC) a continuing task to provide advice and...

  9. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco, Firearms, and Explosives, Bureau of Prisons, Federal... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of...

  10. KZHU Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  11. KZOA Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  12. KZJX Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  13. KZBW Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  14. KZFW Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  15. KZSE Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  16. KZME Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  17. KZDV Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  18. KZNY Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  19. KZDC Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  20. KZAU Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  1. Effect of intravenous drug administration mode on drug distribution in a tumor slab: a finite Fourier transform analysis.

    Science.gov (United States)

    Subramaniam, B; Claudius, J S

    1990-03-08

    Cancer therapy using chemotherapeutic drugs frequently involves injection of the drug into the body through some intravenous mode of administration, viz, continuous (drip) infusion or single/multiple bolus injection(s). An understanding of the effect of the various modes of administration upon tumor penetration of drug is essential to rational design of drug therapy. This paper investigates drug penetration into a model tumor of slab geometry (between two capillaries) in which the overall transport rate of drug is limited by intra-tumor transport characterized by an effective diffusion coefficient. Employing the method of Finite Fourier Transforms (FFT), analytical solutions have been obtained for transient drug distribution in both the plasma and the tumor following three modes of administration, viz, continuous infusion, single bolus injection and equally-spaced equal-dose multiple bolus injections, of a given amount of drug. The qualitative trends exhibited by the plasma drug distribution profiles are consistent with reported experimental studies. Two concepts, viz, the dimensionless decay constant and the plasma/tumor drug concentration trajectories, are found to be particularly useful in the rational design of drug therapy. The dimensionless decay constant provides a measure of the rate of drug decay in the plasma relative to the rate of drug diffusion into the tumor and is thus characteristic of the tumor/drug system. The magnitude of this parameter dictates the choice of drug administration mode for minimizing drug decay in the plasma while simultaneously maximizing drug transport into the tumor. The concentration trajectories provide a measure of the plasma drug concentration relative to the tumor drug concentration at various times following injection. When the tumor drug concentration exceeds the plasma drug concentration, the drug will begin to diffuse out of the tumor. Knowledge of the time at which this diffusion reversal occurs is especially useful

  2. 76 FR 23324 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-26

    ... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm... Cardiovascular Risk in Diabetes-Lipid (ACCORD Lipid) trial as they relate to the efficacy and safety of the... cholesterol goal. The ACCORD Lipid study was a randomized, double-blind, placebo- controlled add-on trial...

  3. 78 FR 70275 - United States Travel and Tourism Advisory Board

    Science.gov (United States)

    2013-11-25

    ... DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism... an opportunity to apply for membership on the United States Travel and Tourism Advisory Board... Travel and Tourism Advisory Board (Board). The purpose of the Board is to advise the Secretary of...

  4. 77 FR 65693 - Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-10-30

    ...] Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. This meeting was... announced that a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee would be held on...

  5. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

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

    Science.gov (United States)

    2011-01-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

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

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] 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...

  8. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  9. Expand classical drug administration ways by emerging routes using dendrimer drug delivery systems: a concise overview.

    Science.gov (United States)

    Mignani, Serge; El Kazzouli, Saïd; Bousmina, Mosto; Majoral, Jean-Pierre

    2013-10-01

    Drugs are introduced into the body by numerous routes such as enteral (oral, sublingual and rectum administration), parenteral (intravascular, intramuscular, subcutaneous and inhalation administration), or topical (skin and mucosal membranes). Each route has specific purposes, advantages and disadvantages. Today, the oral route remains the preferred one for different reasons such as ease and compliance by patients. Several nanoformulated drugs have been already approved by the FDA, such as Abelcet®, Doxil®, Abraxane® or Vivagel®(Starpharma) which is an anionic G4-poly(L-lysine)-type dendrimer showing potent topical vaginal microbicide activity. Numerous biochemical studies, as well as biological and pharmacological applications of both dendrimer based products (dendrimers as therapeutic compounds per se, like Vivagel®) and dendrimers as drug carriers (covalent conjugation or noncovalent encapsulation of drugs) were described. It is widely known that due to their outstanding physical and chemical properties, dendrimers afforded improvement of corresponding carried-drugs as dendrimer-drug complexes or conjugates (versus plain drug) such as biodistribution and pharmacokinetic behaviors. The purpose of this manuscript is to review the recent progresses of dendrimers as nanoscale drug delivery systems for the delivery of drugs using enteral, parenteral and topical routes. In particular, we focus our attention on the emerging and promising routes such as oral, transdermal, ocular and transmucosal routes using dendrimers as delivery systems. Copyright © 2013 Elsevier B.V. All rights reserved.

  10. 76 FR 67715 - Science Advisory Board

    Science.gov (United States)

    2011-11-02

    ... Administration (NOAA) science programs are of the highest quality and provide optimal support to resource... Advisory Board in Reviewing NOAA's Research and Development Portfolio-Presentation and Discussion; (6) NOAA...

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

    Science.gov (United States)

    2013-02-13

    ... AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110...

  12. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

  13. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...

  14. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  15. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

  16. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  17. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

  18. Estimating preferences for modes of drug administration: The case of US healthcare professionals.

    Science.gov (United States)

    Tetteh, Ebenezer K; Morris, Steve; Titchener-Hooker, Nigel

    2018-01-01

    There are hidden drug administration costs that arise from a mismatch between end-user preferences and how manufacturers choose to formulate their drug products for delivery to patients. The corollary of this is: there are "intangible benefits" from considering end-user preferences in manufacturing patient-friendly medicines. It is important then to have some idea of what pharmaceutical manufacturers should consider in making patient-friendly medicines and of the magnitude of the indirect benefits from doing so. This study aimed to evaluate preferences of healthcare professionals in the US for the non-monetary attributes of different modes of drug administration. It uses these preference orderings to compute a monetary valuation of the indirect benefits from making patient-friendly medicines. A survey collected choice preferences of a sample of 210 healthcare professionals in the US for two unlabelled drug options. These drugs were identical except in the levels of attributes of drug administration. Using the choice data collected, statistical models were estimated to compute gross welfare benefits, measured by the expected compensating variation, from making drugs in a more patient-friendly manner. The monetary value of end-user benefits from developing patient-friendly drug delivery systems is: (1) as large as the annual acquisition costs per full treatment episode for some biologic drugs; and (2) likely to fall in the "high end" of the distribution of the direct monetary costs of drug administration. An examination of end-user preferences should help manufacturers make more effective and efficient use of limited resources for innovations in drug delivery system, or manufacturing research in general. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

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

  20. Adverse Drug Event Monitoring at the Food and Drug Administration: Your Report Can Make a Difference

    OpenAIRE

    Ahmad, Syed Rizwanuddin

    2003-01-01

    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treati...

  1. FDA approves efavirenz. Food and Drug Administration.

    Science.gov (United States)

    Highleyman, L

    1998-10-01

    The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

  2. Comparison of a drug versus money and drug versus drug self-administration choice procedure with oxycodone and morphine in opioid addicts.

    Science.gov (United States)

    Comer, Sandra D; Metz, Verena E; Cooper, Ziva D; Kowalczyk, William J; Jones, Jermaine D; Sullivan, Maria A; Manubay, Jeanne M; Vosburg, Suzanne K; Smith, Mary E; Peyser, Deena; Saccone, Phillip A

    2013-09-01

    This double-blind, placebo-controlled study investigated the effects of oral morphine (0, 45, 135 mg/70 kg) and oral oxycodone (0, 15, 45 mg/70 kg) on buprenorphine-maintained opioid addicts. As a 3: 1 morphine : oxycodone oral dose ratio yielded equivalent subjective and physiological effects in nondependent individuals, this ratio was used in the present study. Two self-administration laboratory procedures - that is, a drug versus money and a drug versus drug procedure - were assessed. Study participants (N=12) lived in the hospital and were maintained on 4 mg/day sublingual buprenorphine. When participants chose between drug and money, money was preferred over all drug doses; only high-dose oxycodone was self-administered more than placebo. When participants chose between drug and drug, both drugs were chosen more than placebo, high doses of each drug were chosen over low doses, and high-dose oxycodone was preferred over high-dose morphine. The subjective, performance-impairing, and miotic effects of high-dose oxycodone were generally greater than those of high-dose morphine. The study demonstrated that a 3: 1 oral dose ratio of morphine : oxycodone was not equipotent in buprenorphine-dependent individuals. Both self-administration procedures were effective for assessing the relative reinforcing effects of drugs; preference for one procedure should be driven by the specific research question of interest.

  3. 75 FR 70215 - Environmental Technologies Trade Advisory Committee (ETTAC), Request for Nominations

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade...: Notice of solicitation of nominations for membership on the Environmental Technologies Trade Advisory Committee (ETTAC). SUMMARY: The Environmental Technologies Trade Advisory Committee (ETTAC) was established...

  4. 75 FR 59227 - U.S. Travel and Tourism Advisory Board

    Science.gov (United States)

    2010-09-27

    ... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board... To Apply for Membership on the U.S. Travel and Tourism Advisory Board. SUMMARY: The Department of Commerce is currently seeking applications to fill three vacant positions on the U.S. Travel and Tourism...

  5. 75 FR 39974 - NASA Advisory Council; Space Operations Committee; Meeting

    Science.gov (United States)

    2010-07-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-074)] NASA Advisory Council; Space... Committee of the NASA Advisory Council. DATES: Wednesday, July 28, 2010, 2-5 p.m. EDT. ADDRESSES: Doubletree..., Washington, DC 20546, 202/358-1507, [email protected]nasa.gov . SUPPLEMENTARY INFORMATION: The agenda for the...

  6. 75 FR 17437 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2010-04-06

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-039)] NASA Advisory Council; Commercial... Committee of the NASA Advisory Council. DATES: Monday, April 26, 2010, 1:30 p.m.-6 p.m. CDT. ADDRESSES: NASA Johnson Space Center, Gilruth Conference Center, 2101 NASA Parkway, Houston, TX 77058. FOR FURTHER...

  7. 75 FR 57102 - Occupational Information Development Advisory Panel Meeting; Correction

    Science.gov (United States)

    2010-09-17

    ... SOCIAL SECURITY ADMINISTRATION [Docket No. SSA-2010-0058] Occupational Information Development Advisory Panel Meeting; Correction AGENCY: Social Security Administration. ACTION: Notice; correction. SUMMARY: The Social Security Administration published a document in the Federal Register of September 13...

  8. Enhancing topical analgesic administration: review and prospect for transdermal and transbuccal drug delivery systems.

    Science.gov (United States)

    Sanz, Roser; Calpena, Ana C; Mallandrich, Mireia; Clares, Beatriz

    2015-01-01

    Topical administration is an appealing method for drug delivery due to its non-invasiveness, self-controlled application, avoidance of first-pass metabolism in the liver and reduction of systemic side effects compared to other conventional routes such as oral and parenteral. However, topical administration must overcome the permeable barriers that skin and mucosa represent for the drug to achieve its desired therapeutic effect. Penetration of drugs through human skin is mainly impaired by the stratum corneum- the uppermost keratinized skin layer. In contrast, the stratified squamous epithelium (a nonkeratinized tissue) represents the major physical barrier for transbuccal drug administration in humans. Different technologies have been studied to enhance the bioavailability or local effects of drugs administered through skin and buccal mucosa. Those technologies involve the use of physical or chemical enhancers and new dosage forms such as vesicles, cyclodextrins, nanoparticles and other complex systems. Combinations of these technologies may further increase drug delivery in some cases. As analgesia is one of the main therapeutic effects sought through topical administration, this paper focuses on the review of drug delivery systems to improve the topical and transdermal/transbuccal drug delivery of substances with known analgesic action. A discussion of their possibilities and limitations is also included.

  9. 77 FR 39705 - National Advisory Council for Environmental Policy and Technology

    Science.gov (United States)

    2012-07-05

    ... and Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Advisory Committee... meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology, and management...

  10. 77 FR 1931 - National Advisory Council for Environmental Policy and Technology

    Science.gov (United States)

    2012-01-12

    ... and Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Advisory Committee... meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology, and management...

  11. 77 FR 3475 - National Advisory Council for Environmental Policy and Technology

    Science.gov (United States)

    2012-01-24

    ... and Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of advisory committee... teleconference of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology, and management...

  12. 76 FR 60535 - Federal Advisory Council on Occupational Safety and Health

    Science.gov (United States)

    2011-09-29

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA--2011-0116] Federal Advisory Council on Occupational Safety and Health AGENCY: Occupational Safety and Health... the Federal Advisory Council on Occupational Safety and Health (FACOSH) until October 31, 2011. DATES...

  13. Frequency and determinants of drug administration errors in the intensive care unit

    NARCIS (Netherlands)

    van den Bemt, PMLA; Fijn, R; van der Voort, PHJ; Gossen, AA; Egberts, TCG; Brouwers, JRBJ

    Objective., The study aimed to identify both the frequency and the determinants of drug administration errors in the intensive care unit. Design: Administration errors were detected by using the disguised-observation technique (observation of medication administrations by nurses, without revealing

  14. 77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

    Science.gov (United States)

    2012-02-01

    ...] Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to the... entitled ``Food and Drug Administration Transparency Initiative: Exploratory Program to [[Page 5028

  15. 77 FR 71474 - Commercial Space Transportation Advisory Committee-Charter Renewal

    Science.gov (United States)

    2012-11-30

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Transportation (DOT). ACTION: Announcement of Charter Renewal of the Commercial Space Transportation Advisory... Administrator of the Federal Aviation Administration (FAA) on the critical matters facing the U.S. commercial...

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

    Science.gov (United States)

    2013-10-23

    ... treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure...

  17. 1 Impact of praziquantel mass drug administration campaign on ...

    African Journals Online (AJOL)

    used to collect information on MDA uptake, knowledge of schistosomiasis, sources .... transmission and in which Praziquantel mass drug administration has been ..... MoHSW (2012) Tanzania Mainland Strategic Master Plan for the Neglected ...

  18. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Science.gov (United States)

    2011-09-09

    ...] Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug... conference for representatives of Health Professional Organizations. Dr. Margaret Hamburg, Commissioner of... person attending, the name of the organization, address, and telephone number. There is no registration...

  19. Pharmaceutical assistance in the enteral administration of drugs: choosing the appropriate pharmaceutical formulation

    Directory of Open Access Journals (Sweden)

    Gisele de Lima

    2009-03-01

    Full Text Available Objective: To study solid medications for oral delivery on the formulary of Hospital Israelita Albert Einstein (HIAE, investigating the  possibility of using these drugs through enteral feeding tubes, and recommending appropriate administration. Methods: Study carried out through survey of solid medications for oral delivery included on the formulary of HIAE, literature review, and analysis of medication monographs, manufacturer information and pharmacotechnical data of active ingredients and excipients. It was observed the factors that might hinder or complicate the administration of these drugs though enteral tubes, and was drawn an information chart with recommendations about drug administration in this context. Rresults: The study evaluated 234 medications; and the main problems of administering these drugs through enteral feeding tubes were as follows: changes in drug pharmacokinetics (38; gastrointestinal damage (9; risk of obstruction (40, drug-nutrient interactions (7; biological hazards (5 and no information (33. Cconclusions: Compiling this information helps the healthcare team to choose the appropriate pharmaceutical formulation for medications administered through enteral tubes, and may help identify adverse events related to this technique.

  20. 78 FR 47714 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

    Science.gov (United States)

    2013-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell...

  1. 78 FR 23571 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

    Science.gov (United States)

    2013-04-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell...

  2. 75 FR 14175 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

    Science.gov (United States)

    2010-03-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell...

  3. 77 FR 22791 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

    Science.gov (United States)

    2012-04-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell...

  4. 76 FR 62814 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

    Science.gov (United States)

    2011-10-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell...

  5. 77 FR 75148 - Request for Applications for United States Travel and Tourism Advisory Board

    Science.gov (United States)

    2012-12-19

    ... States Travel and Tourism Advisory Board AGENCY: International Trade Administration, Commerce. ACTION: Notice of an opportunity to apply for membership on the United States Travel and Tourism Advisory Board... States Travel and Tourism Advisory Board (Board). The purpose of the Board is to advise the Secretary of...

  6. Investigation of the mechanisms of action behind Electromotive Drug Administration (EMDA)

    DEFF Research Database (Denmark)

    Kos, Bor; Vasquez, Juan Luis; Miklavčič, D

    2016-01-01

    Objective. Bladder cancer is a cause of considerable morbidity worldwide. Electromotive Drug Administration is a method that combines intravesical chemotherapy with local electric field application. Electroporation has been suggested among other mechanisms as having a possible role in the therapy......, so the goal of the present study was to investigate the electric fields present in the bladder wall during the treatment to determine which mechanisms might be involved. Material and Methods. Electromotive Drug Administration involves applying intravesical mitomycin C with direct current of 20 m...

  7. 75 FR 53349 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2010-08-31

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-098)] NASA Advisory Council; Commercial... Committee of the NASA Advisory Council. DATES: Tuesday September 14, 8 a.m. to 12 noon CDT. ADDRESSES: NASA..., Washington, DC 20546. Phone 202- 358-1686, fax: 202-358-3878, [email protected]nasa.gov . SUPPLEMENTARY...

  8. 75 FR 5630 - NASA Advisory Council; Space Operations Committee; Meeting

    Science.gov (United States)

    2010-02-03

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-017)] NASA Advisory Council; Space... Committee of the NASA Advisory Council. DATES: Wednesday, February 17, 2010, 9 a.m.-12 p.m. EST. ADDRESSES: NASA Headquarters, 300 E Street, SW., Washington, DC 20456, Room 2U22. FOR FURTHER INFORMATION CONTACT...

  9. 75 FR 39973 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2010-07-13

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-076)] NASA Advisory Council; Commercial... Committee to the NASA Advisory Council. DATES: Thursday, July 29, 2010, 9 a.m.-12 p.m., Eastern. ADDRESSES: NASA Headquarters, 300 E Street, SW., PRC/Room 9H40, Washington, DC 20546. FOR FURTHER INFORMATION...

  10. 76 FR 3674 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2011-01-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-006)] NASA Advisory Council; Commercial... Committee to the NASA Advisory Council. DATES: Tuesday, February 8, 2011, 2 p.m.-3:30 p.m., Local Time. ADDRESSES: NASA Headquarters, 300 E Street, SW., Glennan Conference Center, Room 1Q39, Washington, DC 20546...

  11. 77 FR 41203 - NASA International Space Station Advisory Committee; Meeting

    Science.gov (United States)

    2012-07-12

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-057] NASA International Space Station Advisory Committee; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of..., the National Aeronautics and Space Administration announces an open meeting of the NASA International...

  12. 78 FR 77502 - NASA International Space Station Advisory Committee; Meeting

    Science.gov (United States)

    2013-12-23

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (13-154)] NASA International Space Station Advisory Committee; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of..., the National Aeronautics and Space Administration announces a meeting of the NASA International Space...

  13. 77 FR 2765 - NASA International Space Station Advisory Committee; Meeting

    Science.gov (United States)

    2012-01-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-003)] NASA International Space Station Advisory Committee; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of..., the National Aeronautics and Space Administration announces an open meeting of the NASA International...

  14. 77 FR 66082 - NASA International Space Station Advisory Committee; Meeting

    Science.gov (United States)

    2012-11-01

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-090] NASA International Space Station Advisory Committee; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of..., the National Aeronautics and Space Administration announces an open meeting of the NASA International...

  15. 78 FR 48789 - Veterans' Advisory Committee on Education, Notice of Meeting

    Science.gov (United States)

    2013-08-09

    ... DEPARTMENT OF VETERANS AFFAIRS Veterans' Advisory Committee on Education, Notice of Meeting The..., that the Veterans' Advisory Committee on Education will meet on August 13-14, 2013, in the First Floor... on the administration of education and training programs for Veterans, Servicepersons, Reservists...

  16. 76 FR 35481 - NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting

    Science.gov (United States)

    2011-06-17

    ... Update. --Research and Analysis Update. --Wide-Field Infrared Survey Telescope Science Definition Team... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 11-054] NASA Advisory Council; Science... Subcommittee of the NASA Advisory Council (NAC). This subcommittee reports to the Science Committee of the NAC...

  17. 76 FR 59172 - NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting

    Science.gov (United States)

    2011-09-23

    ... Space Telescope, Science Definition Team. --Physics of the Cosmos/Cosmic Origins/Exoplanet Program... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-083)] NASA Advisory Council; Science... Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC...

  18. Right Whale Sightings Advisory System (RWSAS)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Right Whale Sighting Advisory System (RWSAS) is a NOAA Fisheries program which was designed to reduce collisions between ships and the critically endangered...

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

    Science.gov (United States)

    1995-01-06

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

  20. Assessment of knowledge of pediatric nurses related with drug administration and preparation.

    Science.gov (United States)

    Bülbül, Ali; Kunt, Ayşe; Selalmaz, Melek; Sözeri, Şehrinaz; Uslu, Sinan; Nuhoğlu, Asiye

    2014-12-01

    Aim of this study is to determine the levels of knowledge related with drug administration and drug administration errors of nurses who care for pediatric patients. The study data were obtained from the nurses who were working in the departments of pediatrics in two education and research hospitals in the province of İstanbul and who accepted to participate in the study. The questionnaire form of the study was established by the investigators in accordance with the experiences and literature information. A total of 31 questions related with drug preparation, calculation and administration together with the general working properties of the individual were filled out by face to face interview. The data were evaluated using percent and chi-square tests. The study was initiated after ethics committee approval was obtained from Şişli Hamidiye Etfal Education and Research Hospital (365/2013). The study was conducted with 98 nurses who accepted the questionnaire. The education levels of the participants were as follows: undergraduate (48%), high school (32.7%), associate degree (12.2%), master's degree (6.1%) and postgraduate (1%). It was found that 88.8% of the participants worked in a patient-centered fashion and 11.2% worked in a work-centered fashion. The frequency of interruption/distraction during preparation of treatment was found to be 92.9%. It was found that the frequency of checking by two people during preparation or administration of high risk drugs was 64.3% and the conditions under which drugs should be kept were found to known correctly with a rate of 76.5%. It was found that undergraduate healthcare workers were more successful in converting units (p= 0.000). It was found that powder weight of drugs was considered with a rate of 85.7% in calculation. Conclusively, it was found that nurses who worked in pediatric wards did not receive a standard education in terms of drug administration and preparation. It was found that undergraduate nurses were more

  1. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  2. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  3. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  4. Model-based drug administration : current status of target-controlled infusion and closed-loop control

    NARCIS (Netherlands)

    Kuizenga, Merel H.; Vereecke, Hugo E. M.; Struys, Michel M. R. F.

    Purpose of review Drug administration might be optimized by incorporating pharmacokinetic-dynamic (PK/PD) principles and control engineering theories. This review gives an update of the actual status of target-controlled infusion (TCI) and closed-loop computer-controlled drug administration and the

  5. 75 FR 72792 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2010-11-26

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of open meeting by teleconference. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee...

  6. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

  7. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

  8. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

  9. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  10. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  11. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  12. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

  13. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

  14. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  15. ALTERNATIVE ROUTES OF DRUG ADMINISTRATION: ADVANTAGES AND DISADVANTAGES (SUBJECT REVIEW OF AMERICAN ACADEMY OF PEDIATRICS

    Directory of Open Access Journals (Sweden)

    article editorial

    2006-01-01

    Full Text Available During the past 20 years advances in drug formulations and innovative routes of administration have been made. Our understanding of drug transport across tissues has increased. These changes have often resulted in improved patient adherence to the therapeutic regiment and pharmacologic response. The administration of drugs by transdermal or transmucosal routes offers the advantage of being relatively painless. Also, the potential for greater flexibility in a variety of clinical situations exists, often precluding the need to establish intravinus access which is a particular benefit for children. This statement focuses on the advantages and disadvantages of alternative routes of drug administration. Issues of particular importance in the care of pediatric patients especially factors that could lead to drug-relaxed toxicity or adverse responses are emphasized.Key words: drug formulation, pharmacoKINETICS, pharmacodynamics, drug, children.

  16. Evaluation of radiation doses from radioactive drugs

    International Nuclear Information System (INIS)

    Halperin, J.A.; Grove, G.R.

    1977-01-01

    Radioactive new drugs are regulated by the Food and Drug Administration (FDA) in the United States. Before a new drug can be marketed it must have an approved New Drug Application (NDA). Clinical investigations of a radioactive new drug are carried out under a Notice of Claimed Investigational Exemption for a New Drug (IND), submitted to the FDA. In the review of the IND, radiation doses are projected on the basis of experimental data from animal models and from calculations based upon radiation characteristics, predicted biodistribution of the drug in humans, and activity to be administered. FDA physicians review anticipated doses and prevent clinical investigations in humans when the potential risk of the use of a radioactive substance outweighs the prospect of achieving beneficial results from the administration of the drug. In the evaluation of an NDA, FDA staff attempt to assure that the intended diagnostic or therapeutic effect is achievable with the lowest practicable radiation dose. Radiation doses from radioactive new drugs are evaluated by physicians within the FDA. Important radioactive new drugs are also evaluated by the Radiopharmaceuticals Advisory Committee. FDA also supports the Center for Internal Radiation Dosimetry at Oak Ridge, to provide information regarding in vivo distribution and dosimetry to critical organs and the whole body from radioactive new drugs. The process for evaluation of radiation doses from radioactive new drugs for protection against use of unnecessary radiation exposure by patients in nuclear medicine procedures, a

  17. 76 FR 32374 - National Advisory Committee on Occupational Safety and Health (NACOSH)

    Science.gov (United States)

    2011-06-06

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0065] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and NACOSH subgroups. SUMMARY: The National Advisory...

  18. 75 FR 28659 - National Advisory Committee on Occupational Safety and Health (NACOSH)

    Science.gov (United States)

    2010-05-21

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH). SUMMARY: The National Advisory Committee on Occupational...

  19. 76 FR 77776 - Environmental Technologies Trade Advisory Committee Public Meeting

    Science.gov (United States)

    2011-12-14

    ... DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade... meeting of the Environmental Technologies Trade Advisory Committee (ETTAC). DATES: The meeting is... Energy & Environmental Industries (OEEI), International Trade Administration, Room 4053, 1401...

  20. 76 FR 51001 - Environmental Technologies Trade Advisory Committee Public Meeting

    Science.gov (United States)

    2011-08-17

    ... DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade... meeting of the Environmental Technologies Trade Advisory Committee (ETTAC). DATES: The meeting is... Energy & Environmental Industries (OEEI), International Trade Administration, Room 4053, 1401...

  1. 77 FR 58356 - Environmental Technologies Trade Advisory Committee Public Meeting

    Science.gov (United States)

    2012-09-20

    ... DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade... meeting of the Environmental Technologies Trade Advisory Committee (ETTAC). DATES: The meeting is... Energy & Environmental Industries (OEEI), International Trade Administration, Room 4053, 1401...

  2. 78 FR 4834 - Environmental Technologies Trade Advisory Committee Public Meeting

    Science.gov (United States)

    2013-01-23

    ... DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade... meeting of the Environmental Technologies Trade Advisory Committee (ETTAC). DATES: The meeting is... Energy & Environmental Industries (OEEI), International Trade Administration, Room 4053, 1401...

  3. 75 FR 38779 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2010-07-06

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides...

  4. 75 FR 7234 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2010-02-18

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of Open Meeting. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides...

  5. 75 FR 64699 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2010-10-20

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides...

  6. 75 FR 21602 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2010-04-26

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides...

  7. 75 FR 75968 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2010-12-07

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides...

  8. 77 FR 25145 - Commerce Spectrum Management Advisory Committee Meeting

    Science.gov (United States)

    2012-04-27

    ... DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Commerce... Administration, U.S. Department of Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides...

  9. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  10. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  11. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  12. 77 FR 2719 - National Advisory Council for Environmental Policy and Technology; Meeting

    Science.gov (United States)

    2012-01-19

    ... and Technology; Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Advisory... a public meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology...

  13. 75 FR 48411 - Research, Engineering and Development Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-10

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development.... 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development (R, E&D) Advisory Committee. Name: Research, Engineering & Development Advisory Committee. Time and Date: September...

  14. 77 FR 46126 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

    Science.gov (United States)

    2012-08-02

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0003] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and... Advisory Committee for Occupational Safety and Health. SUMMARY: OSHA invites interested persons to submit...

  15. 76 FR 73689 - National Advisory Committee on Occupational Safety and Health (NACOSH)

    Science.gov (United States)

    2011-11-29

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0065] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and NACOSH Work Groups. SUMMARY: The National Advisory...

  16. 76 FR 15057 - Notice of Proposed Exemption; BlackRock, Inc. and Its Investment Advisory, Investment Management...

    Science.gov (United States)

    2011-03-18

    ... Administration Notice of Proposed Exemption; BlackRock, Inc. and Its Investment Advisory, Investment Management...; BlackRock, Inc. and Its Investment Advisory, Investment Management and Broker-Dealer Affiliates and... its investment advisory, investment management and broker-dealer affiliates and their successors. The...

  17. 75 FR 61778 - NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting

    Science.gov (United States)

    2010-10-06

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-118)] NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting AGENCY: National Aeronautics and Space Administration. ACTION... amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics...

  18. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  19. Drug distribution in man: a positron emission tomography study after oral administration of the labelled neuroprotective drug vinpocetine

    International Nuclear Information System (INIS)

    Gulyas, Balazs; Halldin, Christer; Sandell, Johan; Farde, Lars; Sovago, Judit; Cselenyi, Zsolt; Vas, Adam; Kiss, Bela; Karpati, Egon

    2002-01-01

    Direct information on the distribution of a drug requires measurements in various tissues. Such data have until now been obtained in animals, or have indirectly been calculated from plasma measurements in humans using mathematical models. Here we suggest the use of positron emission tomography (PET) as a method to obtain direct measurements of drug distribution in the human body. The distribution in body and brain of vinpocetine, a neuroprotective drug widely used in the prevention and treatment of cerebrovascular diseases, was followed after oral administration. Vinpocetine was labelled with carbon-11 and radioactivity was measured by PET in stomach, liver, brain and kidney in six healthy volunteers. The radioactivity in blood and urine as well as the fractions of [ 11 C]vinpocetine and labelled metabolites in plasma were also determined. After oral administration, [ 11 C]vinpocetine appeared immediately in the stomach and within minutes in the liver and the blood. In the blood the level of radioactivity continuously increased until the end of the measurement period, whereas the fraction of the unchanged mother compound decreased. Radioactivity uptake and distribution in the brain were demonstrable from the tenth minute after the administration of the labelled drug. Brain distribution was heterogeneous, similar to the distribution previously reported after intravenous administration. These findings indicate that vinpocetine, administered orally in humans, readily enters the bloodstream from the stomach and gastrointestinal tract and, consequently, passes the blood-brain barrier and enters the brain. Radioactivity from [ 11 C]vinpocetine was also demonstrated in the kidneys and in urine, indicating that at least a part of the radioactive drug and labelled metabolites is eliminated from the body through the kidneys. This study is the first to demonstrate that PET might be a useful, direct and non-invasive tool to study the distribution and pharmacokinetics of orally

  20. Drug distribution in man: a positron emission tomography study after oral administration of the labelled neuroprotective drug vinpocetine.

    Science.gov (United States)

    Gulyás, Balázs; Halldin, Christer; Sóvágó, Judit; Sandell, Johan; Cselényi, Zsolt; Vas, Adám; Kiss, Béla; Kárpáti, Egon; Farde, Lars

    2002-08-01

    Direct information on the distribution of a drug requires measurements in various tissues. Such data have until now been obtained in animals, or have indirectly been calculated from plasma measurements in humans using mathematical models. Here we suggest the use of positron emission tomography (PET) as a method to obtain direct measurements of drug distribution in the human body. The distribution in body and brain of vinpocetine, a neuroprotective drug widely used in the prevention and treatment of cerebrovascular diseases, was followed after oral administration. Vinpocetine was labelled with carbon-11 and radioactivity was measured by PET in stomach, liver, brain and kidney in six healthy volunteers. The radioactivity in blood and urine as well as the fractions of [(11)C]vinpocetine and labelled metabolites in plasma were also determined. After oral administration, [(11)C]vinpocetine appeared immediately in the stomach and within minutes in the liver and the blood. In the blood the level of radioactivity continuously increased until the end of the measurement period, whereas the fraction of the unchanged mother compound decreased. Radioactivity uptake and distribution in the brain were demonstrable from the tenth minute after the administration of the labelled drug. Brain distribution was heterogeneous, similar to the distribution previously reported after intravenous administration. These findings indicate that vinpocetine, administered orally in humans, readily enters the bloodstream from the stomach and gastrointestinal tract and, consequently, passes the blood-brain barrier and enters the brain. Radioactivity from [(11)C]vinpocetine was also demonstrated in the kidneys and in urine, indicating that at least a part of the radioactive drug and labelled metabolites is eliminated from the body through the kidneys. This study is the first to demonstrate that PET might be a useful, direct and non-invasive tool to study the distribution and pharmacokinetics of orally