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CDER 2008 Meeting Documents

Anesthetic and Life Support Drugs Advisory Committee
Executive Secretary: Vicky Ferretti-Aceto, Pharm.D., R.Ph., (HFD-21), (301) 827-7001

November 13-14, 2008 (Joint Meeting with the Drug Safety and Risk Management) (Meeting ID: 2008-4395

May 7, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda for May 7, 2008 Meeting (pdf)
  • Briefing Information for May 7, 2008 Meeting (htm)
  • Draft Questions for May 7, 2008 Meeting (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf)

May 5 and 6, 2008 (Joint Meeting with the Drug Safety & Risk Management Advisory Committee)

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda for May 5, 2008 Meeting (pdf)
  • Draft Agenda for May 6, 2008 Meeting (pdf)
  • Briefing Information for May 5, 2008 Meeting (html)
  • Briefing Information for May 6, 2008 Meeting (htm)
  • Draft Questions for May 5, 2008 Meeting (pdf)
  • Draft Questions for May 6, 2008 Meeting (pdf)
  • Slides for May 5, 2008 Meeting (htm)
  • Slides for May 6, 2008 Meeting (htm)
  • Minutes for May 5, 2008 Meeting (pdf)
  • Minutes for May 6, 2008 Meeting (pdf)
  • Transcript for May 5, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for May 6, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

March 11, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for March 4-5, 2008 Meeting (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Committee Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Slides (htm)
  • Transcript: Part 1 (pdf), Part 2 (pdf), Part 3 (pdf)
  • Final Minutes (pdf)

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Anti-Infective Drugs Advisory Committee
Executive Secretary: LT Sohail Mosaddegh, Pharm.D., R.Ph., (HFD-21), (301) 827-7001

July 16, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • No Waivers for Conflicts of Interest
  • Draft Agenda (pdf)
  • Rosters: AIDAC Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

April 1 and 2, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda for April 1 and 2, 2008 Meeting (pdf)
  • Draft Agenda [pdf]
  • Final Roster for April 1 and 2, 2008 Meetings: Committee (pdf), Meeting (pdf)
  • Rosters: Attendee (pdf), Committee (pdf)
  • Briefing Information (htm)
  • Final Questions for April 1 and 2, 2008 Meeting (pdf)
  • Draft Questions (pdf)
  • Slides for April 1, 2008 Meeting (htm)
  • Slides for April 2, 2008 Meeting (htm)
  • Transcripts for April 1, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcripts for April 2, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)

February 27, 2008 : CANCELLED

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Antiviral Drugs Advisory Committee
Executive Secretary: L.Cdr. Diem-Kieu Ngo, Pharm.D., HFD-21 (301) 827-7001

October 30, 2008

  • Notice of Meeting (htm)

October 29, 2008 (Joint Meeting with the Nonprescription Drugs Advisory Committee) (Meeting ID: 2008-4385)

  • Notice of Meeting (htm)
  • Waivers for Conflicts of Interest (htm

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Arthritis Drug Advisory Committee
Executive Secretary: Niclole Vesely, Pharm. D., RPL (HFD-21), (301) 827-7001

November 24, 2008 (Meeting ID: 2008-4387)

July 29, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf)

Cardiovascular & Renal Drugs Advisory Committee
Executive Secretary: Cathy A. Miller, MPH, RN, (HFD-21), (301) 827-7001

December 10, 20088 (Meeting ID: 2008-4390)

June 24, 2008

June 25, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Draft Roster for June 25, 2008 Meeting (pdf)
  • Briefing Information for June 25, 2008 Meeting (htm)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Slides (htm)
  • Minutes (pdf)

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Dermatologic and Ophthalmic Drugs Advisory Committee
Executive Secretary: LT Sohail Mosaddeh, Pharm.D., R.Ph., (HFD-21), (301) 827-7001

June 17 and June 18, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Important Notice - Change in Meeting Location (pdf)
  • Draft Agenda for June 17, 2008 Meeting (pdf)
  • Draft Agenda for June 18, 2008 Meeting (pdf)
  • Rosters for June 17, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Rosters for June 18, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Briefing Information for June 17, 2008 Meeting (htm)
  • Briefing Information for June 18, 2008 Meeting (htm)
  • Addendum to Briefing Material for June 18, 2008 Meeting (pdf)
  • Questions for June 17, 2008 Meeting (pdf)
  • Questions for June 18, 2008 Meeting (pdf)
  • Transcripts for June 17, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcripts for June 18, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

May 29, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Draft Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Transcript (pdf)

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Drug Safety and Risk Management Advisory Committee (Joint Meeting with
Executive Secretary: Vicky Ferretti-Aceto, PharmD, R.Ph. (HFD-21), (301) 827-7001

November 13-14, 2008 (Joint Meeting with the Anesthetic and Life Support Drugs) (Meeting ID: 2008-4395)

May 5 and 6, 2008 (Joint Meeting with the Anesthetic and Life Support Drugs Advisory Committee)

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda for May 5, 2008 Meeting (pdf)
  • Briefing Information for May 5, 2008 Meeting (html)
  • Draft Questions for May 5, 2008 Meeting (pdf)
  • Slides for May 5, 2008 Meeting (htm)
  • Slides for May 6, 2008 Meeting (htm)
  • Minutes for May 5, 2008 Meeting (pdf)
  • Minutes for May 6, 2008 Meeting (pdf)
  • Transcript for May 5, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for May 6, 2008 Meeting: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

February 1, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Amendment Notice [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Draft Agenda (pdf)
  • Final Agenda (pdf)
  • Rosters: Attendee (pdf), Committee (pdf)
  • Final DSaRM Roster (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Final Questions (pdf)
  • Slides (htm)
  • Final Minutes (pdf)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), ERRATA (pdf)

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Endocrinologic and Metabolic Drugs Advisory Committee
Executive Secretary: Cathy A. Miller, MPH, RN, (HFD-21), (301) 827-7001

October 21, 2008 (Meeting ID: 2008-4389)

  • Notice of Meeting (htm)

July 1 and 2, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for July 1 and 2, 2008 Meeting (htm)
  • Agenda for July 1 and 2, 2008 Meeting (pdf)
  • Rosters for July 1 and 2, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Questions for July 1 and 2, 2008 Meeting (pdf)
  • Briefing Information for July 1 and 2, 2008 Meeting (htm)
  • Slides for July 1 & 2, 2008 Meeting (htm)
  • Transcript for July 1, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf), Part5 (pdf)
  • Transcript for July 2, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Minutes for July 1and 2, 2008 Meeting (pdf)

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Gastrointestinal Drugs Advisory Committee
Executive Secretary: Vicky Ferretti-Aceto, PharmD, R.Ph. (HFD-21), (301) 827-7001

January 23, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Final Agenda (pdf)
  • Final Agenda (pdf)
  • Roster (pdf)
  • Briefing Information (html)
  • Final Questions for January 23, 2008 Meeting (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Index (pdf), Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

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Nonprescription Drugs Advisory Committee
Executive Secretary: LT Darrell Lyons, BSN, RN, (HFD-21), (301) 827-7001

October 29, 2008 (Joint Meeting with the Antiviral Drugs Advisory Committee)

  • Notice of Meeting (htm)
  • Waivers for Conflicts of Interest (htm)

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Oncologic Drugs Advisory Committee
Executive Secretary: Niclole Vesely, Pharm. D., RPL (HFD-21), (301) 827-7001

May 30, 2008  

  • Waivers for Conflicts of Interest (html)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Rosters for May 30, 2008 Meeting: Committee (pdf), Meeting (pdf)
  • Briefing Information for May 30, 2008 Meeting (htm)
  • Questions (pdf)
  • Written Statement (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript: Part1 (pdf), Part2 (pdf)

March 12 and 13, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Amendment of Notice [TXT] [PDF] [PRE-PUB]
  • Draft Agenda for March 12, 2008 Meeting (pdf)
  • Draft Agenda for March 13, 2008 Meeting (pdf)
  • Rosters for March 12, 2008 Meeting: Meeting (pdf), Committee (pdf)
  • Rosters for March 13, 2008 Meeting: Meeting (pdf), Committee (pdf)
  • Briefing Information for March 12, 2008 Meeting (htm)
  • Briefing Information for March 13, 2008 Meeting (htm)
  • Final Agenda for March 12, 2008 Meeting (pdf)
  • Final Agenda for March 13, 2008 Meeting (pdf)
  • Final Questions for March 12, 2008 Meeting (pdf) (ppt)
  • Final Questions for March 13, 2008 Meeting (pdf)
  • Slides for March 12, 2008 Meeting (htm)
  • Slides for March 13, 2008 Meeting (htm)
  • Summary Minutes for March 12, 2008 Meeting (doc)
  • Summary Minutes for March 13, 2008 Meeting (doc)
  • Transcript for March 12, 2008: Part 1 (pdf), Part 2 (pdf), Part 3 (pdf)
  • Transcript for March 13, 2008: Part 1 (pdf), Part 2 (pdf), Part 3 (pdf)
  • Written Statements (pdf) (pdf)

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Pediatric Subcommittee

October 23, 2008

April 16, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Final Agenda (pdf)
  • Rosters: Meeting (pdf), Committee (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Final Minutes (pdf)
  • Transcirpt: Part1 (pdf), Part2 (pdf), Part3 (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

October 23, 2008 (Meeting ID: 2008-4382)

  • Notice of Meeting (htm)

August 6 and 7, 2008 (Mtg. ID: 2008-4376) !! MEETING POSTPONED !!

  • Notice of Meeting [TXT] [PDF]

July 10, 2008 Joint Meeting with Psychopharmacologic Drugs Advisory Committe

  • Notice of Meeting [TXT] [PDF]
  • No Waivers for Conflicts of Interest
This is the May 23, 2008 statistical review that describes the anti-epilepsy drugs suicidality metaanalysis conducted by the Agency. We are posting this document before the rest of the FDA background package because of the level of interest in this review. The rest of the background package will be posted when it is available.
  • Briefing Information (htm) (Updated 7/7/08)
  • Draft Agenda (pdf)
  • Rosters: Committee-PCNS (pdf), Committee-PDAC (pdf), Meeting (pdf)
  • Draft Questions (pdf)
  • Briefing Information (pdf)
  • Transcript (pdf)

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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

July 22 and 23, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest for July 22 and 23, 2008 Meeting (html)
  • Final Agenda for July 22 and 23, 2008 Meeting (pdf)
  • Draft Agenda for July 22 and 23, 2008 Meeting (pdf)
    • Clarification of Agenda Item for July 23, 2008 Meeting (html)
  • Rosters for July 22 and 23, 2008 Meeting: Committee (pdf), Public (pdf)
  • Final Questions for July 22 and 23, 2008 Meeting (pdf)
  • Draft Questions for July 22 and 23, 2008 Meeting (pdf)
  • Briefing Information for July 22 and 23, 2008 Meeting (htm)
  • Slides for July 22, 2008 Meeting (htm)
  • Slides for July 23, 2008 Meeting (htm)
  • Transcript for July 22, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)
  • Transcript for July 23, 2008 Meeting: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

March 18 and 19, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Waivers for Conflicts of Interest (htm)
  • Final Agenda for March 18-19, 2008 Meeting (pdf)
  • Meeting Roster for March 18 & 19, 2008 (pdf)
  • Briefing Information or March 18 & 19, 2008 (htm)
  • Questions for March 18, 2008: Disease Model (ppt) (htm), Pediatric Design (ppt) (htm), PGx (ppt) (htm)
  • Questions for March 19, 2008 Meeting (ppt) (htm)
  • Slides for March 18, 2008 Meeting (htm)
  • Slides for March 19, 2008 Meeting (htm)
  • Final Minutes for March 18, 2008 Meeting (pdf)
  • Final Minutes for March 19, 2008 Meeting (pdf)

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Manufacturing Subcommittee

 

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Psychopharmacologic Drugs Advisory Committee
Executive Secretary: L.Cdr. Diem-Kieu Ngo, Pharm.D., HFD-21 (301) 827-7001

July 10, 2008 Joint Meeting with Peripheral and Central Nervous System Drugs Advisory Committee

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • No Waivers for Conflicts of Interest
This is the May 23, 2008 statistical review that describes the anti-epilepsy drugs suicidality metaanalysis conducted by the Agency. We are posting this document before the rest of the FDA background package because of the level of interest in this review. The rest of the background package will be posted when it is available.
  • Briefing Information (htm) (Updated 7/7/08)
  • Draft Agenda (pdf)
  • Rosters: Committee-PCNS (pdf), Committee-PDAC (pdf), Meeting (pdf)
  • Draft Questions (pdf)
  • Briefing Information (pdf)
  • Transcript (pdf)

February 6, 2008

  • Notice of Meeting [TXT] [PDF] [PRE-PUB]
  • Amendment Notice [TXT] [PDF] [PRE-PUB]
  • Nature and Basis Statements of Conflict(s) of Interest for February 6, 2008 Meeting (htm)
  • Draft Agenda (pdf)
  • Final Agenda (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Final Roster (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Final Questions (pdf)
  • Slides (htm)
  • Transcript: Part1 (pdf), Part2 (pdf), Part3 (pdf), Part4 (pdf)

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Pulmonary-Allergy Drugs Advisory Committee
Executive Secretary: Teresa Watkins, R.Ph., (HFD-21), (301) 827-7001

February 20, 2008

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Reproductive Health Drugs Advisory Committee
Executive Secretary: Teresa Watkins, R.Ph., (HFD-21), (301) 827-7001

September 8, 2008

  • Notice of Meeting (html)
  • Agenda (pdf)
  • Roster (pdf)
  • Briefing Information (htm)

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Page last updated: October 14, 2008

 


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