• 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
• Nonprescription Drugs Advisory Committee
• Peripheral and Central Nervous System Drug Advisory Committee
• Pharmaceutical Science Advisory Committee
• Psychopharmacologic Drugs Advisory Committee
• Pulmonary-Allergy Drugs Advisory Committee
• Oncologic Drugs Advisory Committee
• Reproductive Health Drugs, Advisory Committee for

Anesthetic and Life Support Drugs Advisory Committee

Executive Secretary: Vicky Ferretti-Aceto, Pharm.D., R.Ph. (HFD-21), (301) 827-7001

November 10, 2005

• Notice of Meeting (pdf) (htm)
• November 10, 2005 Final Agenda (pdf)
• November 10, 2005 Committee Roster (pdf)
• November 10, 2005 Transcript (pdf)
• November 10, 2005 Errata (pdf)
• November 10, 2005 Concordance Index (pdf)

• Notice of Meeting (pdf)
• May 19, 2005 Briefing Information
• May 19, 2005 Final Agenda (pdf) (Word)
• May 19, 2005 Draft Agenda (pdf) (Word)
• May 19, 2005 Committee Roster (pdf) (Word)
• May 19, 2005 Consultants/Guests Roster (pdf) (Word)
• May 19, 2005 Final Questions (pdf) (Word)
• May 19, 2005 Slides
• May 19, 2005 Summary Minutes (pdf) (Word)
• May 19, 2005 Transcript Pages 1-100 (pdf) Pages 101-200 (pdf) Pages 201-300 (pdf) Pages 301-406 (pdf)
• May 19, 2005 Errata (pdf)
• May 19, 2005 Concordance Index (pdf)

• Notice of Meeting (PDF)
• March 11, 2005 Final Agenda (PDF) (Word)
• March 11, 2005 Committee Roster (PDF) (Word)
• March 11, 2005 Consultants/Guests Roster (PDF) (Word)
• March 11, 2005 Questions (PDF) (Word)
• March 11, 2005 Briefing Information (PDF) (Word)
• March 11, 2005 Slides (Word)
• March 11, 2005 Summary Minutes (PDF) (Word)
• March 11, 2005 Transcript (PDF) (Word)
• March 11, 2005 Concordance Index (PDF)

• Notice of Meeting (PDF)
• September 6, 2005 Questions (PDF)
• September 6, 2005 Briefing Information
• September 6, 2005 FDA Briefing Document Errata
• September 6, 2005 Slides
• September 6, 2005 Transcript (PDF)
• September 6, 2005 Concordance Index (PDF)
• September 6, 2005 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• February 16-18, 2005 Final Agenda (PDF) (Word)
• February 16-18, 2005 Arthritis Committee Roster (PDF) (Word)
• February 16-18, 2005 DSaRM Committee Roster (PDF) (Word)
• February 16-18, 2005 Consultants/Guests Roster (PDF) (Word)
• February 16-18, 2005 Discussion Points (PDF) (Word)
• February 16-18, 2005 Briefing Information
• February 16-18, 2005 Addendum to the FDA Briefing Information (PDF) (Word)
• February 16, 2005 Slides
• February 16, 2005 Transcript (PDF) (Word)
• February 16, 2005 Concordance Index (PDF)
• February 17, 2005 Slides
• February 17, 2005 Transcript (PDF) (Word)
• February 17, 2005 Concordance Index (PDF)
• February 18, 2005 Slides
• February 18, 2005 Transcript (PDF) (Word)
• February 18, 2005 Concordance Index (PDF)
• February 16-18, 2005 Summary Minutes (PDF) (Word)

• Notice of Meeting (PDF)
• Nature and Basis Statements of Conflict(s) of Interest
• November 16, 2005 Briefing Information
• November 16, 2005 Slides
• November 16, 2005 Summary Minutes (PDF)
• November 16, 2005 Transcript (PDF)
• November 16, 2005 Concordance Index (PDF)

• Notice of Meeting (PDF)
• June 15, 2005 Final Agenda (PDF) (Word)
• June 15-16, 2005 Committee Roster (PDF)
• June 15, 2005 Consultants/Guests Roster (PDF)
• June 15, 2005 Final Questions (PDF)
• June 15, 2005 Briefing Information
• June 15, 2005 Slides
• June 15, 2005 Transcript (PDF)
• June 15, 2005 Concordance Index (PDF)
• June 15, 2005 Summary Minutes (PDF)
• June 16, 2005 Consultants/Guests Roster (PDF)
• June 16, 2005 Final Questions (PDF)
• June 16, 2005 Briefing Information
• June 16, 2005 Slides
• June 15-16, 2005 Open Public Hearing Statements
• June 16, 2005 Transcript (PDF)
• June 16, 2005 Concordance Index (PDF)
• June 16, 2005 Summary Minutes (PDF)

• Notice of Meeting (PDF)
• Notice of Cancellation (PDF)

• Notice of Meeting (PDF)
• February 24, 2005 Final Agenda (PDF)
• February 24, 2005 Committee Roster (PDF)
• February 24, 2005 Consultants/Guests Roster (PDF)
• February 24, 2005 Briefing Information
• February 24, 2005 Slides
• February 24, 2005 Summary Minutes (PDF) (Word)
• February 24, 2005 Transcript (PDF) (Word)

• Notice of Meeting (PDF)
• March 24, 2005 Final Agenda (PDF)
• March 24, 2005 NDAC Committee Roster (PDF)
• March 24, 2005 DODAC Committee Roster (PDF)
• March 24, 2005 Consultants/Guests Roster (PDF)
• March 24, 2005 Briefing Information (PDF) (Word)
• March 24, 2005 Slides (Word)
• March 24, 2005 Errata to the Transcript (PDF) (Word)
• March 24, 2005 Transcript (PDF) (Word)
• March 24, 2005 Concordance Index (PDF)

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• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• May 18-19, 2005 Final Agenda (PDF) (Word)
• May 18-19, 2005 Committee Roster (PDF) (Word)
• May 18-19, 2005 Participants Roster (PDF) (Word)
• May 18-19, 2005 Briefing Information
• May 18, 2005 Questions (PDF) (Word)
• May 18, 2005 Slides
• May 18, 2005 Transcript (PDF)
• May 18, 2005 Concordance Index (PDF)
• May 19, 2005 Questions (PDF) (Word)
• May 19, 2005 Slides
• May 19, 2005 Transcript (PDF)
• May 19, 2005 Concordance Index (PDF)

• Notice of Meeting (PDF)
• February 16-18, 2005 Final Agenda (PDF) (Word)
• February 16-18, 2005 Arthritis Committee Roster (PDF) (Word)
• February 16-18, 2005 DSaRM Committee Roster (PDF) (Word)
• February 16-18, 2005 Consultants/Guests Roster (PDF) (Word)
• February 16-18, 2005 Discussion Points (PDF) (Word)
• February 16-18, 2005 Briefing Information
• February 16-18, 2005 Addendum to the FDA Briefing Information (PDF) (Word)
• February 16, 2005 Slides
• February 16, 2005 Transcript (PDF) (Word)
• February 16, 2005 Concordance Index (PDF)
• February 17, 2005 Slides
• February 17, 2005 Transcript (PDF) (Word)
• February 17, 2005 Concordance Index (PDF)
• February 18, 2005 Slides
• February 18, 2005 Transcript (PDF) (Word)
• February 18, 2005 Concordance Index (PDF)
• February 16-18, 2005 Summary Minutes (PDF) (Word)

Executive Secretary: Cathy Groupe, RN, BSN, (HFD-21), (301) 827-7001

September 8-9, 2005

• Notice of Meeting (PDF)
• September 8, 2005 Final Agenda (PDF)
• Setember 8-9, 2005 Committee Roster (PDF)
• September 8, 2005 Consultants/Guests Roster (PDF)
• September 8, Final Questions (PDF)
• September 8, 2005 Briefing Information
• September 8, 2005 Slides
• September 8, 2005 Summary Minutes (PDF)
• September 8, 2005 Transcript (PDF)
• September Concordance Index (PDF)
• September 9, 2005 Final Agenda (PDF)
• September 9, 2005 Consultants/Guests Roster (PDF)
• September 9, Final Questions (PDF)
• September 9, 2005 Briefing Information
• September 9, 2005 Slides
• September 9, 2005 Summary Minutes (PDF)
• September 9, 2005 Transcript (PDF)
• September 9, 2005 Concordance Index (PDF)

January 13-14, 2005 Joint meeting with the Nonprescription Drugs Advisory Committee

• Notice of Meeting (PDF)
• January 13-14, 2005 Final Agenda (PDF)
• January 13-14, 2005 Briefing Information
• January 13-14, 2005 Questions [htm] [pdf] [ppt]
• January 13-14, 2005 Committee Roster (PDF)
• January 13-14, 2005 Consultants/Guests Roster (PDF)
• January 13, 2005 Slides
• January 13, 2005 Transcript (PDF) (Word)
• January 13, 2005 Concordance Index (PDF)
• January 14, 2005 Slides
• January 14, 2005 Transcript (PDF) (Word)
• January 14, 2005 Concordance Index (PDF)
• January 13-14, 2005 Summary Minutes (PDF) (Word)

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Nonprescription Drugs Advisory Committee

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

October 20-21, 2005

• Notice of Meeting (PDF)
• October 20, 2005 Final Agenda (PDF)
• October 20, 2005 Final Questions (PDF)
• October 20, 2005 Briefing Information
• October 20, 2005 Committee Roster (PDF)
• October 20, 2005 Consultants/Guests Roster (PDF)
• October 20, 2005 Final Questions (PDF)
• October 20, 2005 Slides
• October 20, 2005 Summary Minutes (PDF)
• October 20, 2005 Transcript (PDF)

March 24, 2005 Joint Meeting with the Dermatologic & Ophthalmic Drugs Advisory Committee

• Notice of Meeting (PDF)
• March 24, 2005 Final Agenda (PDF)
• March 24, 2005 NDAC Committee Roster (PDF)
• March 24, 2005 DODAC Committee Roster (PDF)
• March 24, 2005 Consultants/Guests Roster (PDF)
• March 24, 2005 Briefing Information (PDF) (Word)
• March 24, 2005 Slides (Word)
• Notice of Meeting (PDF)
• March 24, 2005 Briefing Information (PDF) (Word)
• March 24, 2005 Slides (Word)
• March 24, 2005 Errata to the Transcript (PDF) (Word)
• March 24, 2005 Transcript (PDF) (Word)
• March 24, 2005 Concordance Index (PDF)

March 23, 2005

• Notice of Meeting (PDF)
• March 23, 2005 Final Agenda (PDF) (Word)
• March 23, 2005 Questions (PDF) (Word)
• March 23, 2005 Briefing Information (PDF) (Word)
• March 23, 2005 Slides (Word)
• March 23, 2005 Transcript (PDF) (Word)
• March 23, 2005 Concordance Index (PDF)

January 13-14, 2005 Joint meeting with the Endocrinologic and Metabolic Drugs Advisory Committee

• Notice of Meeting (PDF)
• January 13-14, 2005 Final Agenda (PDF)
• January 13-14, 2005 Briefing Information
• January 13-14, 2005 Questions [htm] [pdf] [ppt]
• January 13-14, 2005 Committee Roster (PDF)
• January 13-14, 2005 Consultants/Guests Roster (PDF)
• January 13, 2005 Slides
• January 13, 2005 Transcript (PDF) (Word)
• January 13, 2005 Concordance Index (PDF)
• January 14, 2005 Slides
• January 14, 2005 Transcript (PDF) (Word)
• January 14, 2005 Concordance Index (PDF)
• January 13-14, 2005 Summary Minutes (PDF) (Word)

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Oncologic Drugs Advisory Committee

Executive Secretary: Johanna M. Clifford, MS, RN, (HFD-21), (301) 827-7001

November 8, 2005

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• November 8, 2005 Briefing Information
• November 8, 2005 Slides
• November 8, 2005 Transcript (PDF)
• November 8, 2005 Concordance Index (PDF)

October 20, 2005 Pediatric Oncology Subcommittee

• Notice of Meeting (PDF)
• October 20, 2005 Final Agenda (PDF)
• October 20, 2005 Committee Roster (PDF)
• October 20. 2005 Consultants/Guests Roster (PDF)
• October 20, 2005 Final Questions (PDF)
• October 20, 2005 Briefing Information
• October 20, 2005 Slides
• October 20, 2005 Summary Minutes (PDF)
• October 20, 2005 Transcript (PDF)
• October 20, 2005 Concordance Index (PDF)

September 13-14, 2005

• Notice of Meeting (PDF)
• September 13, 2005 Final Agenda (PDF)
• September 13, 2005 Committee Roster (PDF)
• September 13, 2005 Consultants/Guests Roster (PDF)
• September 13, 2005 Briefing Information
• September 13, 2005 Slides
• September 13, 2005 Questions - Xinlay (PDF)
• September 13, 2005 Questions - Tarveva (PDF)
• September 13, 2005 Transcript Pages 1-100 (PDF) Pages 101-200 (PDF) Pages 201-300 (PDF) Pages 300-368 (PDF)
• September 13, 2005 Concordance Index (PDF)
• September 14, 2005 Briefing Information
• September 14, 2005 Questions - Revlimid (PDF)
• September 14, 2005 Questions - Arranon (PDF)
• September 14, 2005 Transcript Pages 1-100 (PDF) Pages 101-200 (PDF) Pages 201-300 (PDF) Pages 301-356 (PDF)
• September 14, 2005 Concordance Index (PDF)
• September 14, 2005 Slides

May 5, 2005

• Notice of Meeting (PDF)
• May 5, 2005 Briefing Information
• May 5, 2005 Slides (Word)
• May 5, 2005 Transcript (PDF) (Word)
• May 5, 2005 Concordance Index (PDF)

March 3-4, 2005

• Notice of Meeting (PDF)
• March 3, 3005 Final Agenda (PDF)
• March 3, 2005 Committee Roster (PDF)
• March 3, 2005 Consultants/Guests Roster (PDF)
• March 3, 2005 Combidex Questions (PDF)
• March 3, 2005 Iressa Questions (PDF)
• March 3, 2005 Briefing Information
• March 3, 2005 Slides (PDF) (Word)
• March 3, 2005 Transcript (PDF) (Word)
• March 3, 2005 Concordance Index (PDF)
• March 4, 2005 Prostate Cancer Endpoint Questions (PDF)
• March 4, 2005 Zometa-Aredia Questions (PDF)
• March 4, 2005 Briefing Information
• March 4, 2005 Slides (PDF) (Word)
• March 4, 2005 Transcript (PDF) (Word)
• March 4, 2005 Concordance Index (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

August 4, 2005

• Notice of Meeting (PDF)
• August 4, 2005 Final Agenda (PDF)
• August 4, 2005 Committee Roster (PDF)
• August 4, 2005 Consultants/Guests Roster (PDF)
• August 4, 2005 Questions (PDF)
• August 4, 2005 Briefing Information
• August 4, 2005 Slides
• August 4, 2005 Transcript (PDF) (Word)
• August 4, 2005 Concordance Index (PDF)
• August 4, 2005 Errata (PDF)
• August 4, 2005 Summary Minutes (PDF) (Word)

Pharmaceutical Science Advisory Committee

Executive Secretary: Mimi Phan, Pharm.D., (HFD-21), (301) 827-7001

November 14-15, 2005 Clinical Pharmacology Subcommittee

• Notice of Meeting (pdf)
• Nature and Basis Statements of Conflict(s) of Interest
• November 14-15, 2005 Briefing Information
• November 14, 2005 Slides
• November 14, 2005 Transcript, Concordance Index
• November 15, 2005 Slides
• November 15, 2005 Transcript, Concordance Index
• November 14-15, 2005 Summary Minute(pdf)

October 25-26, 2005

• Notice of Meeting (PDF)
• October 25-26, 2005 Briefing Information
• October 25, 2005 Slides
• October 25, 2005 Transcript (PDF)
• October 25, 2005 Concordance Index (PDF)
• October 26, 2005 Transcript (PDF)
• October 26, 2005 Concordance Index (PDF)
• October 25-26, 2005 Summary Minutes
• October 26, 2005 Slides

May 3-4, 2005

• Notice of Meeting (PDF)
• May 3-4, 2005 Briefing Information (Word)
• May 3, 2005 Slides (Word)
• May 3, 2005 Transcript (PDF) (Word)
• May 3, 2005 Concordance Index (PDF)
• May 4, 2005 Slides (Word)
• May 4, 2005 Transcript (PDF) (Word)
• May 4, 2005 Concordance Index (PDF)
• May 3-4, 2005 Summary Minutes (PDF) (Word)
• May3-4, 2005 Errata to the Summary Minutes (PDF)

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Psychopharmacologic Drugs Advisory Committee

Executive Secretary: Cicely Reese, Pharm.D., (HFD-21), (301) 827-7001

December 2, 2005

• Notice of Meeting (PDF)
• Nature and Basis Statements for Conflict of Interest Waivers
• December 2, 2005 Final Agenda (PDF)
• December 2, 2005 Committee Roster (PDF)
• December 2, 2005 Consultants Roster (PDF)
• December 2, 2005 Briefing Information
• December 2, 2005 Slides
• December 2, 2005 Public Statements
• December 2, 2005 Transcript (PDF)
• December 2, Concordance Index (PDF)
• December 2, 2005 Summary Minutes (PDF)

October 25-26, 2005

• Notice of Meeting (PDF)
• October 25, 2005 Briefing Information
• October 25, 2005 Slides
• October 25, 2005 Transcript (PDF)
• October 25, 2005 Concordance Index (PDF)
• October 26, 2005 Briefing Information
• October 26, 2005 Slides
• October 26, 2005 Transcript (PDF)
• October 26, 2005 Erratta (PDF)
• October 26, 2005 Concordance Index (PDF)
• October 25-26, 2005 Summary Minutes (PDF)

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Pulmonary-Allergy Drugs Advisory Committee

Executive Secretary: Teresa Watkins, R.Ph., (HFD-21), (301) 827-7001

July 13-14, 2005

• Notice of Meeting (PDF)
• July 13, 2005 Briefing Information
• July 13, 2005 Slides
• July 13, 2005 Transcript (PDF) (Word)
• July 13, 2005 Summary Minutes (PDF)
• July 14, 2005 Briefing Information
• July 14, 2005 Slides
• July 14, 2005 Transcript (PDF) (Word)
• July 14, 2005 Concordance Index (PDF)
• July 14, 2005 Summary Minutes (PDF)

June 6, 2005

• Notice of Meeting (PDF)
• June 6, 2005 Briefing Information
• June 6, 2005 Slides
• June 6, 2005 Transcript (PDF) (Word)
• June 6, 2005 Concordance Index (PDF)
• June 6, 2005 Summary Minutes (PDF)

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Page updated: September 18, 2007