Posted on April 22, 2013

Pulmonary-Allergy Drugs Advisory Committee

• Final Agenda for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 41KB)

Posted on April 18, 2013

Cellular, Tissue, and Gene Therapies Advisory Committee

• Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

Posted on April 17, 2013

Oncologic Drugs Advisory Committee

• Waivers for Conflicts of Interest for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee

Advisory Committee Calendar

• April 30, 2013: Tobacco Products Scientific Advisory Committee Meeting Announcement

Oncologic Drugs Advisory Committee

• Disclosure Document for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF-13KB)  (PDF - 19KB)
• 18 U.S.C. 208(a) Waiver for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF-3555KB)  (PDF - 338KB)
• Disclosure Document for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF-12KB)  (PDF - 18KB)
• 18 U.S.C. 208(a) Waiver for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF-25KB)  (PDF - 31KB)

Advisory Committee Calendar

• March 20, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Circulatory System Devices Panel

• Transcript: March 20, 2013  (PDF - 1.2MB)
• 2013 Meeting Materials of the Circulatory System Devices Panel

Posted on April 16, 2013

Pulmonary-Allergy Drugs Advisory Committee

• Draft Meeting Roster for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 45KB)

Device Good Manufacturing Practice Advisory Committee

• Executive Summary  (PDF - 27KB)
• Panel Questions  (PDF - 30KB)
• Presentation: Extreme Weather Project  (PDF - 1.7MB)

Endocrinologic and Metabolic Drugs Advisory Committee

• 2013 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

Advisory Committee Calendar

• June 5-6, 2013: Joint Meeting of the Endocrinilogic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

Posted on April 15, 2013

Reproductive Health Drugs Advisory Committee

• Briefing Information for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM)
• Endo Briefing Information for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 6.28MB)  (PDF - 6.1MB)
• Errata to the FDA Briefing Information for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 55KB)  (PDF - 55KB)
• FDA Briefing Information for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 4.87MB)  (PDF - 4.8MB)
• Committee Roster for the April 18, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM)  (PDF - 18KB)
• Committee Roster for the April 18, 2013 Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD)  (PDF - 14KB)
• Draft Meeting Roster for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM)  (PDF - 49KB)
• Draft Questions for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM)  (PDF - 19KB)
• Draft Agenda for the April 18, 2013 Joint Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM)  (PDF - 38KB)

Device Good Manufacturing Practice Advisory Committee

• 24 Hour Summary  (PDF - 24KB)

Science Board to the Food and Drug Administration

• Minutes of the February 27, 2013 Meeting of the Science Board to the FDA  (PDF - 42KB)
• 2013 Meeting Materials, Science Board to the FDA
• Transcript of the February 27, 2013 Meeting of the Science Board to the FDA  (PDF - 360KB)

Pulmonary-Allergy Drugs Advisory Committee

• FDA Briefing Information for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 4.18MB)  (PDF - 4.2MB)

Posted on April 12, 2013

Pulmonary-Allergy Drugs Advisory Committee

• Briefing Information for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee
• GSK Briefing Information for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 2.19MB)  (PDF - 2.1MB)
• Errata to the FDA Briefing Information for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF – 78KB)  (PDF - 71KB)
• Committee Roster for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 18KB)
• Draft Questions for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 23KB)
• Draft Agenda for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 45KB)

Ophthalmic Devices Panel

• 24 Hour Summary: April 8, 2013  (PDF - 78KB)

Posted on April 11, 2013

Endocrinologic and Metabolic Drugs Advisory Committee

• Transcript for the January 10, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)  (PDF - 1.9MB)

Device Good Manufacturing Practice Advisory Committee

• Roster  (PDF - 5KB)

Ophthalmic Devices Panel

• Sponsor Presentation: April 8, 2013  (PDF - 5.8MB)
• FDA Presentation: April 8, 2013  (PDF - 529KB)
• Division Update  (PDF - 155KB)

Posted on April 10, 2013

Ophthalmic Devices Panel

• Panel Questions: April 8, 2013  (PDF - 65KB)
• Agenda: April 8, 2013  (PDF - 71KB)
• Voting Questions: April 8, 2013  (PDF - 48KB)

Device Good Manufacturing Practice Advisory Committee

• Agenda  (PDF - 16KB)

Posted on April 09, 2013

Arthritis Advisory Committee

• Minutes for the December 20, 2012 Meeting of the Arthritis Advisory Committee  (PDF - 29KB)

Pulmonary-Allergy Drugs Advisory Committee

• Minutes for the January 29, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee  (PDF - 26KB)

Psychopharmacologic Drugs Advisory Committee

• Webcast Information for the March 21, 2013 Meeting of the Psychopharmacologic Drugs Advisory Committee  (PDF - 21KB)