CDER 2004 Meeting Documents

• Anti-Infective 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 & Metabolic Drugs Advisory Committee
• Gastrointestinal Drugs Advisory Committee
• Nonprescription Drugs Advisory Committee
• Pharmaceutical Science, Advisory Committee for
• Psychopharmacologic Drugs Advisory Committee
• Pulmonary-Allergy Drugs Advisory Committee
• Oncologic Drugs Advisory Committee
• Reproductive Health Drugs, Advisory Committee for

• Notice of Meeting (PDF)
• October 14, 2004 Briefing Information
• October 14, 2004 Slides
• October 14, 2004 Transcript (PDF) (Word)
• October 14, 2004 Concordance Index (PDF)

• Notice of Meeting (PDF)
• June 9, 2004 Draft Agenda (PDF) (Word)
• June 9, 2004 Briefing Information
• June 9, 2004 Slides
• June 9, 2004 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• June 9, 2004 Summary Minutes (PDF) (Word)

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

• Notice of Meeting (PDF)
• February 3-4, 2004 Draft Agenda (PDF) (Word)
• February 3-4, 2004 Draft Questions (PDF) (Word)
• February 3-4, 2004 Briefing Information
• February 3, 2004 Slides
• February 3, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• February 4, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• February 3-4, 2004 Summary Minutes (PDF) (Word)

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• February 2, 2004 Briefing Information
• February 2, 2004 Slides
• February 2, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• Errata Sheet (PDF) (Word)
• February 2, 2004 Summary Minutes (PDF) (Word)

[Top]

Arthritis Drug Advisory Committee

Executive Secretary: Kimberly Littleton Topper, MS (HFD-21), (301) 827-7001

June 2-3, 2004

• Notice of Meeting (PDF)
• June 2, 2004 Final Agenda (PDF) (Word)
• June 2, 2004 Draft Agenda (PDF) (Word)
• June 2, 2004 Briefing Information
• June 2, 2004 Errata Sheet (PDF) (Word)
• June 2, 2004 Questions (PDF) (Word)
• June 2, 2004 Slides
• June 2, 2004 Transcripts (PDF) (Word)
• June 2, 2004 Concordance Index (PDF)
• June 3, 2004 Final Agenda (PDF) (Word)
• June 3, 2004 Questions (PDF) (Word)
• June 3, 2004 Slides
• June 3, 2004 Transcripts (PDF) (Word)
• June 2, 2004 Concordance Index (PDF)

[Top]

Cardiovascular & Renal Drugs Advisory Committee

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

September 10, 2004

• Notice of Meeting (PDF)
• September 10, 2004 Draft Agenda (PDF) (Word)
• September 10, 2004 Questions (PDF) (Word)
• September 10, 2004 Briefing Information
• September 10, 2004 Slides
• September 10, 2004 Transcript (PDF) (Word)
• September 10, 2004 Concordance Index (PDF)

[Top]

Dermatologic and Ophthalmic Drugs Advisory Committee

Executive Secretary: Kimberly Littleton Topper, MS (HFD-21), (301) 827-7001

August 27, 2004

• Notice of Meeting (PDF)
• August 27, 2004 Draft Questions (PDF) (Word)
• August 27, 2004 Briefing Information
• August 27, 2004 Slides
• August 27, 2004 Transcript (PDF) (Word)
• August 27, 2004 Concordance Index (PDF)

July 12, 2004 Joint meeting with the Drug Safety and Risk Management Advisory Committee

• Notice of Meeting (PDF)
• July 12, 2004 Briefing Information
• July 12, 2004 Questions ( PDF) (Word)
• July 12, 2004 Slides
• July 12, 2004 Summary Minutes (PDF) (Word)
• July 12, 2004 Transcript (PDF) (Word)
• July 12, 2004 Concordance Index (PDF)
• July 12, 2004 Minutes (PDF) (Word)

May 6-7, 2004 Joint meeting with the Nonprescription Drugs Advisory Committee

• Notice of Meeting (PDF)
• May 6, 2004 Final Agenda (PDF) (Word)
• May 6-7, 2004 Draft Agenda (PDF) (Word)
• May 6-7, 2004 Draft Questions (PDF) (Word)
• May 6-7, 2004 Briefing Information
• May 6, 2004 Slides
• May 6, 2004 Transcript (PDF) (Word)
• May 6, 2004 Corrected Transcript (Word)
  • Concordance Index (PDF)
  • Corrected Cordance Index (PDF)

February 26-27, 2004 Joint meeting with Drug Safety and Risk Management Advisory Committee

• Notice of Meeting (PDF)
• February 26-27, 2004 Agenda (PDF) (Word)
• February 26-27, 2004 DS&RM Committee Roster (PDF) (Word)
• February 26-27, 2004 Derm/Opth Committee Roster (PDF) (Word)
• February 26-27, 2004 Consultants Roster (PDF) (Word)
• February 26-27, 2004 Questions (PDF) (Word)
• February 26-27, 2004 Briefing Information
• February 26, 2004 Slides
• February 26, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• February 27, 2004 Slides
• February 27, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

[Top]

Drug Safety and Risk Management Advisory Committee

Executive Secretary: Shalini Jain, MBA (HFD-21), (301) 827-7001

July 12, 2004 Joint meeting with the Dermatologic & Ophthalmic Drugs Advisory Committee

• Notice of Meeting (PDF)
• July 12, 2004 Briefing Information
• July 12, 2004 Questions ( PDF) (Word)
• July 12, 2004 Slides
• July 12, 2004 Summary Minutes (PDF) (Word)
• July 12, 2004 Transcript (PDF) (Word)
• July 12, 2004 Concordance Index (PDF)
• July 12, 2004 Minutes (PDF) (Word)

May 5, 2004

• Notice of Meeting (PDF)
• May 5, 2004 Draft Questions (PDF) (Word)
• May 5, 2004 Briefing Information
• May 5, 2004 Slides
• May 5, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

February 26-27, 2004 Joint meeting with Dermatologic and Ophthalmic Drugs Advisory Committee

• Notice of Meeting (PDF)
• February 26-27, 2004 Agenda (PDF) (Word)
• February 26-27, 2004 DS&RM Committee Roster (PDF) (Word)
• February 26-27, 2004 Derm/Opth Committee Roster (PDF) (Word)
• February 26-27, 2004 Consultants Roster (PDF) (Word)
• February 26-27, 2004 Questions (PDF) (Word)
• February 26-27, 2004 Briefing Information
• February 26, 2004 Slides
• February 26, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• February 27, 2004 Slides
• February 27, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

[Top]

Endocrinologic & Metabolic Drugs Advisory Committee

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

September 8, 2004

• Notice of Meeting (PDF)
• September 8, 2004 Final Agenda (PDF) (Word)
• September 8, 2004 Draft Agenda (PDF) (Word)
• September 8, 2004 Committee Roster (PDF) (Word)
• September 8, 2004 Briefing Information
• September 8, 2004 Slides
• September 8, 2004 Transcript (PDF) (Word)
• September 8, 2004 Concordance Index (PDF)

[Top]

Gastrointestinal Drugs Advisory Committee

Executive Secretary: Thomas H. Perez, MPH, RPh (HFD-21), (301) 827-7001

July 14, 2004

• Notice of Meeting (PDF)
• July 14, 2004 Briefing Information
• July 14, 2004 Draft Questions (PDF)(Word)
• July 14, 2004 Final Questions (PDF) (Word)
• July 14, 2004 Slides
• July 14, 2004 Summary Minutes (PDF) (Word)
• July 14, 2004 Transcript (PDF) (Word)
• July 14, 2004 Concordance Index (PDF)

[Top]

Nonprescription Drugs Advisory Committee

Executive Secretary: Hilda F. Scharen, MS, (HFD-21), (301) 827-7001

May 6-7, 2004 Joint meeting with the Dermatologic and Ophtholmic Drugs Advisory Committee

• Notice of Meeting (PDF)
• May 6, 2004 Final Agenda (PDF) (Word)
• May 6-7, 2004 Draft Agenda (PDF) (Word)
• May 6-7, 2004 Draft Questions (PDF) (Word)
• May 6-7, 2004 Briefing Information
• May 6, 2004 Slides
• May 6, 2004 Transcript (PDF) (Word)
• May 6, 2004 Corrected Transcript (Word)
  • Concordance Index (PDF)
  • Corrected Concordance Index (PDF)

[Top]

Oncologic Drugs Advisory Committee

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

December 1, 2004

• Notice of Meeting (PDF)
• December 1, 2004 Briefing Information
• December 1, 2004 Slides
• December 1, 2004 Transcript (PDF) (Word)
• December 1, 2004 Concordance Index (PDF)

July 27, 2004

• Notice of Meeting (PDF)
• July 27, 2004 Final Agenda (PDF) (Word)
• July 27, 2004 Final Questions (PDF) (Word)
• July 27, 2004 Briefing Information
• July 27, 2004 Slides
• July 27, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

May 3-4, 2004

• Notice of Meeting (PDF)
• May 3-4, 2004 Final Agenda (PDF) (Word)
• May 3-4, 2004 Draft Agenda (PDF) (Word)
• May 3, 2004 Genasense Questions (PDF) (Word)
• May 3, 2004 RSR13 Questions (PDF) (Word)
• May 3, 2004 Slides
• May 3, 2004 Briefing Information
• May 3, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• May 4, 2004 Briefing Information
• May 4, 2004 Slides
• May 4, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

March 17, 2004 Pediatric Subcommittee

• Notice of Meeting (PDF)
• March 17, 2004 Briefing Information
• March 17, 2004 Slides
• March 17, 2004 Summary Minutes (PDF) (Word)
• March 17, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

[Top]

Pharmaceutical Science, Advisory Committee for

Executive Secretary: Hilda F. Scharen, MS (HFD), (301) 827-7001

November 3-4, 2004 Clinical Pharmacology Subcommittee

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• November 3-4, 2004 Briefing Information
• November 3, 2004 Slides
• November 3, 2004 Transcript (PDF) (Word)
• November 3, 2004 Concordance Index (PDF)
• November 4, 2004 Slides
• November 4, 2004 Transcript (PDF) (Word)
• November 4, 2004 Concordance Index (PDF)
• November 3-4, 2004 Summary Minutes (PDF) (Word)
• November 3-4, 2004 Summary Minutes Errata (PDF) (Word)

October 19-20, 2004

• Notice of Meeting (PDF)
• October 19-20, 2004 Briefing Information
• October 19, 2004 Slides
• October 19, 2004 Transcript (PDF) (Word)
• October 19, 2004 Concordance Index (PDF)
• October 20, 2004 Slides
• October 20, 2004 Transcript (PDF) (Word)
• October Concordance Index (PDF)
• October 19-20, 2004 Summary Minutes (PDF) (Word)

July 20-21, 2004 Manufacturing Subcommittee

• Notice of Meeting (PDF)
• July 20-21, 2004 Draft Agenda (PDF) (Word)
• July 20-21, 2004 Briefing Information
• July 20, 2004 Slides
• July 20, 2004 Transcript (PDF) (Word)
• July 20, 2004 Concordance Index (PDF)
• July 21, 2004 Slides
• July 21, 2004 Transcript (PDF) (Word)
• July 21, 2004 Concordance Index (PDF)
• July 21, 2004 Summary Minutes (PDF) (Word)

April 13-14, 2004

• Notice of Meeting (PDF)
• April 13-14, 2004 Draft Agenda (PDF)(Word)
• April 13-14, 2004 Briefing Information
• April 13, 2004 Slides
• April 13, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• April 14, 2004 Slides
• April 14, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• April 13-14, 2004 Summary Minutes (PDF) (Word)

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• September 13-14, 2004 Final Agenda (PDF) (Word)
• September 13-14, 2004 Draft Agenda (PDF) (Word)
• September 13-14, 2004 Psychopharm Committee Roster (PDF) (Word)
• September 13-14, 2004 Pediatric Committee Roster (PDF) (Word)
• September 13-14, 2004 Guests/Consultants Roster (PDF) (Word)
• September 13-14, 2004 Guests/Consultants Roster - Amendment (PDF) (Word)
• September 13-14, 2004 Questions (PDF) (Word)
• September 13-14, 2004 Briefing Information
• September 13-14, 2004 Addendum to FDA Briefing Information
• September 13-14, 2004 Summary Minutes (PDF) (Word)
• September 13, 2004 Slides
• September 13, 2004 Transcript (PDF) (Word)
• September 13, 2004 Concordance Index (PDF)
• September 14, 2004 Slides
• September 13, 2004 Errata Sheet (PDF) (Word)
• September 13-14, 2004 Errata Sheet (PDF) (Word)
• September 14, 2004 Transcript (PDF) (Word)
• September 14, 2004 Concordance Index (PDF)

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• February 2, 2004 Briefing Information
• February 2, 2004 Slides
• February 2, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)
• Errata Sheet (PDF) (Word)
• February 2, 2004 Summary Minutes (PDF) (Word)

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• June 10, 2004 Briefing Information
• June 10, 2004 Slides
• June 10, 2004 Transcript (PDF) (Word)
• Concordance Index (PDF)

• Notice of Meeting (PDF)
• December 2, 2004 Briefing Information
• December 2, 2004 Slides
• December 2, 2004 Transcript (PDF) (Word)
• December 2, 2004 Concordance Index (PDF)

Page updated: April 5, 2005