CDER 2003 Meeting Documents

Anesthetic & Life Support Drugs Advisory Committee

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

November 18-19, 2003

September 9-10, 2003

• Notice of Meeting (PDF)
• Notice of Amendment (PDF)
• September 9-10, 2003 Draft Agenda (PDF) (Word)
• September 9-10, 2003 Briefing Information
• September 9, 2003 Slides
• September 9, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 10, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 10, 2003 Slides
• September 9-10, 2003 Summary Minutes (PDF)

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Anti-Infective Drugs Advisory Committee

Executive Secretary: Tara P. Turner, Pharm.D. (HFD-21), (301) 827-7001

October 29-30, 2003 Pediatric Subcommittee

October 28-29, 2003

June 11-12, 2003 Pediatric Subcommittee

• Notice of Meeting (PDF)
• Committee Roster
• Special Government Employees - Consultants Roster
• June 11, 2003 Draft Agenda (PDF) (Word)
• June 11, 2003 Questions
• June 11, 2003 Briefing Information
• June 11, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• June 11, 2003 Slides
• June 12, 2003 Draft Agenda (PDF) (Word)
• June 12, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• June 12, 2003 Slides
• Summary Minutes

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March 4-6, 2003

• Notice of Meeting (PDF)
• March 4, 2003 Agenda (PDF) (Word)
• March 4, 2003 Committee Members Roster (PDF) (Word)
• March 4, 2003 Consultants/Guests Roster (PDF) (Word)
• March 4, 2003 Questions (PDF) (Word)
• March 4, 2003 Briefing Information
• March 4, 2003 Slides
• March 4, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 5, 2003 Agenda (PDF) (Word)
• March 5, 2003 Committee Members Roster (PDF) (Word)
• March 5, 2003 Consultants/Guests (PDF) (Word)
• March 5, 2003 Briefing Information
• March 5, 2003 Slides
• March 5, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

March 3, 2003 Pediatric Subcommittee

• Notice of Meeting (PDF)
• March 3, 2003 Final Agenda (PDF) (Word)
• March 3, 2003 Draft Agenda (PDF) (Word)
• March 3, 2003 Final Questions (PDF) (Word)
• March 3, 2003 Draft Questions (PDF) (Word)
• March 3, 2003 Committee Roster (PDF) (Word)
• March 3, 2003 Consultants/Guests Roster (PDF) (Word)
• March 3, 2003 Briefing Information
• March 3, 2003 Slides
• March 3, 2003 Transcript (PDF) (Word)
  • (Concordance Index (PDF)
• March 3, 2003 Minutes (PDF) (Word)

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January 8-9, 2003

• Notice of Meeting (PDF)
• January 8, 2003 Draft Agenda (PDF) (Word)
• January 8, 2003 Final Agenda (PDF) (Word)
• January 8, 2003 Committee Roster (PDF) (Word)
• January 8, 2003 Consultants/Guests Roster (PDF) (Word)
• January 8, 2003 Questions (PDF) (Word)
• January 8, 2003 Briefing Information
• January 8, 2003 Erratum (PDF)
• January 8, 2003 Slides
• January 8, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• January 9, 2003 Final Agenda (PDF) (Word)
• January 9, 2003 Committee Roster (PDF)
• January 9, 2003 Consultants-Guests Roster (PDF) (Word)
• January 9, 2003 Questions (PDF) (Word)
• January 9, 2003 Background Information
• January 9, 2003 Slides
• January 9, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Antiviral Drugs Advisory Committee

Executive Secretary: Tara P. Turner, Pharm.D. (HFD-21), (301) 827-7001

August 20, 2003

• Notice of Meeting (PDF)
• August 20, 2003 Final Agenda (PDF) (Word)
• August 20, 2003 Draft Agenda (PDF) (Word)
• August 20, 2003 Committee Roster (PDF) (Word)
• August 20, 2003 Guests/Consultants Roster (PDF) (Word)
• August 20, 2003 Final Questions (PDF) (Word)
• August 20, 2003 Draft Questions (PDF) (Word)
• August 20, 2003 Briefing Informaton
• August 20, 2003 Slides
• August 20, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

May 13-14, 2003

• Notice of Meeting (PDF)
• May 13, 2003 Final Agenda (PDF) (Word)
• May 13, 2003 Draft Agenda (PDF) (Word)
• May 13, 2003 Committee Roster (PDF) (Word)
• May 13, 2003 Additional Participants (PDF) (Word)
• May 13, 2003 Final Questions (PDF) (Word)
• May 13, 2003 Briefing Information
• May 13, 2003 Slides
• May 13, 2003 Transcript (PDF) (Word)
  • May 13, 2003 Concordance Index (PDF)
• May 14, 2003 Final Agenda (PDF) (Word)
• May 14, 2003 Draft Agenda (PDF) (Word)
• May 14, 2003 Committee Roster (PDF) (Word)
• May 14, 2003 Additional Participants (PDF) (Word)
• May 14, 2003 Final Questions (PDF) (Word)
• May 14, 2003 Briefing Information
• May 14, 2003 Slides
• May 14, 2003 Transcript (PDF) (Word)
  • May 14, 2003 Concordanc Index (PDF)

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Arthritis Advisory Committee

Executive Secretary: Kimberly Littleton Topper, MS (HFD-21), (301) 287-7001

September 29-30, 2003

• Notice of Meeting (PDF)
• September 29-30, 2003 Briefing Information (PDF) (Word)
• September 29, 2003 Slides
• September 29, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 30, 2003 Slides
• September 30, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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June 23-24, 2003

• Notice of Meeting (PDF)
• June 23-24, 2003 Draft Agenda (PDF) (Word)
• June 23, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• June 23, 2003 Slides
• June 24, 2003 Briefing Information
• June 24, 2003 Slides
• June 24, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

March 4-5, 2003

• Notice of Meeting (PDF)
• March 4, 2003 Agenda (PDF) (Word)
• March 4, 2003 Committee Members Roster (PDF) (Word)
• March 4, 2003 Consultants/Guests Roster (PDF) (Word)
• March 4, 2003 Open Public Hearing Speakers (PDF) (Word)
• March 4, 2003 Questions (PDF) (Word)
• March 4, 2003 Briefing Information
• March 4, 2003 Slides
• March 4, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 5, 2002 Agenda (PDF) (Word)
• March 5, 2003 Committee Members Roster (PDF) (Word)
• March 5, 2003 Consultants/Guests Roster (PDF) (Word)
• March 5, 2003 Open Public Hearing Speakers (PDF) (Word)
• March 5, 2003 Questions (PDF) (Word)
• March 5, 2003 Briefing Information
• March 5, 2003 Slides
• March 5, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Cardiovascular and Renal Drugs Advisory Committee

Executive Secretary: Dornette Spell-LeSane, NP-C, MHA (HFD-21), (301) 827-7001

December 8-9, 2003

May 29-30, 2003

• Notice of Meeting (PDF)
• May 29, 2003 Final Agenda (PDF) (Word)
• May 29, 2003 Final Questions (PDF) (Word)
• May 29, 2003 Briefing Information
• May 29, 2003 Slides
• May 29, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

January 6-7, 2003

• Notice of Meeting (PDF)
• January 6, 2003 Final Agenda (PDF) (Word)
• January 6, 2003 Questions (PDF) (Word)
• January 6, 2003 Briefing Information
• January 6, 2003 Slides
• January 6, 2003 Transcript (PDF) (Word)
• January 6, 2003 Concordance Index (PDF)
• January 7, 2003 Final Agenda (PDF) (Word)
• January 7, 2003 Questions (PDF) (Word)
• January 7, 2003 Briefing Information
• January 7, 2003 Slides
• January 7, 2003 Transcript (PDF) (Word)
• January 7, 2003 Concordance Index (PDF)

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Dermatologic and Ophthalmic Drugs Advisory Committee

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

September 25, 2003

• Notice of Meeting (PDF)
• September 25, 2003 Briefing Information
• September 25, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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September 9-10, 2003

• Notice of Meeting (PDF)
• September 9, 2003 Draft Agenda (PDF) (Word)
• September 9, 2003 Discussion Topics (PDF) (Word)
• September 9, 2003 Participants Roster (PDF) (Word)
• September 9, 2003 Briefing Information
• September 9, 2003 Slides
• September 9, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 10, 2003 Draft Agenda (PDF) (Word)
• September 10, 2003 Participants Roster (PDF) (Word)
• September 10, 2003 Briefing Information
• September 10, 2003 Slides
• September 10, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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March 17, 2003

• Notice of Meeting (PDF)
• March 17, 2003 Briefing Information
• March 17, 2003 Draft Questions (PDF) (Word)
• March 17, 2003 Slides
• March 17, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Drug Safety and Risk Management Advisory Committee

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

December 4, 2003

September 19, 2003 Postponed

• Notice of Meeting (PDF)
• September 19, 2003 Draft Agenda (PDF) (Word)
• September 19, 2003 Draft Questions (PDF) (Word)
• September 19, 2003 Briefing Information

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September 18, 2003 Postponed

• Notice of Meeting (PDF)
• Amended Notice of Meeting (PDF)
• September 18, 2003 Draft Questions (PDF) (Word)
• September 18, 2003 Briefing Information

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Endocrinologic and Metabolic Drugs Advisory Committee

Executive Secretary: Dornette Spell-LeSane, NP-C, MHA (HFD-21) (301) 827-7001

October 7, 2003

• Notice of Meeting (PDF)
• October 7, 2003 Agenda (PDF) (Word)
• October 7, 2003 Committee Roster (PDF) (Word)
• October 7, 2003 Consultants/Guests Roster (PDF) (Word)
• October 7, 2003 Briefing Information
• October 7, 2003 Slides
• October 7, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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July 9, 2003

• Notice of Meeting (PDF)
• July 9, 2003 Final Agenda (PDF) (Word)
• July 9, 2003 Draft Agenda (PDF) (Word)
• July 9, 2003 Committee Roster (PDF) (Word)
• July 9, 2003 Consultants/Guests Roster (PDF) (Word)
• July 9, 2003 Final Questions (PDF) (Word)
• July 9, 2003 Draft Questions (PDF) (Word)
• July 9, 2003 Briefing Information
• July 9, 2003 Slides
• July 9, 2003 Transcripts (PDF) (Word)
  • Concordance Index (PDF)

June 10, 2003

• Notice of Meeting (PDF)
• June 10, 2003 Draft Agenda (PDF) (Word)
• June 10, 2003 Draft Questions (PDF) (Word)
• June 10, 2003 Committee Roster (PDF) (Word)
• June 10, 2003 Consultants-Guests Roster (PDF) (Word)
• June 10, 2003 Briefing Information
• June 10, 2003 Slides
• June 10, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

January 13-15, 2003

• Notice of Meeting (PDF)
• January 13, 2003 Roster (PDF) (Word)
• January 13, 2003 Consultants and Guests (PDF) (Word)
• January 13, 2003 Open Public Hearing Speaker (PDF) (Word)
• January 13, 2003 Draft Agenda (PDF) (Word)
• January 13, 2003 Briefing Information
• January 13, 2003 Preliminary Discussion Topics (PDF) (Word)
• January 13, 2003 Final Questions to the Committee (PDF) (Word)
• January 13, 2003 Slides
• January 13, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• January 14, 2003 Committee Roster (PDF) (Word)
• January 14, 2003 Consultants and Guest Roster (PDF) (Word)
• January 14, 2003 Open Public Hearing Speakers (PDF) (Word)
• January 14, 2003 Preliminary Discussion Topics (PDF) (Word)
• January 14, 2003 Final Questions (PDF) (Word)
• January 14, 2003 Briefing Information
• January 14, 2003 Slides
• January 14, 2003 Transcript (PDF) (Word)
  • Condorance Index (PDF)
• January 15, 2003 Open Public Hearing Speakers (PDF) (Word)
• January 15, 2003 Preliminary Discussion Topics (PDF) (Word)
• January 15, 2003 Final Questions (PDF)
• January 15, 2003 Briefing Information
• January 15, 2003 Errata (PDF) (Word)
• January 15, 2003 Slides
• January 15, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Gastrointestinal Drugs Advisory Committee

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

June 25-26, 2003

• Notice of Meeting (PDF)
• June 25, 2003 Final Agenda (PDF) (Word)
• June 25, 2003 Questions (PDF) (Word)
• June 25, 2003 Briefing Information
• June 25, 2003 Slides
• June 25, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• June 26, 2003 Final Agenda (PDF) (Word)
• June 26, 2003 Questions (PDF) (Word)
• June 26, 2003 Briefing Information
• June 26, 2003 Slides
• June 26, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

March 6, 2003

• Notice of Meeting (PDF)
• March 6, 2003 Committee Member Roster (PDF) (Word)
• March 6, 2003 Questions (PDF) (Word)
• March 6, 2003 Briefing Information
• March 6, 2003 Slides
• March 6, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 6, 2003 Minutes (PDF) (Word)

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Nonprescription Drugs Advisory Committee

Executive Secretary: Karen M. Templeton-Somers, PhD (HFD-21), (301) 827-7001

• Notice of Meeting (PDF)
• December 16, 2003 Final Agenda (PDF) (Word)
• December 16, 2003 Nonprescription Committee Roster (PDF) (Word)
• December 16, 2003 Reproductive Committee Roster (PDF) (Word)
• December 16, 2003 Consultants & Guests Roster (PDF) (Word)
• December 16, 2003 Final Questions (PDF) (Word)
• December 16, 2003 Draft Discussion Points (PDF) (Word)
• December 16, 2003 Briefing Information
• December 16, 2003 Slides
• December 16, 2003 Transcript (PDF) (Word)
  • Errata (PDF) (Word)
  • Concordance Index (PDF)

June 12, 2003

• Notice of Meeting (PDF)
• June 12, 2003 Final Agenda (PDF) (Word)
• June 12, 2003 Committee Roster (PDF) (Word)
• June 12, 2003 Guests Roster (PDF) (Word)
• June 12, 2003 Questions (PDF) (Word)
• June 12, 2003 Briefing Information
• June 12, 2003 Slides
• June 12, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Oncologic Drugs Advisory Committee

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

December 16, 2003

October 9, 2003 Pediatric Oncology Subcommittee

July 15, 2003 Pediatric Oncology Subcommittee

• Notice of Meeting (PDF)
• July 15, 2003 Briefing Information
• July 15, 2003 Slides
• July 15, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• July 15, 2003 Minutes (PDF) (Word)

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March 12-13, 2003

• Notice of Meeting (PDF)
• March 12-13, 2003 Final Agenda (PDF) (Word)
• March 12-13, 2003 Draft Agenda (PDF) (Word)
• March 12, 2003 Briefing Information
• March 12, 2003 Slides
• March 12, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 13, 2003 Briefing Information
• March 13, 2003 Slides
• March 13, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

March 4, 2003 Pediatric Oncology Subcommittee

• Notice of Meeting (PDF)
• March 4, 2003 Final Agenda (PDF) (Word)
• March 4, 2003 Committee Roster (PDF) (Word)
• March 4, 2003 Consultants/Guests Roster (PDF) (Word)
• March 4, 2003 Questions (PDF) (Word)
• March 4, 2003 Briefing Information
• March 4, 2003 Sides
• March 4, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 4, 2003 Minutes (PDF)  (Word)

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Peripheral and Central Nervous System Drugs Advisory Committee

Executive Secretary: Anuja M. Patel, MPH (HFD-21), (301) 827-7001

September 24-25, 2003

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• September 24, 2003 Draft Agenda (PDF) (Word)
• September 24, 2003 Briefing Information
• September 24, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 24, 2003 Summary Minutes (PDF) (htm)
• September 25, 2003 Draft Agenda (PDF) (Word)
• September 25, 2003 Briefing Information
• September 25, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 25, 2003 Summary Minutes (PDF) (htm)

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May 16, 2002 [Cancelled]

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

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Pharmaceutical Science, Advisory Committee for

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

November 17-18, 2003 Clinical Pharmacology Subcommittee

October 21-22, 2003

September 17-18, 2003 Manufacturing Subcommittee

• Notice of Meeting (PDF)
• Amendment of Notice (PDF)
• September 17, 2003 Draft Agenda (PDF) (Word)
• September 17, 2003 Committee Roster (PDF) (Word)
• September 17, 2003 Subcommittee Roster (PDF) (Word)
• September 17, 2003 Briefing Information
• September 17, 2003 Slides
• September 17, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 17, 2003 Summary Minutes (PDF) (Word)

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June 10, 2003 Pharmacology and Toxicology Subcommittee

• Notice of Meeting (PDF)
• June 10, 2003 Draft Agenda (PDF) (Word)
• June 10, 2003 Questions (PDF) (Word)
• June 10, 2003 Briefing Information
• June 10, 2003 Slides
• June 10, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

May 21-22, 2003 Manufacturing Subcommittee

• Notice of Meeting (PDF)
• May 21-22, 2003 Draft Agenda (PDF) (Word)
• May 21-22, 2003 Briefing Information
• May 21, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• May 21, 2003 Slides
• May 22, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• May 22, 2003 Slides

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April 22-23, 2003 Clinical Pharmacology Subcommittee

• Notice of Meeting (PDF)
• April 22, 2003 Draft Agenda (PDF) (Word)
• April 22, 2003 Questions (PDF) (Word)
• April 22, 2003 Subcommittee Roster (PDF) (Word)
• April 22, 2003 Guests Roster (PDF) (Word)
• April 22, 2003 Slides
• April 22, 2003 Transcript (Word) Part I (PDF) Part II (PDF) Part III (PDF)
  • April 22, 2003 Concordance Index
• April 23, 2003 Draft Agenda (PDF) (Word)
• April 23, 2003 Slides
• April 23, 2003 Transcript (Word) Part I (PDF) Part II (PDF)
  • April 23, 2003 Concordance Index (PDF)

March 21, 2003 Manufacturing Subcommittee [ Cancelled ]

• Notice of Meeting (PDF)
• March 21, 2003 Draft Agenda (PDF) (Word)
• March 21, 2003 Subcommittee Roster (PDF) (Word)
• March 21, 2003 Briefing Information

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March 12-13, 2003

• Notice of Meeting (PDF)
• March 12, 2003 Agenda (PDF) (Word)
• March 12, 2003 Committee Members Roster (PDF) (Word)
• March 12, 2003 Participants Roster (PDF) (Word)
• March 12, 2003 Questions (PDF) (Word)
• March 12, 2003 Briefing Information
• March 12, 2003 Slides
• March 12, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 13, 2003 Agenda (PDF) (Word)
• March 13, 2003 Briefing Information
• March 13, 2003 Slides
• March 13, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Psychopharmacologic Drugs Advisory Committee

Executive Secretary: Anuja M. Patel, MPH (HFD-21), (301) 827-7001

June 16, 2003

• Notice of Meeting (PDF)
• June 16, 2003 Briefing Information
• June 16, 2003 Final Agenda (PDF) (Word)
• June 16, 2003 Slides
• June 16, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• June 16, 2003 Minutes (PDF) (Word)

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Pulmonary-Allergy Drug Advisory Committee

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

September 5, 2003

• Notice of Meeting (PDF)
• September 5, 2003 Draft Agenda (PDF) (Word)
• September 5, 2003 Roster (PDF) (Word)
• September 5, 2003 Draft Questions (PDF) (Word)
• September 5, 2003 Briefing Information
• September 5, 2003 Slides
• September 5, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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May 15, 2003

• Notice of Meeting (PDF)
• May 15, 2003 Draft Questions (PDF) (Word)
• May 15, 2003 Briefing Information
• May 15, 2003 Slides
• May 15, 2003 Transcript (PDF) (Word)
  • May 15, 2003 Concordance Index (PDF)

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Reproductive Health Drugs, Advisory Committee for

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

December 16, 2003 Joint meeting with Nonprescription Drugs Advisory Committee

December 15, 2003

September 29-30, 2003

• Notice of Meeting (PDF)
• September 29, 2003 Final Agenda (PDF) (Word)
• September 30, 2003 Final Agenda (PDF) (Word)
• September 29, 2003 Final Questions (PDF) (Word)
• September 29, 2003 Briefing Information
• September 29, 2003 Slides
• September 29, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 30, 2003 Briefing Information
• September 30, 2003 Slides
• September 30, 2003 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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