Posted on November 20, 2009

Cardiovascular and Renal Drugs Advisory Committee

• Richard Mann, M.D. 18 U.S.C. 208 waiver  (PDF - 45KB)
• Richard Mann, M.D. Disclosure Document  (PDF - 30KB)
• Waivers for Conflicts of Interest for the December 7, 2009 Meeting of the Cardiovascular and Renal Drugs Advisory Committee

Posted on November 19, 2009

Peripheral and Central Nervous System Drugs Advisory Committee

• Transcript for the August 11, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 451KB)

Vaccines and Related Biological Products Advisory Committee

• 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

Advisory Committee Calendar

• November 20, 2009: Neurological Devices Advisory Committee Meeting Announcement (Postponed)
• December 15, 2009: Vaccines & Related Biological Products Advisory Committee Meeting Announcement

Posted on November 18, 2009

Peripheral and Central Nervous System Drugs Advisory Committee

• Final Meeting Roster for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 13KB)
• Final Questions for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 9KB)
• Slides for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee
• Final Agenda for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 13KB)
• Minutes for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 76KB)
• Acorda-Backup Presentation-Slides for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 748KB)
• Acorda-Core Presentation-Slides for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 4397KB)
• FDA-Core Presentation-Slides for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 309KB)
• Transcript for the October 14, 2009 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee  (PDF - 1383KB)

Oncologic Drugs Advisory Committee

• Transcript for the October 5, 2009 Meeting of the Oncologic Drugs Advisory Committee - PM Session  (PDF - 223KB)
• Transcript for the October 5, 2009 Meeting of the Oncologic Drugs Advisory Committee - AM Session  (PDF - 251KB)
• Errata to the Transcript for the September 2, 2009 Meeting of the Oncologic Drugs Advisory Committee - AM Session  (PDF - 9KB)

Endocrinologic and Metabolic Drugs Advisory Committee

• 2010 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

Advisory Committee Calendar

• December 17, 2009: Oncologic Drugs Advisory Committee Meeting Announcement
• December 16, 2009: Oncologic Drugs Advisory Committee Meeting Announcement
• January 12-13, 2010: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Posted on November 17, 2009

Drug Safety and Risk Management Advisory Committee

• FDA Briefing Information for the December 8, 2009 Joint Meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees  (PDF - 1919KB)
• Briefing Information for the December 8, 2009 Joint Meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees

Advisory Committee Calendar

• January 25, 2010: National Mammography Quality Assurance Advisory Committee Meeting Announcement
• March 25, 2010: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Posted on November 16, 2009

Pulmonary-Allergy Drugs Advisory Committee

• Draft Questions for the November 20, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 22KB)
• Briefing Information for the November 20, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee
• FDA Briefing Information for the November 20, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 2477KB)
• Draft Roster for the November 20, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 36KB)
• Draft Agenda for the November 20, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 19KB)
• Pharmaxis Briefing Information for the November 20, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 952KB)

Anti-Infective Drugs Advisory Committee

• Briefing Materials for the December 9, 2009 Meeting of the Anti-Infective Drugs Advisory Committee
• FDA Briefing Materials for the December 9, 2009 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 2596KB)

Posted on November 13, 2009

Science Advisory Board to the National Center for Toxicological Research

• November 17-18, 2009 Science Advisory Board to NCTR—Summary of Division Reviews

Pulmonary-Allergy Drugs Advisory Committee

• Draft Questions for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 21KB)
• Errata to the FDA Briefing Material for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 48KB)
• Errata to the FDA Briefing Material for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 16KB)
• Draft Agenda for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 19KB)
• Draft Roster for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 36KB)
• Briefing Information for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee
• BI Briefing Material for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 2655KB)
• Draft Agenda for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 20KB)
• Errata to the BI Briefing Material for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 66KB)
• Draft Roster for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 34KB)
• FDA Briefing Material for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 9248KB)
• FDA Briefing Material for the November 19, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 4191KB)
• Genentech Briefing Material for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 1026KB)
• Draft Questions for the November 18, 2009 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 21KB)