CDER 2002 Meeting Documents

Anesthetic and Life Support Drugs Advisory Committee

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

May 16, 2002

• Notice of Meeting (PDF)
• May 16, 2002 Draft Agenda  (PDF)  (Word)
• May 16, 2002 Roster (pdf)
• May 16, 2002 Questions  (PDF)  (Word)
• May 16, 2002 Slides
• May 16, 2002 Briefing Information
• May 16, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)  

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January 30-31, 2002

• Notice of Meeting (PDF)
• January 30, 202 Draft Agenda (PDF) (Word)
• January 30, 2002 Committee Roster (PDF) (Word)
• January 30, 2002 Questions (PDF) (HTM)
• January 30, 2002 Open Public Hearing  (PDF) (Word)
• January 30, 2002 Briefing Information
• January 30, 2002 Slides
• Docket Number 01N-0256
• January 30, 2002 Transcript (PDF) (Word) 
  • Concordance Index 
• January 30, 2002 Minutes (PDF)  (Word)
• January 31, 2002 Draft Agenda (PDF)  (Word)
• January 31, 2002 Slides
• January 31, 2002 Transcript  (PDF) (Word)
  • Concordance Index (PDF) 

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Anti-Infective Drugs Advisory Committee

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

July 10-11, 2002

• Notice of Meeting   (PDF) 
• July 10, 2002 Final Agenda  (PDF) (Word)
• July 10, 2002 Questions   (PDF) (Word)
• July 10, 2002 Committee Roster (PDF) (Word)  
• July 10, 2002 Consultants Roster (PDF) (Word) 
• July 10, 2002 Briefing Information 
• July 10, 2002 Slides 
• July 10, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• July 11, 2002 Final Agenda  (PDF)  (Word)
• July 11, 2002 Questions (PDF) (Word)
• July 11, 2002 Roster Consultants  (PDF) (Word)
• July 11, 2002 Briefing Information
• July 11, 2002 Slides
• July 11, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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June 11, 2002 Pediatric Subcommittee

• Notice of Meeting  (PDF)
• June 11, 2002 Agenda  (PDF) (Word)
• June 11, 2002 Roster (PDF)
• June 11, 2002 Questions (PDF) (Word)
• June 11, 2002 Briefing Information
• June 11, 2002 Slides
• June 11, 2002 Transcript  
  • Pages 1-100
  • Pages 101-200
  • Pages 201-300
  • Pages 301-400
  • Pages 401-433
  • Concordance Index (PDF)
• Draft Minutes (PDF)

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February 19-20, 2002

• Notice of Meeting   (PDF)
• February 19, 2002 Agenda (PDF) (Word)
• February 19, 2002 Questions (PDF) (Word)
• February 19, 2002 Committee Roster (PDF) (Word)
• February 19, 2002 Guests Roster (PDF) (Word)
• February 19, 2002 Briefing Information
• February 19, 2002 Slides
• February 19, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• February 20, 2002 Agenda (PDF) (Word)
• February 20, 2002 Questions (PDF) (PDF)
• February 20, 2002 Committee Roster  (PDF) (Word)
• February 20, 2002 Guests Roster (PDF) (Word)
• February 20, 2002 Briefing Information
• February 20, 2002 Slides
• February 20, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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Antiviral Drugs Advisory Committee

Executive Secretary: Tara P. Turner, Pharm.D. (HFD-21), (301) 927-7001

November 14, 2002

• Notice of Meeting (PDF)
• November 14, 2002 Final Agenda (PDF) (Word)
• November 14, 2002 Committee Roster (PDF) (Word) (HTM)
• November 14, 2002 Participants Roster (PDF) (Word) (HTM)
• November 14, 2002 Questions (PDF) (Word)
• November 14, 2002 Briefing Information
• November 14, 2002 Slides
• November 14, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• November 14, 2002 Draft Minutes (PDF)

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August 6-7, 2002

• Notice of Meeting (PDF)
• August 6, 2002 Final Agenda (PDF) (Word)
• August 6, 2002 Committee Roster (PDF) (Word)
• August 6, 2002 Guests/Consultants Roster  ( PDF) (Word)
• August 6, 2002 Questions (PDF) (Word)
• August 6, 2002 Briefing Information
• August 6, 2002 Slides
• August 6, 2002 Transcript  (PDF) (Word)
  • Concordance Index  
• August 6, 2002 Draft Minutes (PDF)
• August 7, 2002 Final Agenda ( PDF) (Word)
• August 7, 2002 Committee Roster  ( PDF) (Word)
• August 7, 2002 Guests/Consultants Roster ( PDF) (Word)
• August 7, 2002 Questions  (PDF) (Word)  
• August 7, 2002 Briefing Information
• August 7, 2002 Slides
• August 7, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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March 19, 2002

• Notice of Meeting ( PDF)
• March 19, 2002 Agenda (PDF) (Word)
• March 19, 2002 Roster Committee (PDF) (Word)
• March 19, 2002 Guests (PDF) (Word)
• March 19, 2002 Questions  (PDF) (Word)
• March 19, 2002 Briefing Information
• March 19, 2002 Slides
• March 19, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 19, 2002 Draft Minutes (PDF)

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January 24, 2002 Immunosuppressive Subcommittee

• Notice of Meeting (PDF)
• January 24, 2002 Final Agenda (PDF) (Word)
• January 24, 2002 Draft Agenda (PDF) (Word)
• January 24, 2002 Final Questions (PDF)  (Word
• January 24, 2002 Draft Questions (PDF)  (Word)
• January 24, 2002 Roster (PDF) (Word)
• January 24, 2002 Briefing Information
• January 24, 2002 Slides
• January 24, 2002 Transcript (Word)
• (PDF) 
• Concordance Index (PDF)

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Arthritis Advisory Committee

Executive Secretary: Kathleen Reedy RDH, MS (HFD-21), (301) 287-7001

July 29-30, 2002

• Notice of Meeting (PDF)
• July 29, 2002 Draft Agenda  (PDF) (Word) 
• July 29, 2002 Committee Roster  (PDF) (Word)
• July 29, 2002 Consultant-Guest Roster (PDF) (Word) 
• July 29, 2002 Final Consultant-Guest Roster  doc  
• July 29, 2002 Questions  (PDF) (Word) 
• July 29, 2002 Briefing Information
• July 29, 2002 Slides
• July 29, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-300 (PDF)
  • Pages 301-354 (PDF)
  • Concordance Index (PDF)
• July 30, 2002 Questions (PDF) (Word)
• July 30, 2002 Slides
• July 30, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-245 (PDF) 
  • Concordance Index (PDF) 

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Cardiovascular and Renal Drugs Advisory Committee

Executive Secretary: Igor Cerny, Pharm.D. (HFD-21), (301) 827-7001

July 18-19, 2002

• Notice of Meeting (PDF version not available)
• July 18, 2002 Draft Agenda (PDF) (Word)
• July 18, 2002 Final Agenda (Word) (PDF
• July 18, 2002 Roster (PDF) (Word)
• July 18, 2002 Questions-Candesartan (PDF) (Word)
• July 18, 2002 Questions-Prava-ASA (PDF) (Word)
• July 18, 2002 Briefing Information-Morning
• July 18, 2002 Briefing Information-Afternoon 
• July 18, 2002 Slides
• July 18, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-292 (PDF)
  • Concordance Index (PDF) 
• July 19, 2002 Agenda (PDF) (Word)
• July 19, 2002 Questions-Omapatrilat (PDF) (Word)
• July 19, 2002 Briefing Information
• July 19, 2002 Slides
• July 19, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-294 (PDF)
  • Concordance Index (PDF)
• July 18-19, 2002 Minutes (PDF)

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April 12, 2002

• Notice of Meeting (PDF)
• April 12, 2002 Agenda (PDF) (Word)
• April 12, 2002 Questions (PDF) (Word)
• April 12, 2002 Committee Roster (PDF) (Word)
• April 12, 2002 Consultants Roster (PDF) (Word)
• April 12, 2002 Briefing Information
• April 12, 2002 Slides
• April 12, 2002, Transcript (PDF) (Word)
  • Concordance Index (PDF) 
• April 12, 2002 Minutes ( PDF)

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January 17-18, 2002

• Notice of Meeting (PDF)
• January 17, 2002 Draft Agenda (PDF) (Word)
• January 17, 2002 Roster (PDF) (Word)
• January 17, 2002 Questions (PDF) (HTM)
• January 17, 2002 Briefing Information
• January 17, 2002 Slides
• January 17, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-300 (PDF)
  • Pages 301-342 (PDF)
• January 18, 2002 Questions (PDF) (Word)
• January 18, 2002 Briefing Information
• January 18, 2002 Slides
• January 18, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-244 (PDF)
• January 17-18, 2002 Draft Minutes (PDF)

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Dermatologic and Ophthalmic Drugs Advisory Committee

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

November 4-5, 2002

• Notice of Meeting (PDF)
• November 4-5, 2002 Final Agenda  (PDF) (Word)
• November 4, 2002 Draft Agenda  (PDF)  )Word)
• November 4-5, 2002 Committee Roster  (PDF) (Word)
• November 4-5, 2002 Consultant/Guests Roster (PDF) (Word)
• November 4-5, 2002 Questions (PDF) (Word)
• November 4, 2002 Briefing Information
• November 4-5, 2002 Slides
• November 4, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• November 5, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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May 23, 2002

• Notice of Meeting (PDF)
• May 23, 2002 Draft Agenda (PDF) (Word)
• May 23, 2002 Final Agenda (PDF) (Word)
• May 23, 2002 Committee Roster (PDF) (Word)
• May 23, 2002 Consultants Roster (PDF) (Word)
• May 23, 2002 Draft Questions
• May 23, 2002 Final Questions (PDF) (Word)
• May 23, 2002 Briefing Information
• May 23, 2002 Open Public Hearing 
• May 23, 2002 Slides
• May 23, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-300 (PDF)
  • Pages 201-300 (PDF)
• May 23, 2002 Minutes (PDF) (Word)

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Drug Safety and Risk Management Advisory Committee

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

July 17, 2002

• Notice of Meeting (PDF)
• July 17, 2002 Agenda (pdf) (Word)
• July 17, 2002 Roster (PDF) (Word)
• July 17, 2002 Open Public Hearing Speakers (PDF) (Word)
• July 17, 2002 Questions (PDF) (Word)
• July 17, 2002 Briefing Information
• July 17, 2002 Slides
• Open Public Hearing
• July 17, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-298 (PDF)
  • Concordance Index (PDF)

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Endocrinologic and Metabolic Drugs Advisory Committee

Executive Secretary: Kathleen Reedy, RDH, MS (HFD-21) (301) 827-7001

September 25-27, 2002  [September 26-27, 2002 Postponed (Notice of Amendment  (PDF)]

• Notice of Meeting (PDF)
• September 25, 2002 Draft Agenda (PDF) (Word)
• September 25, 2002, Final Agenda (PDF) (Word)
• September 25, 2002 Draft Guest Roster (PDF) (Word)
• September 25, 2002 Final Guest Roster (PDF) (Word)
• September 25, 2002 Open Hearing Speakers (PDF) (Word)
• September 25, 2002 Draft Questions (PDF) (Word)
• September 25, 2002 Final Questions (PDF) (Word)
• September 25, 2002 Briefing Information
• September 25, 2002 Slides
• September 25, 2002 Transcript (Word)
  • Page 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-300 (PDF)
  • Pages 301-400 (PDF)
  • Pages 401-431 (PDF)
  • Concordance Index (PDF)
• September 26, 2002 Draft Agenda (PDF) (Word)
• September 27, 2002 Draft Agenda (PDF) (Word)

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Gastrointestinal Drugs Advisory Committee

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

June 21, 2002  Joint Meeting with the Nonprescription Drugs Advisor y Committee

• Notice of Meeting (PDF)
• June 21, 2002 Agenda (PDF) (Word)
• June 21, 2002 Final Questions (PDF) (Word)
• June 21, 2002 Nonprescription Drugs Roster (PDF) (Word)
• June 21, 2002 Gastrointestinal Drugs Roster (PDF) (Word)
• June 21, 2002 Consultants Roster (PDF) (Word)
• June 21, 2002 Briefing Information
• June 21, 2002 Slides
• June 21, 2002 Open Public Hearing
• June 21, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-319 (PDF)
  • Concordance Index (PDF) 
• June 21, 2002 Minutes (PDF) (Word)

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April 23, 2002 Joint Meeting with the Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science

• Notice of Meeting (PDF)
• April 23, 2002 Agenda (PDF)
• April 23, 2002 Draft Open Public Hearing Agenda (PDF) (Word)
• Final Questions (PDF)
• Aril 23, 2002 Draft Questions (PDF) (Word)
• April 23, 2002 Gastrointestinal Committee Roster (PDF) (Word)
• April 23, 2002 Pharmaceutical Science Committee Roster (PDF) (Word)
• April 23, 2002 Drug Safety Risk Management Subcommittee Roster (PDF) (Word)
• April 23, 2002 Briefing Information
• April 23, 2002 Open Public Hearing Materials
• April 23, 2002 Slides
• April 23, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• April 23, 2002 Minutes
• April 23, 2002 Questions (PDF)

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March 19, 2002

• Notice of Meeting (PDF)
• March 19, 2002 Draft Agenda (PDF) (Word)
• March 19, 2002 Final Agenda (PDF) (Word) (HTM)
• March 19, 2002 Questions (PDF) (Word)
• March 19, 2002 Roster (PDF) (Word)
• March 19, 2002 Briefing Information
• March 19, 2002 Slides
• March 19, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• March 19, 2002 Minutes (PDF) (Word)

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Medical Imaging Drugs Advisory Committee

Executive Secretary: Jayne Peterson, R,Ph,, J.D. (HFD-21), (301) 827-7001

November 18-19, 2002 Joint Meeting with the Peripheral and Central Nervous System Drugs Advisory Committee

• Notice of Meeting (PDF)
• Amendment of Notice - Cancels that portion of the meeting scheduled for 11/19/02 (txt) (pdf)
• November 18, 2002 Draft Agenda (PDF) (HTM)
• November 18, 2002 Final Agenda (PDF) (HTM)
• November 18, 2002 Consultants/Guests Roster (PDF) (HTM)
• November 18-19, 2002 Committee Roster (PDF) (HTM)
• November 18, 2002 Briefing Information (HTM)
• November 18, 2002 Questions (pdf) (htm)
• November 18, 2002 Minutes (pdf) (htm)
• November 18, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF

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Nonprescription Drugs Advisory Committee

Executive Secretary: Sandra Titus, PhD (HFD-21), (301) 827-7001

September 19-20, 2002

• Notice of Meeting (PDF)
• September 19, 2002 Draft Agenda (PDF) (Word)
• September 19, 2002 Second Draft Agenda (PDF) (Word)
• September 19, 2002 Final Agenda (PDF) (Word)
• September 19, 2002 Discussion Points (PDF) (Word)
• September 19, 2002 Meeting Information (PDF) (Word)
• September 19, 2002 Committee Members Roster (PDF) (Word)
• September 19, 2002 Consultants Members Roster (PDF) (Word)
• September 19, 2002 Briefing Information
• September 19, 2002 Slides
• September 19, 2002 Open Public Hearing
• September 19, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 20, 2002 Second Draft Agenda (PDF) (Word)
• September 20, 2002 Final Agenda (PDF) (Word)
• September 20, 2002 Discussion Points (PDF) (Word)
• September 20, 2002 Briefing Information
• September 20, 2002 Slides
• September 20, 2002 Open Public Hearing
• September 20, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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June 21, 2002 Joint Meeting with the Gastrointestinal Drugs Advisory Committee

• Notice of Meeting (PDF)
• June 21, 2002 Agenda (PDF) (Word)
• June 21, 2002 Final Questions (PDF) (Word)
• June 21, 2002 Nonprescription Drugs Roster (PDF) (Word)
• June 21, 2002 Gastrointestinal Drugs Roster (PDF) (Word)
• June 21, 2002 Consultants Roster (PDF) (Word)
• June 21, 2002 Briefing Information
• June 21, 2002 Slides
• June 21, 2002 Open Public Hearing
• June 21, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-319 (PDF)
  • Concordance Index (PDF) 
• June 21, 2002 Minutes (PDF) (Word

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April 22, 2002

• Notice of Meeting (PDF) (HTM)
• April 22, 2002 Revised 04/19/02 Draft Agenda (PDF) (Word) (HTM)
• April 22, 2002 Draft Agenda (PDF) (Word) (HTM)
• April 22, 2002 Questions  (PDF) (Word) (HTM)
• April 22, 2002 Committee Roster (PDF) (Word) (HTM)
• April 22, 2002 Consultants Roster (PDF) (Word)
• April 22, 2002 Briefing Information
• April 22, 2002 Slides
• April 22, 2002 Transcript (PDF) (Word) (HTM)
  • Concordance Index (PDF)
• April 22, 2002 Minutes (PDF) (Word)

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Oncologic Drugs Advisory Committee

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

December 17-18, 2002

• Notice of Meeting (PDF)
• December 17-18, 2002 Draft Agenda (PDF) (Word)
• December 17, 2002 Final Agenda (PDF) (Word)
• December 17-18, 2002 Committee Roster (PDF) (Word)
• Decmeber 17, 2002 Consultants/Guests Roster (PDF) (Word)
• December 17, 2002 Briefing Information
• December 17, 2002 Slides
• December 17, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• December 18, 2002 Open Public Hearing Speakers (PDF) (Word)
• December 18, 2002 Briefing Information
• Decmeber 18, 2002 Slides
• December 18, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• December 17-18, 2002 Draft Minutes (pdf)

October 17, 2002 Pediatric Oncology Subcommittee

• Notice of Meeting  (PDF)
• October 17, 2002 Agenda  (PDF)  (Word)
• October 17, 2002 Committee Roster  (PDF) ( Word)
• October 17, 2002 Consultants Roster  (PDF)  (Word)
• October 17, 2002 Questions  PDF) (Word)
• October 17, 2002 Briefing Information
• October 17, 2002 Slides
• October 17, 2002 Transcript (PDF) (Word)
• Concordance Index (PDF)
• (October 17, 2002 Summary Minutes) (PDF) (Word)

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September 24, 2002

• Notice of Meeting (PDF)
• September 24, 2002 Draft Agenda (PDF) (Word)
• September 24, 2002 Final Agenda (PDF) (Word)
• September 24, 2002 Committee Roster (PDF) (Word)
• September 24, 2002 Consultants Roster (PDF) (Word)
• September 24, 2002 Questions (PDF) (Word)
• September 24, 2002 Briefing Information
• September 24, 2002 Slides
• September 24, 2002 Transcript (PDF) (Word)
  • Concordance Index
• September 24, 2002 Draft Minutes (PDF)

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February 27, 2002

• Notice of Meeting (PDF)
• February 27, 2002 Draft Agenda (PDF) (Word)
• February 27, 2002 Committee Roster (PDF)
• February 27, 2002 Briefing Information
• February 27, 2002 Slides
• February 27, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF) 

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January 31, 2002

• Notice of Meeting (PDF)
• January 31, 2002 Final Agenda (PDF) (Word)
• January 31, 2002 Draft Agenda (PDF) (Word)
• January 31, 2002 Questions (PDF) (Word)
• January 31, 2002 Committee Roster (PDF) (Word)
• January 31, 2002 Guests Roster (PDF) (Word)
• January 31, 2002 briefing Information
• January 31, 2002 Slides
• January 31, 2002 Transcript  (PDF) (Word)
  • Concordance Index (PDF)
• January 31, 2002 Draft Minutes (PDF)

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Peripheral and Central Nervous System Drugs Advisory Committee

Executive Secretary: Sandra Titus, PhD (HFD-21), (301) 827-7001

November 18-19, 2002 Joint Meeting with Medical Imaging Drugs Advisory Committee

• Notice of Meeting (PDF)
• Amendment of Notice - Cancels that portion of the meeting scheduled for 11/19/02 (txt) (pdf)
• November 18, 2002 Draft Agenda (PDF) (Word)
• November 18, 2002 Final Agenda (PDF) (Word)
• November 18, 2002 Consultants/Guests Roster (PDF) (Word)
• November 18-19, 2002 Committee Roster (PDF) (Word)
• November 18, 2002 Updated Committee Roster (PDF) (Word)
• November 18, 2002 Questions (pdf) (htm)
• November 18, 2002 Briefing Information
• November 18, 2002 Slides
• November 18, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• November 18, 2002 Summary of Minutes (PDF) (Word)

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Pharmaceutical Science Advisory Committee

Executive Secretary: Kathleen Reedy, RDH, MS (HFD-21), (301) 827-7001

October 23, 2002 Process Analytical Technology Subcommittee

• Notice of Meeting (PDF)
• October 23, 2002 Draft Agenda (PDF) (Word)
• October 23,, 2002 Participants Roster (PDF) (Word)
• October 23, 2002 Committee Roster (PDF)
• October 23, 2002 Briefing Information
• October 23, 2002 Slides
• October 23, 2002 Transcript (PDF) (Word)
  • Concordance Index

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October 23, 2002 Clinical Pharmacology Subcommittee

• Notice of Meeting (PDF)
• October 23, 2002 Draft Agenda  (PDF) (Word)
• October 23, 2002 Final Agenda  (PDF) (Word)
• October 23, 2002 Subcommittee Roster (PDF) (Word)
• October 23, 2002 Participants Roster (PDF) (Word)
• October 23, 2002 Briefing Information
• October 23, 2002 Slides
• October 23, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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October 21-22, 2002

• Notice of Meeting  (PDF)
• October 21, 2002 Agenda  (PDF)  (Word)
• October 21, 2002 Committee Roster  (PDF) (Word)
• October 21, 2002 Participants Roster (PDF) (Word)
• October 21, 2002 Briefing Information
• October 21, 2002 Slides
• October 21, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• October 22, 2002 Draft Agenda  (PDF) (Word)
• October 22, 2002 Slides
• October 22, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)

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September 9-10, 2002 Nonclinical Studies Subcommittee

• Notice of Meeting (PDF)
• September 9-10, 2002 Agenda (PDF) (Word)
• Committee Roster (PDF)
• September 9, 2002 Briefing Information
• September 9, 2002 Slides
• September 9, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 10, 2002 Slides
• September 10, 2002 Transcript (PDF) (Word)
  • Concordance Index

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June 12-13, 2002 Process Analytical Technologies Subcommittee

• Notice of Meeting (PDF)
• June 12, 2002 Proposed Agenda (PDF) (Word)
• June 12, 2002 Final Agenda (PDF) (Word)
• June 12, 2002 Roster (PDF) (Word)
• June 12, 2002 Draft Questions (PDF) (Word)
• June 12, 2002 Final Questions (PDF) (Word)
• June 12, 2002 Briefing Information
• June 12, 2002 Open Public Hearing
• June 12, 2002 Slides
• June 12, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-305 (PDF)
  • Concordance Index (PDF)
• June 12, 2002 Minutes (PDF) (Word)
• June 13, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-206 (PDF)
  • Concordance Index (PDF)

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May 7-8, 2002

• Notice of Meeting (PDF) (HTM)
• May 7, 2002 Agenda (PDF) (Word)
• Committee Roster (PDF)
• May 7, 2002 Questions (PDF) (Word)
• May 7, 2002 Briefing Information 
• May 7, 2002 Transcript (PDF) (Word) (HTM)
• May 8, 2002 Briefing Information
• May 8, 2002 Transcript (PDF) (Word) (HTM)

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April 23, 2002 Joint Meeting of Gastrointestinal Drugs Advisory Committee with the Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science

• Notice of Meeting (PDF)
• April 23, 2002 Agenda (PDF) (Word)
• April 23, 2002 Open Public Hearing Draft Agenda (PDF) (Word)
• April 23, 2002 Final Questions (PDF) (Word)
• April 23, 2002 Draft Questions (PDF) (Word)
• April 23, 2002 Gastrointestinal Committee Roster (PDF) (Word)
• April 23, 2002 Pharmaceutical Science Committee Roster (PDF) (Word)
• April 23, 2002 Drug Safety & Risk Management Subcommittee Roster (PDF) (Word)
• April 23, 2002 Briefing Information
• April 23, 2002 Open Public Hearing Materials

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February 25-26, 2002 Process Analytical Technologies Subcommittee

• Notice of Meeting (PDF)
• February 25, 2002 Revised Agenda (PDF) (Word)
• February 25, 2002 Draft Agenda (PDF) (Word)
• February 25, 2002 Draft Questions (PDF) (Word)
• February 25, 2002 Subcommittee Roster (PDF) (Word)
• February 25, 2002 Working Group 1 (PDF) (Word)
• February 25, 2002 Working Group 2 (PDF) (Word)
• February 25, 2002 Working Group 3 (PDF) (Word)
• February 25, 2002 Working Group 4 (PDF) (Word)
• February 25, 2002 Open Public Speakers (PDF) (Word)
• February 25, 2002 Briefing Information
• February 25, 2002 Slides
• February 25, 2002 Transcript (PDF) (RTF) (Word)
• February 26, 2002 Transcript (PDF) (RTF) (Word)
  • Concordance Index (PDF)

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Psychopharmacologic Drugs Advisory Committee

Executive Secretary: Sandra Titus, PhD (HDF-21). (301) 827-7001

November 4, 2002

• Notice of Meeting (PDF)
• November 4, 2002 Agenda (PDF) (Word)
• November 4, 2002 Committee Roster (PDF)
• November 4, 2002 Questions (PDF) (Word)
• November 4, 2002 Briefing Information
• November 4, 2002 Slides
• November 4, 2002 Minutes (PDF) (Word)
• November 4, 2002 Transcript (Word)
  • Pages 1-98 (PDF)
  • Pages 99-198 (PDF)
  • Pages 199-256 (PDF)
  • Concordance Index (PDF)

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May 10, 2002

• Notice of Meeting (PDF)
• May 10, 2002 Agenda (PDF) (Word)
• May 10, 2002 Final Questions (PDF) (Word)
• May 10, 2002 Draft Questions (PDF) (Word)
• May 10, 2002 Committee Roster (PDF) (Word)
• May 10, 2002 Consultants Roster (PDF) (Word)
• May 10, 2002 Briefing Information
• May 10, 2002 Slides
• May 10, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 201-290 (PDF)
  • Concordance Index (PDF)
• May 10, 2002 Minutes (PDF) (Word)

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Pulmonary/Allergy Drugs Advisory Committee

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

December 20, 2002 Cancelled

• Notice of Meeting (PDF)
• Notice of Cancellation (PDF)
• December 20, 2002 Briefing Information (PDF)

September 6, 2002

• Notice of Meeting (PDF)
• September 6, 2002 Draft Agenda (PDF) (Word)
• September 6, 2002 Final Agenda (PDF) (Word)
• September 6, 2002 Committee/Consultants Roster (PDF) (Word)
• September 6, 2002 Questions (PDF) (Word)
• September 6, 2002 Information Papers (PDF) (Word)
• September 6, 2002 Open Public Hearing Instructions (PDF) (Word)
• September 6, 2002 Briefing Information
• September 6, 2002 Slides
• September 6, 2002 Transcript (PDF) (Word)
  • Concordance Index (PDF)
• September 6, 2002 Minutes (PDF) (Word)

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January 17, 2002

• Notice of Meeting (PDF)
• January 17, 2002 Draft Agenda (PDF) (Word)
• January 17, 2002 Rosters (PDF) (Word)
• January 17, 2002 Questions (PDF) (Word)
• January 17, 2002 Briefing Information
• January 17, 2002 Slides
• January 17, 2002 Transcript (Word)
  • Pages 1-100 (PDF)
  • Pages 101-200 (PDF)
  • Pages 101-200 (PDF)
  • Pages 301-327 (PDF)
  • Concordance Index (PDF)
• January 17, 2002 Minutes (PDF) (Word)

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Reproductive Health Drugs Advisory Committee

Executive Secretary: Jayne Peterson, R.Ph, J.D. (HFD-21), (301) 827-7001

November 12, 2002 Women's Health Initiative Subcommittee [Meeting Postponed]

• Notice of Meeting (PDF) 

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