|
|
|
CDER 2003 Meeting Documents
|
|
Anesthetic
& Life Support Drugs Advisory Committee
Executive Secretary: Johanna M Clifford, MS,
RN, BSN (HFD-21) (301) 827-7001
November 18-19, 2003
September 9-10, 2003
Top
Executive Secretary: Tara P. Turner, Pharm.D. (HFD-21),
(301) 827-7001
October 29-30, 2003 Pediatric Subcommittee
Top
-
- October 28, 2003 Final
Agenda (PDF) (Word)
- October 28, 2003
Committee Roster (PDF)
(Word)
- October
28, 2003 Additional Participants (PDF)
(Word)
- October 28, 2003 Questions
(PDF) (Word)
- October 28, 2003 Briefing Information
- October 28, 2003 Slides
- October 28, 2003 Transcript
(PDF) (Word)
- October 29, 2003 Final
Agenda (PDF) (Word)
- October 29, 2003
Committee Roster (PDF)
(Word)
- October
29, 2003 Additional Participants (PDF)
(Word)
- October 29, 2003 Questions
(PDF) (Word)
- October 29, 2003 Briefing Information
- October 29, 2003 Slides
- October 29, 2003 Transcript
(PDF) (Word)
Top
June 11-12, 2003 Pediatric Subcommittee
March 4-6, 2003
- Notice
of Meeting (PDF)
- March 4, 2003 Agenda (PDF)
(Word)
- March 4, 2003
Committee Members Roster (PDF)
(Word)
- March
4, 2003 Consultants/Guests Roster (PDF)
(Word)
- March 4, 2003 Questions
(PDF) (Word)
- March 4, 2003 Briefing Information
- March 4, 2003 Slides
- March 4, 2003 Transcript
(PDF) (Word)
- March 5, 2003 Agenda (PDF)
(Word)
- March 5, 2003
Committee Members Roster (PDF)
(Word)
- March
5, 2003 Consultants/Guests (PDF)
(Word)
- March 5, 2003 Briefing Information
- March 5, 2003 Slides
- March 5, 2003 Transcript
(PDF) (Word)
March 3, 2003 Pediatric Subcommittee
- Notice
of Meeting (PDF)
- March 3, 2003 Final Agenda
(PDF) (Word)
- March 3, 2003 Draft Agenda
(PDF) (Word)
- March 3, 2003 Final Questions
(PDF) (Word)
- March 3, 2003 Draft
Questions (PDF)
(Word)
- March 3, 2003
Committee Roster (PDF)
(Word)
- March
3, 2003 Consultants/Guests Roster (PDF)
(Word)
- March 3, 2003 Briefing Information
- March 3, 2003 Slides
- March 3, 2003 Transcript
(PDF) (Word)
- March 3, 2003 Minutes
(PDF) (Word)
Top
January 8-9, 2003
- Notice
of Meeting (PDF)
- January 8, 2003 Draft
Agenda (PDF) (Word)
- January 8, 2003 Final
Agenda (PDF) (Word)
- January 8, 2003
Committee Roster (PDF)
(Word)
- January
8, 2003 Consultants/Guests Roster (PDF)
(Word)
- January 8, 2003 Questions
(PDF) (Word)
- January
8, 2003 Briefing Information
- January 8, 2003 Erratum (PDF)
- January 8, 2003 Slides
- January 8, 2003 Transcript
(PDF) (Word)
- January 9, 2003 Final
Agenda (PDF) (Word)
- January 9, 2003
Committee Roster (PDF)
- January
9, 2003 Consultants-Guests Roster (PDF)
(Word)
- January 9, 2003 Questions
(PDF) (Word)
- January
9, 2003 Background Information
- January 9, 2003 Slides
- January 9, 2003 Transcript
(PDF) (Word)
Top
Antiviral
Drugs Advisory Committee
Executive Secretary: Tara P. Turner, Pharm.D.
(HFD-21), (301) 827-7001
August 20, 2003
May 13-14, 2003
- Notice
of Meeting (PDF)
- May 13, 2003 Final Agenda
(PDF) (Word)
- May 13, 2003 Draft Agenda
(PDF) (Word)
- May 13, 2003 Committee
Roster (PDF)
(Word)
- May
13, 2003 Additional Participants (PDF)
(Word)
- May 13, 2003 Final
Questions (PDF)
(Word)
- May 13, 2003 Briefing Information
- May 13, 2003 Slides
- May 13, 2003 Transcript
(PDF) (Word)
- May 14, 2003 Final Agenda
(PDF) (Word)
- May 14, 2003 Draft Agenda
(PDF) (Word)
- May 14, 2003 Committee
Roster (PDF)
(Word)
- May
14, 2003 Additional Participants (PDF)
(Word)
- May 14, 2003 Final
Questions (PDF)
(Word)
- May 14, 2003 Briefing Information
- May 14, 2003 Slides
- May 14, 2003 Transcript
(PDF) (Word)
Top
Arthritis
Advisory Committee
Executive Secretary: Kimberly Littleton Topper, MS (HFD-21),
(301) 287-7001
September 29-30, 2003
Top
June 23-24, 2003
March 4-5, 2003
- Notice
of Meeting (PDF)
- March 4, 2003 Agenda (PDF)
(Word)
- March 4, 2003
Committee Members Roster (PDF)
(Word)
- March
4, 2003 Consultants/Guests Roster (PDF)
(Word)
- March 4,
2003 Open Public Hearing Speakers (PDF)
(Word)
- March 4, 2003 Questions
(PDF) (Word)
- March 4, 2003 Briefing Information
- March 4, 2003 Slides
- March 4, 2003 Transcript
(PDF) (Word)
- March 5, 2002 Agenda (PDF)
(Word)
- March 5, 2003
Committee Members Roster (PDF)
(Word)
- March
5, 2003 Consultants/Guests Roster (PDF)
(Word)
- March 5,
2003 Open Public Hearing Speakers (PDF)
(Word)
- March 5, 2003 Questions
(PDF) (Word)
- March 5, 2003 Briefing Information
- March 5, 2003 Slides
- March 5, 2003 Transcript
(PDF) (Word)
Top
Cardiovascular
and Renal Drugs Advisory Committee
Executive Secretary: Dornette Spell-LeSane, NP-C, MHA
(HFD-21), (301) 827-7001
December 8-9, 2003
-
- December 8, 2003 Final
Agenda (PDF) (Word)
- December 8, 2003 Final
Questions (PDF)
(Word)
- December 8, 2003
Committee Roster (PDF)
(Word)
- December 8, 2003 Briefing Information
- December 8, 2003 Slides
- December 9, 2003 Transcript
(PDF) (Word)
- December 9, 2003
Errata (PDF)
(Word)
- December 9, 2003 Final
Agenda (PDF) (Word)
- December 9, 2003 Final
Questions (PDF)
(Word)
- December 9, 2003 Briefing Information
- December 9, 2003 Slides
- December 9, 2003 Transcript
(PDF) (Word)
- December 9, 2003
Errata (PDF)
(Word)
January 6-7, 2003
- Notice
of Meeting (PDF)
- January 6, 2003 Final
Agenda (PDF) (Word)
- January
6, 2003 Questions (PDF)
(Word)
- January
6, 2003 Briefing Information
- January 6, 2003 Slides
- January 6, 2003 Transcript
(PDF) (Word)
- January 6, 2003
Concordance Index (PDF)
- January 7, 2003 Final
Agenda (PDF) (Word)
- January 7, 2003 Questions
(PDF) (Word)
- January 7, 2003 Briefing
Information
- January 7, 2003 Slides
- January 7, 2003 Transcript
(PDF) (Word)
- January 7, 2003
Concordance Index (PDF)
Top
Dermatologic
and Ophthalmic Drugs Advisory Committee
Executive Secretary: Kimberly
Littleton Topper, MS (HFD-21), (301) 827-7001
September 25, 2003
Top
September 9-10, 2003
- Notice
of Meeting (PDF)
- September 9, 2003 Draft
Agenda (PDF) (Word)
- September
9, 2003 Discussion Topics (PDF)
(Word)
- September
9, 2003 Participants Roster (PDF)
(Word)
- September 9, 2003 Briefing
Information
- September 9, 2003 Slides
- September 9, 2003 Transcript
(PDF) (Word)
- September 10, 2003 Draft
Agenda (PDF) (Word)
- September
10, 2003 Participants Roster (PDF)
(Word)
- September 10, 2003 Briefing
Information
- September 10, 2003 Slides
- September 10, 2003 Transcript
(PDF) (Word)
Top
March 17, 2003
Top
Drug
Safety and Risk Management Advisory Committee
Executive Secretary: Shalini Jain, MBA (HFD-21)
(301) 827-7001
December 4, 2003
September 19, 2003 Postponed
Top
September 18, 2003 Postponed
Top
Executive Secretary: Dornette Spell-LeSane, NP-C, MHA
(HFD-21) (301) 827-7001
October 7, 2003
Top
July 9, 2003
January 13-15, 2003
- Notice
of Meeting
(PDF)
- January
13, 2003 Roster
(PDF) (Word)
- January
13, 2003 Consultants and Guests (PDF)
(Word)
- January 13,
2003 Open Public Hearing Speaker (PDF)
(Word)
- January 13, 2003 Draft
Agenda (PDF)
(Word)
- January 13, 2003
Briefing Information
- January
13, 2003 Preliminary Discussion Topics
(PDF)
(Word)
- January
13, 2003 Final Questions to the Committee
(PDF)
(Word)
- January 13, 2003 Slides
- January 13, 2003 Transcript
(PDF) (Word)
- January 14, 2003
Committee Roster (PDF)
(Word)
- January
14, 2003 Consultants and Guest Roster
(PDF)
(Word)
- January 14,
2003 Open Public Hearing Speakers
(PDF)
(Word)
- January
14, 2003 Preliminary Discussion Topics
(PDF)
(Word)
- January
14, 2003 Final Questions (PDF)
(Word)
- January 14, 2003
Briefing Information
- January 14, 2003 Slides
- January 14, 2003 Transcript
(PDF) (Word)
- January 15,
2003 Open Public Hearing Speakers (PDF)
(Word)
- January
15, 2003 Preliminary Discussion Topics
(PDF)
(Word)
- January
15, 2003 Final Questions (PDF)
- January 15, 2003 Briefing
Information
- January
15, 2003 Errata (PDF)
(Word)
- January 15, 2003 Slides
- January 15, 2003 Transcript
(PDF) (Word)
Top
Gastrointestinal
Drugs Advisory Committee
Executive Secretary: Thomas H. Perez, MPH, R.Ph.,
(HFD-21), (301) 827-7001
June 25-26, 2003
- Notice
of Meeting (PDF)
- June 25, 2003 Final Agenda
(PDF) (Word)
- June 25, 2003 Questions
(PDF) (Word)
- June 25, 2003 Briefing Information
- June 25, 2003 Slides
- June 25, 2003 Transcript
(PDF) (Word)
- June 26, 2003 Final Agenda
(PDF) (Word)
- June 26, 2003 Questions
(PDF) (Word)
- June 26, 2003 Briefing Information
- June 26, 2003 Slides
- June 26, 2003 Transcript
(PDF) (Word)
March 6, 2003
Top
Nonprescription
Drugs Advisory Committee
Executive Secretary: Karen M. Templeton-Somers,
PhD (HFD-21), (301) 827-7001
December 16, 2003 Joint meeting with Advisory Committee
for Reproductive Health Drugs
June 12, 2003
Top
Oncologic
Drugs Advisory Committee
Executive Secretary: Johanna M. Clifford, MS,
RN, BSN (HFD-21) (301) 827-7001
December 16, 2003
October 9, 2003 Pediatric Oncology Subcommittee
July 15, 2003 Pediatric Oncology Subcommittee
Top
March 12-13, 2003
March 4, 2003 Pediatric Oncology Subcommittee
Top
Peripheral
and Central Nervous System Drugs Advisory Committee
Executive Secretary: Anuja M. Patel, MPH (HFD-21),
(301) 827-7001
September 24-25, 2003
Top
May 16, 2002 [Cancelled]
Top
Pharmaceutical
Science, Advisory Committee for
Executive Secretary: Hilda F. Scharen (HFD-21)
(301) 827-7001
November 17-18, 2003 Clinical Pharmacology Subcommittee
-
- November 17-18, 2003
Draft Agenda (PDF)
(Word)
- November 17,
18, 2003 Roster (PDF)
(Word)
- November 17-18,
2003 Briefing Information
- November 17-18,
2003 Questions (PDF)
(Word)
- November 17-18,
2003 Bibliography (PDF)
(Word)
- November 17, 2003 Slides
- November 17, 2003 Transcript
(PDF) (Word)
- November 18, 2003 Slides
- November 18, 2003 Transcript
(PDF) (Word)
- November 18, 2003 Summary Minutes
(PDF) (Word)
-
- October 21-22, 2003 Revised
Draft Agenda (PDF)
(Word)
- October 21-22, 2003 Draft
Agenda (PDF) (Word)
- October 21-22, 2003
Committee Roster (PDF)
(Word)
- October 21-22, 2003
Draft Questions (PDF)
(Word)
- October 21-22, 2003 Briefing
Information
- October 21, 2003 Slides
- October 21, 2003 Transcript (PDF)
- October 22, 2003 Slides
- October 22, 2003 Transcript (PDF)
- October 21-22, 2003 Summary
Minutes (PDF) (Word)
September 17-18, 2003 Manufacturing Subcommittee
Top
June 10, 2003 Pharmacology and Toxicology Subcommittee
May 21-22, 2003 Manufacturing Subcommittee
Top
April 22-23, 2003 Clinical Pharmacology Subcommittee
March 21, 2003 Manufacturing Subcommittee [ Cancelled
]
Top
March 12-13, 2003
- Notice
of Meeting (PDF)
- March 12, 2003 Agenda (PDF)
(Word)
- March
12, 2003 Committee Members Roster (PDF)
(Word)
- March 12, 2003
Participants Roster (PDF)
(Word)
- March 12, 2003 Questions
(PDF) (Word)
- March 12, 2003 Briefing Information
- March 12, 2003 Slides
- March 12, 2003 Transcript
(PDF) (Word)
- March 13, 2003 Agenda (PDF)
(Word)
- March 13, 2003 Briefing Information
- March 13, 2003 Slides
- March 13, 2003 Transcript
(PDF) (Word)
Top
Psychopharmacologic
Drugs Advisory Committee
Executive Secretary: Anuja M. Patel, MPH (HFD-21),
(301) 827-7001
June 16, 2003
Top
Pulmonary-Allergy
Drug Advisory Committee
Executive Secretary: Kimberly Littleton Topper,
MS (HFD-21), (301) 827-7001
September 5, 2003
Top
May 15, 2003
Top
Reproductive
Health Drugs, Advisory Committee for
Executive Secretary: Shalini Jain, MBA (HFD-21)
(301) 827-7001
December 16, 2003 Joint meeting with Nonprescription
Drugs Advisory Committee
Page updated:
July 11, 2006
|
|
|
|
|
|
|
|
|
|
|
|