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CDER 2009 Meeting Documents


Anesthetic and Life Support Drugs Advisory Committee
Executive Secretary: Kalyani Bhatt, B.Sc., M.S., (HFD-21), (301) 827-7001

January 30, 2009 (Joiunt meeting with the Drug Safety and Risk Management Advisory Committee) (Meeting ID: 2009-4411)

  • Notice of Meeting (htm)
  • No Waivers for Conflicts of Interest
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Meeting Roster (pdf)
  • Draft Meeting Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Written Statement (htm)
  • Slides (htm)
  • Transcript: Index (pdf), Part1 (pdf)
  • Minutes (pdf)

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Anti-Infective Drugs Advisory Committee
Executive Secretary: Janie Kim, Pharm.D., (HFD-21), (301) 827-7001

June 3, 2009 (Meeting ID: 2009-4426)

June 2, 2009 (Meeting ID: 2209-4425)

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Antiviral Drugs Advisory Committee
Executive Secretary: Paul Tran, R.Ph., HFD-21 (301) 827-7001


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

June 16, 2009 (Meeting ID: 2009-4442)

March 5, 2009 (Meeting ID: 2009-4414)

  • Notice of Meeting (htm) *Meeting Postponed (htm)

Cardiovascular & Renal Drugs Advisory Committee
Executive Secretary: Elaine Ferguson, R.Ph., M.S., (HFD-21), (301) 827-7001

March 19, 2009 (Meeting ID: 2009-4418)

  • Notice of Meeting (html)
  • No Waivers for Conflicts of Interest
  • Agenda (pdf)
  • Roster (pdf)
  • Briefing Information (htm)
  • Questions (pdf)
  • Slides for March 19, 2009 Meeting (htm)
  • Transcript (pdf)

March 18, 2009 (Meeting ID: 2009-4417)

  • Notice of Meeting (htm)
  • No Waivers for Conflicts of Interest
  • Draft Agenda (pdf)
  • Draft Meeting Roster (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Slides for March 18, 2009 Meeting (htm)
  • Transcript (pdf)

February 3, 2009 (Meeting ID: 2009-4412)

  • Notice of Meeting (htm)
  • No Waivers for Conflicts of Interest
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Draft Meeting Roster (pdf)
  • Briefing Information (htm) (Updated 3/5/09)
  • Slides (html)
  • Final Minutes (pdf)
  • Transcript (pdf)

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Dermatologic and Ophthalmic Drugs Advisory Committee
Executive Secretary: LT Yvette Waples, Pharm.D., (HFD-21), (301) 827-7001

 

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Drug Safety and Risk Management Advisory Committee
Executive Secretary: Elaine Ferguson, R.Ph., M.S., (HFD-21), (301) 827-7001

January 30, 2009 (Joiunt meeting with the Anesthetic and Life Support Drugs Advisory Committee) (Meeting ID: 2009-4411)

  • Notice of Meeting (htm)
  • No Waivers for Conflicts of Interest
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Meeting Roster (pdf)
  • Draft Meeting Roster (pdf)
  • Briefing Information (htm)
  • Final Questions (pdf)
  • Written Statement (htm)
  • Slides (htm)
  • Transcript: Index (pdf), Part1 (pdf)
  • Minutes (pdf)

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Endocrinologic and Metabolic Drugs Advisory Committee
Executive Secretary: Paul Tran, R.Ph., (HFD-21), (301) 827-7001

April 1 and 2, 2009 (Meeting ID: 2009-4422)

  • Notice of Meeting
  • Agenda for April 1, 2009 Meeting (pdf)
  • Rosters for April 1, 2009 Meeting: Committee (pdf), Meeting (pdf)
  • Briefing Information for April 1, 2009 Meeting (htm)
  • Questions for April 1, 2009 Meeting (pdf)
  • Agenda for April 2, 2009 Meeting (pdf)
  • Rosters for April 2, 2009 Meeting: Committee (pdf), Meeting (pdf)
  • Briefing Information for April 2, 2009 Meeting (htm)
  • Final Question for April 1, 2009 Meeting (pdf)
  • Final Question for April 2, 2009 Meeting (pdf)
  • Questions for April 2, 2009 Meeting (pdf)
  • Slides for April 1, 2009 Meeting (htm)
  • Slides for April 2, 2009 Meeting (htm)
  • Transcript for April 1, 2009 Meeting (pdf)
  • Transcript for April 2, 2009 Meeting (pdf)

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Gastrointestinal Drugs Advisory Committee
Executive Secretary: Kristine Khuc, Pharm.D., (HFD-21), (301) 827-7001

May 20, 2009 (Meeting ID: 2009-4433)

May 19, 2009 (Meeting ID: 2009-4432)

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

 

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

April 27, 2009 (Joint Meeting with the Pediatric Advisory Committee) (Meeting ID: 2009-4431)

  • Notice of Meeting
  • No Nature and Basis Statements of Conflict(s) of Interest
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Committee Roster (pdf)
  • Rosters: ODAC Committee (pdf), PAC Committee (pdf)
  • Briefing Information (html) (Updated 4/30/09)
  • Presentation Slides (html) (Updated 4/30/09)

March 31, 2009 (Meeting ID: 2009-4427)

  • Notice of Meeting
  • Waivers for Conflict of Interest (htm)
  • Final Agenda (pdf)
  • Draft Agenda (pdf)
  • Final Meeting Roster (pdf)
  • Rosters: Committee (pdf), Meeting (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Final Questions (pdf)
  • Minutes (pdf)
  • Transcript (pdf)

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Pediatric Subcommittee

 

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Peripheral and Central Nervous System Drugs Advisory Committee
Executive Secretary: LCDR Diem-Kieu Ngo, Pharm.D., (HFD-21), 301 827-7001

January 7 and 8, 2009 (Meeting ID: 2009-4396)

  • Notice of Meeting
  • No Waivers for Conflicts of Interest
  • Final Agenda for January 7and 8, 2009 Meeting (pdf)
  • Draft Agenda for January 7and 8, 2009 Meeting (pdf)
  • Final Meeting Roster for January 7and 8, 2009 Meeting (pdf)
  • Rosters for January 7and 8, 2009 Meeting: Members (pdf), Meeting (pdf)
  • Briefing for January 7and 8, 2009 Meeting (htm)
  • Final Questions for January 7and 8, 2009 Meeting (pdf)
  • Draft Questions for January 7and 8, 2009 Meeting (pdf)
  • Sldies for January 7, 2009 Meeting (htm)
  • Sldies for January 8, 2009 Meeting (htm)
  • Final Minutes for January 7, 2009 Meeting (pdf)
  • Final Minutes for January 8, 2009 Meeting (pdf)

 

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Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Formerly Advisory Committee for Pharmaceutical Science)
Executive Secretary: LCDR Sohail Mosaddegh, Pharm.D., (HFD-21), (301) 827-7001

 

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Manufacturing Subcommittee

 

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Psychopharmacologic Drugs Advisory Committee
Executive Secretary: LT Yvette Waples, Pharm.D., HFD-21 (301) 827-7001

April 7 and 8, 2009 (Meeting ID: 2009-4424)

  • Notice of Meeting
  • Posted Agenda for April 7, 2009 Meeting (pdf)
  • Agenda for April 8, 2009 Meeting (pdf)
  • Roster for April 7, 2009 Meeting (pdf)
  • Roster for April 8, 2009 Meeting (pdf)
  • Briefing Information for April 7, 2009 Meeting (htm)
  • Briefing Information for April 8, 2009 Meeting (htm)
  • Questions for April 7, 2009 Meeting (pdf)
  • Questions for April 8, 2009 Meeting (pdf)
  • Transcript for April 7, 2009 Meeting (pdf)
  • Transcript for April 8, 2009 Meeting (pdf)

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Pulmonary-Allergy Drugs Advisory Committee
Executive Secretary: Kristine Khuc, Pharm.D., (HFD-21), (301) 827-7001

February 4, 2009 (Meeting ID: 2009-4413)

  • Notice ofMeeting
  • No Waivers for Conflicts of Interest
  • Draft Agenda (pdf)
  • Draft Meeting Roster (pdf)
  • Briefing Information (htm)
  • Draft Questions (pdf)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript (pdf)

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Reproductive Health Drugs Advisory Committee
Executive Secretary: Kalyani Bhatt, B.Sc., M.S., (HFD-21), (301) 827-7001

 

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Page last updated: May 7, 2009