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CDER 2006 Meeting Documents


Anesthetic and Life Support Drugs Advisory Committee

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

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Anti-Infective Drugs Advisory Committee

Executive Secretary: LT Sohail Mosaddegh, Pharm.D., R.Ph., (HFD-21), (301) 827-7001

December 14-15, 2006 Joint with Drug Safety and Risk Management Advisory Committee

  • Notice of Meeting (txt) (pdf)
  • Notice of Meeting, amended notice ( htm) (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Final Agenda (pdf)
  • Briefing Information (htm)
  • Roster (pdf)
  • Final Roster (pdf)
  • Questions (pdf)
  • Slides for December 14, 2006 (htm)
  • Slides for December 15, 2006 (htm)
  • Transcript for December 14, 2006 (Part 1) (Part 2) (Part 3) (Part 4)
  • Transcript for December 15, 2006 (Part 1) (Part 2) (Part 3) (Part 4) (Part 5)
  • Summary Minutes (pdf)

September 11-12, 2006

March 6, 2006

  • Notice of Meeting (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Questions (htm) (ppt)
  • Ttranscript (pdf)
  • Summary of Minutes (pdf)
  • Agenda (pdf)
  • Roster (pdf)

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Antiviral Drugs Advisory Committee

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

October 19-20, 2006

  • Notice of Meeting (pdf) (htm)
  • Nature and Basis Statements of Conflict(s) of Interest for October 19-20, 2006 Meeting (htm)
  • Draft Agenda for October 19, 2006 Meeting (pdf)
  • Draft Agenda for October 20, 2006 Meeting (pdf)
  • Final Agenda for October 19-20, 2006 Meeting (pdf)
  • Roster for October 19-20, 2006 Meeting (pdf)
  • Member Roster for October 19-20, 2006 Meeting (pdf)
  • Consultants & Guests Roster for October 19-20, 2006 Meeting (pdf)
  • Briefing Information (htm)
  • Questions (ppt) (htm)
  • Slides (htm)
  • Transcript for October 19, 2006 Meeting (index) (Vol. I)
  • Transcript for October 20, 2006 Meeting (index) (Vol. II)
  • Summary Minutes (pdf)

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Arthritis Drug Advisory Committee

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

November 29, 2006

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Cardiovascular & Renal Drugs Advisory Committee

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

September 21, 2006

April 25-26, 2006

  • Notice of Meeting (htm) (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Roster for April 25, 2006 Meeting (pdf)
  • Roster for April 26, 2006 Morning Session (pdf)
  • Roster for April 26, 2006 Afternoon Session (pdf)
  • Agenda for April 25, 2006 Meeting (pdf)
  • Agenda for Morning of the April 26, 2006 Meeting (pdf)
  • Agenda for Afternoon of the April 26, 2006 Meeting (pdf)
  • Briefing Information for April 25, 2006 Meeting (htm)
  • Briefing Information for April 26, 2006 Meeting (htm)
  • Questions for April 25, 2006 Meeting (pdf)
  • Draft Questions to the Committee - Draft Guidance for Industry Session for April 26, 2006 Meeting (pdf)
  • Draft Questions to the Committee - PHARM Study Session for April 26, 2006 Meeting (pdf)
  • Final Questions to the Committee - Draft Guidance for Industry Session for April 26, 2006 Meeting (pdf)
  • Final Questions to the Committee - PHARM Study Session for April 26, 2006 Meeting (pdf)
  • Slides for April 25, 2006 Meeting (htm)
  • Slides for April 26, 2006 Meeting (htm)
  • Slides of the Open Public Hearing Speakers (htm)
  • Minutes for April 25, 2006 Meeting (pdf)
  • Minutes for Morning of April 26, 2006 Meeting (pdf)
  • Minutes for Afternoon of April 26, 2006 Meeting (pdf)
  • Transcript for April 25, 2006 meeting (pdf)
  • Transcript for the morning session of the April 26, 2006 meeting (pdf)
  • Transcript for the afternoon session of the April 26, 2006 meeting (pdf)

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Dermatologic and Ophthalmic Drugs Advisory Committee

Executive Secretary: LT Sohail Mosaddeht, Pharm.D., R.Ph., (HFD-21), (301) 827-7001

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Drug Safety and Risk Management Advisory Committee

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

December 14-15, 2006 Joint with Anti-Infective Drugs Advisory Committee

  • Notice of Meeting (txt) (pdf)
  • Notice of Meeting, amended notice ( htm) (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Final Agenda (pdf)
  • Briefing Information (htm)
  • Roster (pdf)
  • Final Roster (pdf)
  • Questions (pdf)
  • Slides for December 14, 2006 (htm)
  • Slides for December 15, 2006 (htm)
  • Transcript for December 14, 2006 (Part 1) (Part 2) (Part 3) (Part 4)
  • Transcript for December 15, 2006 (Part 1) (Part 2) (Part 3) (Part 4) (Part 5)
  • Summary Minutes (pdf)

February 9 - 10, 2006

  • Notice of Meeting (pdf)
  • Committee Roster (pdf)
  • Participants Roster (pdf)
  • Final Agenda (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Briefing Information (htm)
  • Questions (pdf)
  • February 9, 2006 Slides (html)
  • Minutes (pdf)
  • February 9, 2006 Transcripts (pdf)
  • February 9, 2006 Errata to Transcripts (pdf)
  • February 10, 2006 Participants Roster (pdf)
  • February 10, 2006 Slides (html)
  • February 10, 2006 Transcripts (pdf)

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Endocrinologic and Metabolic Drugs Advisory Committee

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

October 4, 2006 Meeting with Pharmaceutical Science Advisory Committee

January 23, 2006 Joint Meeting with Nonprescription Drugs Advisory Committee

  • Notice of Meeting (pdf) (htm)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Minutes for January 23, 2006 (pdf)
  • Transcript (pdf)
  • Roster Endocrinologic and Metabolic Drugs Advisory Committee (pdf)
  • Roster Nonprescription Drugs Advisory Committee (pdf)
  • Agenda (pdf)
  • Questions (pdf)

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Gastrointestinal Drugs Advisory Committee

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

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Nonprescription Drugs Advisory Committee

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

Meeting on September 25, 2006

  • Notice of Meeting (pdf ) (htm )
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Draft Agenda (pdf)
  • Final Agenda (pdf )
  • Roster (pdf)
  • Questions (pdf) (ppt) (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript (pdf)

January 24, 2006 Joint Meeting with Pulmonary-Allergy Drugs Advisory Committee

  • Notice of Meeting (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Transcript (pdf)
  • Minutes for January 24, 2006 (pdf)
  • Roster for Nonprescription Drugs Advisory Committee (pdf)
  • Roster for Pulmonary-Allergy Drugs Advisory Committee (pdf)
  • Final Agenda (pdf)
  • Questions (pdf)

January 23, 2006 Joint Meeting with Endocrinologic and Metabolic Drugs Advisory Committee

  • Notice of Meeting (htm)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Minutes for January 23, 2006 (pdf)
  • Transcript (pdf)
  • Roster Endocrinologic and Metabolic Drugs Advisory Committee (pdf)
  • Roster Nonprescription Drugs Advisory Committee (pdf)
  • Agenda (pdf)
  • Questions (pdf)

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Oncologic Drugs Advisory Committee

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

December 6, 2006 Pediatric Oncology Subcommittee Meeting

September 6 - 7, 2006

  • Notice of Meeting (pdf) (htm)
  • Nature and Basis Statements of Conflict(s) of Interest for September 6, 2006 Meeting (htm)
  • Nature and Basis Statements of Conflict(s) of Interest for September 7, 2006 Meeting (htm)
  • Roster for Morning Session of September 6, 2006 Meeting (pdf)
  • Roster for Afternoon Session of September 6, 2006 Meeting (pdf)
  • Roster for September 7, 2006 Meeting (pdf)
  • Briefing Information for September 6, 2006 Meeting (htm)
  • Briefing Information for September 7, 2006 Meeting (htm)
  • Questions for Morning Session of September 6, 2006 Meeting (ppt) (htm)
  • Questions for Morning Session of September 6, 2006 Meeting (ppt) (htm)
  • Questions for Morning Session of September 6, 2006 Meeting (ppt) (htm)
  • Slides for September 6-7, 2006 Meeting (htm)
  • Transcript for Morning Session for the September 6, 2006 Meeting (pdf)
  • Transcript for Afternoon Session for the September 6, 2006 Meeting (pdf)
  • Transcript for the September 7, 2006 Meeting (pdf)
  • Summary Minutes for Genasense for the September 6, 2006 meeting (pdf)
  • Summary Minutes for Fragmin (dalteparin sodium) Injection for the September 6, 2006 meeting (pdf)
  • Summary Minutes for the September 7, 2006 meeting (pdf)
  • Final Agenda (pdf)

June 2, 2006 Meeting

  • Notice of Meeting (pdf) (htm)
  • Draft Agenda (pdf)
  • Final Agenda (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Roster (pdf)
  • Guests & Consultants (pdf)
  • Open Public Hearing Speakers (ppt) (htm)
  • Briefing Information (htm)
  • Questions (ppt) (htm)
  • Slides (htm)
  • Transcript (pdf)

March 14, 2006 Pediatric Oncology Subcommittee Meeting

  • Notice of Meeting (pdf) (htm)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Agenda (pdf)
  • Roster (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript (pdf)
  • Questions (pdf)

March 13, 2006 Meeting

  • Notice of Meeting (pdf) (htm)
  • Amended Notice of Meeting (htm)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Center Roster (pdf)
  • Consultant Roster (pdf)
  • Final Agenda (pdf)
  • Briefing Information (htm)
  • Slides (htm)
  • Transcript (pdf)
  • Minutes (pdf)
  • Questions for AM Session (pdf)
  • Questions for PM Session (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

September 6-7, 2006 with Dental Devices Panel

May 17, 2006 Meeting

  • Notice of Meeting (htm) (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Roster (pdf)
  • Agenda (pdf)
  • Final Agenda (pdf)
  • Briefing Information (htm)
  • Minutes (pdf)
  • Slides (htm)
  • Questions (ppt) (htm)
  • Transcripts (pdf)

March 7-8, 2006 Meeting

  • Notice of Meeting (htm) (pdf)
  • Amended Notice of Meeting ( htm) (pdf)
  • Final Agenda (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Briefing Information (htm)
  • Questions (pdf) (ppt)
  • Slides (htm)
  • Minutes (pdf)
  • Transcript for March 7, 2006 (pdf)
  • Transcript for March 8, 2006 (pdf)
  • Roster (pdf)

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Pharmaceutical Science, Advisory Committee for

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

October 18-19, 2006 Clinical Pharmacology Subcommittee Meeting

  • Notice of meeting (txt) (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest (htm)
  • Agenda (pdf)
  • Final Agenda for October 18, 2006 Meeting (pdf)
  • Final Agenda for October 19, 2006 Meeting (pdf)
  • Questions (pdf)
  • Final Questions for October 18-19, 2006 Meeting (htm)
  • Final Questions (htm)
  • Briefing Information (htm)
  • Minutes for October 18, 2006 Meeting (pdf)
  • Minutes for October 19, 2006 Meeting (pdf)
  • Slides for October 18, 2006 Meeting (htm)
  • Slides for October 19, 2006 Meeting (htm)
  • Transcript for October 18, 2006 Meeting (Part 1.pdf) (Part 2.pdf) (Part 3.pdf) (Part 4.pdf)
  • Transcript for October 19, 2006 Meeting (pdf)
  • Roster (pdf)

October 5-6, 2006 Meeting

  • Notice of Meeting (htm) (pdf)
  • Nature and Basis Statements of Conflict(s) of Interest for Otober 5-6, 2006 Meeting (htm)
  • Agenda for October 5, 2006 Meeting (pdf)
  • Agenda for October 6, 2006 Meeting (pdf)
  • Briefing Information (htm)
  • Questions (htm)
  • Slides for October 5, 2006 Meeting (htm)
  • Slides for October 6, 2006 Meeting (htm)
  • Minutes for October 5, 2006 Meeting (pdf)
  • Minutes for October 6, 2006 Meeting (pdf)
  • Transcript for October 5, 2006 (Part 1.pdf) (Part 2.pdf) (Part 3.pdf) (Part 4.pdf)
  • Transcript for October 6, 2006 (Part 1.pdf) (Part 2.pdf) (Part 3.pdf)
  • Roster (pdf)

October 4, 2006 Meeting with Endocrinologic and Metabolic Drugs Advisory Committee

April 18-19, 2006 Manufacturing Subcommittee Meeting

  • Notice of Meeting [ htm] [ pdf]
  • Notice of Cancellation of Meeting [ htm] [ pdf]

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Psychopharmacologic Drugs Advisory Committee

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

December 13, 2006

  • Notice of Meeting (txt) (pdf)
  • Nature and Basis Statements of Conflicts(s) of Interest (htm)
  • Briefing Information (pdf)
  • Roster (pdf)
  • Slides (htm)
  • Open Public Hearing Speakers List (pdf) (htm)
  • Transcript (Part 1.pdf) (Part 2.pdf)
  • Agenda (pdf)
  • Questions (pdf)
  • Summary Minutes (pdf)

September 7-8, 2006 Meeting

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

March 23, 2006 Meeting

  • Notice of Meeting (htm ) (pdf )
  • Nature and Basis Statements of Conflicts(s) of Interest (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Transcripts (htm) (pdf)
  • Agenda (pdf)
  • Questions (pdf)
  • Roster (pdf)
  • Summary Minutes (pdf)

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Pulmonary-Allergy Drugs Advisory Committee

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

January 24, 2006 Joint Meeting with Nonprescription Drugs Advisory Committee

  • Notice of Meeting (pdf) (htm)
  • Nature and Basis Statements of Conflicts(s) of Interest (htm)
  • Briefing Information (htm)
  • Slides (htm)
  • Transcript (pdf)
  • Minutes for January 24, 2006 (pdf)
  • Roster for Nonprescription Drugs Advisory Committee (pdf)
  • Roster for Pulmonary-Allergy Drugs Advisory Committee (pdf)
  • Final Agenda (pdf)
  • Questions (pdf)

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Reproductive Health Drugs, Advisory Committee for

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

August 29, 2006

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Page updated: March 27, 2007