• Anesthetic and Life Support Drugs Advisory Committee
• Anti-Infective Drugs Advisory Committee
• Antiviral Drugs Advisory Committee
• Arthritis Drugs Advisory Committee
• Cardiovascular & Renal Drugs Advisory Committee
• Dermatologic and Ophthalmic Drugs Advisory Committee
• Drug Safety & Risk Management Advisory Committee
• Endocrinologic and Metabolic Drugs Advisory Committee
• Gastrointestinal Drugs Advisory Committee
• Nonprescription Drugs Advisory Committee
• Oncologic Drugs Advisory Committee
  • Pediatric Subcommittee
• Peripheral and Central Nervous System Drug Advisory Committee
• Pharmaceutical Science Advisory and Clinical Pharmacology Committee (Formerly Advisory Committee for Pharmaceutical Science)
  • Manufacturing Subcommittee
• Psychopharmacologic Drugs Advisory Committee
• Pulmonary-Allergy Drugs Advisory Committee
• Reproductive Health Drugs, Advisory Committee for

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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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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

• Notice of Meeting [TXT] [PDF] [PRE-PUB]
• Nature and Basis Statements of Conflict(s) of Interest for July 30, 2007 Meeting (htm)
• Draft Agenda (pdf)
• Rosters: Meeting Roster (pdf), DSARMAC Roster (pdf), EMDAC Roster (pdf)
• Briefing Information (htm)
• Slides (htm)
• Questions (pdf)
• Minutes (pdf)
• Transcript: (Part1.pdf), (Part2,pdf), (Part3.pdf), (Part4.pdf), (Part5.pdf)

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:
  • Morning: Part 1.pdf, Part 2.pdf
  • Afternoon: Part 3.pdf, Part 4.pdf
• Final Minutes (pdf)

June 27, 2007 Pediatric Subcommittee

• Notice of Meeting (txt) (pdf)
• Nature and Basis Statements of Conflict(s) of Interest (htm)
• Final Agenda (pdf)
• Rosters: Committee (pdf), Meeting (pdf)
• Background (htm)
• Questions: Section 1(ppt, pdf), Section 2 (ppt, pdf)
• Slides (htm)
• Minutes (pdf)
• Transcript (Index.pdf) (Part1.pdf) (Part2.pdf) (Part3.pdf) (Part4.pdf)

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
  • Morning Session (ppt) (htm)
  • Afternoon Session (ppt) (htm)
• 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

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

• Change of Name and Function [TXT] [PDF]

May 1-2, 2007

• Notice of Meeting (txt) (pdf)
• Cancellation of Meeting (txt) (pdf)

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

• Notice of Meeting (txt) (pdf)
• Nature and Basis Statements of Conflict(s) of Interestg (htm)
• Final Agenda (pdf)
• Agenda (pdf)
• Final Meeting Roster (pdf)
• Rosters: Committee (pdf), Meeting (pdf)
• Briefing Information (htm)
• Questions (pdf) (ppt)
• Slides (htm)
• Transcript: (Part 1.pdf), (Part 2.pdf), (Part3.pdf), Index (pdf)
• Minutes (pdf)

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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)