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CDER 2007 Meeting Documents
Anesthetic and Life Support Drugs Advisory Committee
Executive Secretary: Vicky Ferretti-Aceto, Pharm.D., R.Ph., (HFD-21), (301) 827-7001
March 29, 2007
- Notice of Meeting (txt) (pdf)
- There are no Nature and Basis Statements of Conflict(s) of Interest
- Draft Agenda (pdf)
- Revised Committee Roster (pdf)
- Revised Meeting Roster (pdf)
- Roster (pdf)
- Briefing Information (htm)
- Slides (htm)
- Minutes (pdf)
- Transcript (rtf) (pdf), Concordance Index (pdf)
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Anti-Infective Drugs Advisory Committee
Executive Secretary: LT Sohail Mosaddegh, Pharm.D., R.Ph., (HFD-21), (301) 827-7001
April 12, 2007 Joint Meeting with Pediatric Advisory Committee
- Notice of Meeting (txt) (pdf)
- There are no Nature and Basis Statements of Conflict(s) of Interest
- Final Agenda (pdf)
- Draft Agenda (pdf)
- Final Meeting Roster (pdf)
- Anti-Infective Drugs AC Roster (pdf)
- Draft Meeting Roster (pdf)
- Pediatric AC Roster (pdf)
- Briefing Information (htm)
- Final Questions (pdf)
- Draft Questions (pdf)
- Slides (htm)
- Transcript: Part1.pdf, Part 2, pdf, Part 3.pdf, Part 4.pdf
- Minutes (pdf)
April 11, 2007
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Antiviral Drugs Advisory Committee
Executive Secretary: Cicely Reese, Pharm.D., (HFD-21), (301) 827-7001
September 5, 2007
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- No Waivers for Conflicts of Interest
- Final Agenda for September 5, 2007 (pdf)
- Draft Agenda for September 5, 2007 Meeting (pdf)
- Final Meeting Roster for September 5, 2007 (pdf)
- Roster for September 5, 2007 Meetings: Draft Meeting (pdf), Committee (pdf)
- Final Questions for September 5, 2007 Meeting (pdf)
- Draft Questions for September 5, 2007 Meeting (pdf)
- Briefing Information for September 5, 2007 Meeting (htm)
- Slides for September 5, 2007 (htm)
- Transcript: (Part1.pdf), (Part2.pdf), (Part3.pdf)
April 24, 2007
- Notice of Meeting (txt) (pdf)
- Nature and Basis Statements of Conflict(s) of Interest for April 24, 2007 (htm)
- Change in Meeting Location for April 24, 2007 Meeting (pdf)
- Final Agenda (pdf)
- Draft Agenda (pdf)
- Final Roster of Voting Committee Members (pdf)
- Rosters : Committee (pdf), Meeting (pdf)
- Briefing Information (htm)
- Final Report (pdf)
- Final Questions for April 24, 2007 Meeting (pdf) (ppt) (htm)
- Slides (htm)
- Minutes (pdf)
- Transcript (Part1.pdf) (Part2.pdf) (Part3.pdf) (Part4.pdf) (Index.pdf)
Arthritis Drug Advisory Committee
Executive Secretary: Niclole Vesely, Pharm. D., RPL (HFD-21), (301) 827-7001
April 12, 2007
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Cardiovascular & Renal Drugs Advisory Committee
Executive Secretary: Cathy A. Miller, MPH, RN, (HFD-21), (301) 827-7001
December 11 and 12, 2007
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Waivers for Conflicts of Interest for December 11-12, 2007 Meeting (htm)
- Draft Agenda for December 11 & 12, 2007 (pdf)
- Roster for December 11, 2007 (pdf)
- Final Roster for December 11, 2007 (pdf)
- Roster for December 12, 2007 (pdf)
- Final Roster for December 12, 2007 (pdf)
- Briefing Information for December 11, 2007 (htm)
- Briefing Information for December 12, 2007 (htm)
- Questions for December 11, 2007: Part1.pdf, Part2.pdf
- Final Questions for December 11, 2007: Part1Final.pdf, Part2Final.pdf
- Questions for December 12, 2007 (pdf)
- Final Questions for December 12, 2007 (SS)
- Slides for December 11, 2007 (htm)
- Slides for December 12, 2007 (htm)
- Minutes for December 11, 2007 (pdf)
- Minutes for December 12, 2007 (pdf)
- Transcript for December 11, 2007 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
- Transcript for December 12, 2007 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
October 16, 2007
September 12, 2007 Joint Meeting with the Drug Safety and Risk Management Advisory Committee
September 11, 2007 Joint Meeting with the Drug Safety and Risk Management Advisory Committee
April 18, 2007
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Dermatologic and Ophthalmic Drugs Advisory Committee
Executive Secretary: LT Sohail Mosaddeh, Pharm.D., R.Ph., (HFD-21), (301) 827-7001
August 1, 2007 Joint Meeting with the Drug Safety and Risk Management Advisory Committee
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Nature and Basis Statements of Conflict(s) of Interest
(htm)
- Final Agenda (pdf)
- Agenda (pdf)
- Final Meeting Roster (pdf)
- Rosters: Meeting (pdf), DODAC Committee (pdf), DSARM Committee (pdf)
- Briefing Information (htm) (Updated 9/7/07- added Addendum)
- Final Questions (pdf)
- Slides (htm)
- Transcript (Part1.pdf), (Part2.pdf), (Part3.pdf)
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Drug Safety and Risk Management Advisory Committee
Executive Secretary: Vicky Ferretti-Aceto, PharmD, R.Ph. (HFD-21), (301) 827-7001
September 12, 2007 Joint Meeting with the Cardiovascular & Renal Drugs Advisory Committee
September 11, 2007 Joint Meeting with the Cardiovascular & Renal Drugs Advisory Committee
August 1, 2007 Joint Meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee
July 31, 2007 Joint Meeting with the Gastrointestinal Drugs Advisory Committee
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Nature and Basis Statements of Conflict(s) of Interest
(htm)
- Final Agenda (pdf)
- Draft Agenda (pdf)
- Final Rosters: Meeting (pdf), DSARM (pdf), GIDAC (pdf)
- Rosters: Draft Meeting (pdf), DSARM (pdf), GIDAC (pdf)
- Briefing Information (htm) Updated with Addenda (7/27/07)
- Additional Addendum to follow (posted, see above)
- Final Questions (pdf)
- Slides (htm)
- Minutes (pdf)
- Transcript (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4,pdf), (Part5.pdf)
July 30, 2007 Joint Meeting with the Endocrinologic and Metabolic Drugs Advisory Committee
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Endocrinologic and Metabolic Drugs Advisory Committee
Executive Secretary: Cathy A. Miller, MPH, RN, (HFD-21), (301) 827-7001
December 13, 2007 Joint Meeting with the Nonprescription Drugs Advisory Committee
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Waivers for Conflicts of Interest for December 13, 2007 Meeting (htm)
- Agenda (pdf)
- Final Agenda (pdf)
- Rosters: EMDAC Committee (pdf), NDAC Committee (pdf), Meeting (pdf)
- Final Roster (pdf)
- Briefing Information (htm)
- Draft Questions (pdf)
- Final Questions (pdf)
- Slides (htm)
- Final Minutes (pdf)
- Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
July 30, 2007 Joint Meeting with the Drug Safety and Risk Management Advisory Committee
June 13, 2007
- Notice of Meeting (pdf)
(htm)
- No Waivers for Conflicts of Interest
- Draft Agenda (pdf)
- Draft Meeting Roster (pdf)
- Draft Committee Roster (pdf)
- Briefing Information (htm)
- ERRATA to Briefing Information for June 13, 2007 Meeting (pdf)
- Final Questions (ppt) (htm)
- Draft Questions (pdf)
- Slides for June 13, 2007 Meeting (htm)
- Final Minutes (pdf)
- Transcript: (Index.pdf), (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf)
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Gastrointestinal Drugs Advisory Committee
Executive Secretary: Vicky Ferretti-Aceto, PharmD, R.Ph. (HFD-21), (301) 827-7001
July 31, 2007 Joint Meeting with the Drug Safety and Risk Management Advisory Committee
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Nature and Basis Statements of Conflict(s) of Interest
(htm)
- Final Agenda (pdf)
- Draft Agenda (pdf)
- Final Rosters: Meeting (pdf), DSARM (pdf), GIDAC (pdf)
- Rosters: Draft Meeting (pdf), DSARM (pdf), GIDAC (pdf)
- Briefing Information (htm) Updated with Addenda (7/27/07)
- Additional Addendum to follow (posted, see above)
- Final Questions (pdf)
- Slides (htm)
- Minutes (pdf)
- Transcript (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4,pdf), (Part5.pdf)
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Nonprescription Drugs Advisory Committee
Executive Secretary: LT Darrell Lyons, BSN, RN, (HFD-21), (301) 827-7001
December 14, 2007
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Waivers for Conflicts of Interest (htm)
- Agenda (pdf)
- Final Agenda (pdf)
- Rosters: Committee (pdf), Meeting (pdf)
- Final NDAC Members Roster (pdf)
- Briefing Information (htm)
- Draft Questions (pdf)
- Final Questions (pdf)
- Slides (htm)
- Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
- Minutes (pdf)
December 13, 2007 Joint Meeting with the Endocrinologic and Metabolic Drugs Advisory Committee
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Waivers for Conflicts of Interest for December 13, 2007 Meeting (htm)
- Agenda (pdf)
- Final Agenda (pdf)
- Rosters: EMDAC Committee (pdf), NDAC Committee (pdf), Meeting (pdf)
- Final Roster (pdf)
- Briefing Information (htm)
- Draft Questions (pdf)
- Final Questions (pdf)
- Slides (htm)
- Final Minutes (pdf)
- Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
October 18 & 19, 2007 Joint Meeting with the Pediatric Advisory Committee
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Amendment of Notice [TXT] [PDF] [PRE-PUB]
- Updated Waivers for Conflicts of Interest for October 18 & 19, 2007 Meeting (htm)
- Posted Nature and Basis Statements of Conflict(s) of Interest for October 18-19, 2007 Meeting (htm)
- Draft Agenda (pdf)
- Final Agenda (pdf)
- Rosters for October 18 & 19, 2007: Meeting (pdf), Committee (pdf)
- Final Rosters for October 18 & 19, 2007: Meeting (pdf), Committee (pdf)
- Questions: (pdf)
- Briefing Information for October 18 and 19, 2007 Meeting (htm)
- Errata
to FDA Background document for the advisory committee meeting on October 18
& 19, 2007 (pdf) (htm)
- Slides for October 18 & 19, 2007 (htm)
- Final Minutes for October 18 & 19, 2007 (pdf)
- Transcript for October 18 & 19, 2007: (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf)
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Oncologic Drugs Advisory Committee
Executive Secretary: Niclole Vesely, Pharm. D., RPL (HFD-21), (301) 827-7001
December 5, 2007
- Notice of Meeting [TXT] [PDF] [PRE-PUB]
- Waivers for Conflicts of Interest (htm)
- Final Agenda (pdf)
- Members Roster (pdf)
- Committee Roster (pdf)
- Briefing for December 5, 2007 Meeting (htm)
- Final Questions (ppt) (htm)
- Slides (htm)
- Final Minutes (pdf)
- Transcript: Part1(pdf), Part2 (pdf), Part3 (pdf)
July 24, 2007
- Notice of Meeting [txt] [pdf] [pre-pub]
- Nature and Basis Statements of Conflict(s) of Interest
for July 24, 2007 (htm)
- Agenda (pdf)
- Roster (pdf)
- Briefing (htm)
- Slides (htm)
- Transcripts:
- Final Minutes (pdf)
June 27, 2007 Pediatric Subcommittee
May 9-10, 2007
- Notice of Meeting (txt) (pdf)
- Nature and Basis Statements of Conflict(s) of Interest for May 9-10, 2007 (htm) (Updated April 24, 2007 at 1 pm)
- Draft Agenda for May 9, 2007 (pdf)
- Draft Meeting Roster for May 9, 2007 (pdf)
- Committee Roster for May 9-10, 2007 (pdf)
- Briefing Information for May 9, 2007 (htm)
- Draft Agenda for May 10, 2007 (pdf)
- Draft Roster for May 10, 2007 (pdf)
- Briefing Information for May 10, 2007 (htm)
- Posted Questions for May 9, 2007
- Posted Question for May 10, 2007 (ppt) (htm)
- Slides for May 9, 2007 (htm)
- Slides for May 10, 2007 (htm)
- Transcript for May 9, 2007: (Index.pdf), (IndexErrata.pdf), (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf), (ErrataPart4.pdf)
- Transcript for May 10, 2007: (Index.pdf), (Part1.pdf), (Part2.pdf), (Part3.pdf), (Part4.pdf)
- Minutes for May 9, 2007 (pdf)
- Minutes for May 10, 2007 (pdf)
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Peripheral and Central Nervous System Drugs Advisory Committee
Executive Secretary: LT Darrell Lyons, BSN, RN, (HFD-21), 301 827-7001
December 6, 2007
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Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Formerly Advisory Committee for Pharmaceutical Science)
Executive Secretary: Mimi Phan, Pharm.D., (HFD-21), (301) 827-7001
- Change of Name and Function [TXT] [PDF]
May 1-2, 2007
Manufacturing Subcommittee
April 30, 2007
- Notice of Meeting (txt) (pdf)
- Cancellation of Meeting (txt) (pdf )
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Psychopharmacologic Drugs Advisory Committee
Executive Secretary: Cicely Reese, Pharm.D., (HFD-21), (301) 827-7001
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Pulmonary-Allergy Drugs Advisory Committee
Executive Secretary: Teresa Watkins, R.Ph., (HFD-21), (301) 827-7001
May 1, 2007
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Reproductive Health Drugs Advisory Committee
Executive Secretary: Teresa Watkins, R.Ph., (HFD-21), (301) 827-7001
January 23-24, 2007
- Notice of Meeting ( txt) (pdf)
- Nature and Basis Statements of Conflict(s) of Interest (htm)
- Agends for January 23, 2007 Meeting: Draft (pdf), Final (pdf)
- Agends for January 24, 2007 Meeting: Draft (pdf), Final (pdf)
- Rosters: Committee (pdf), Draft (pdf), Final (pdf)
- Questions for January 23, 2007 (htm)
- Questions for January 24, 2007 (htm)
- Briefing Information for January 23-24, 2007 (htm)
- Slides for January 23, 2007 (htm)
- Slides for: January 24, 2007 (htm)
- Minutes for January 23-24, 2007 (pdf)
- Index for January 23, 2007 Transcript (pdf)
- Transcript for January 23, 2007 (pdf)
- Index for January 24, 2007 Transcript (pdf)
- Transcript for January 24, 2007 (pdf)
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February 25, 2008
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