Posted on May 05, 2013

General and Plastic Surgery Devices Panel

• Sponsor Presentation: May 2, 2013  (PDF - 17.1MB)
• FDA Presentation: May 2, 2013  (PDF - 1.9MB)
• 24 Hour Summary: May 2, 2013  (PDF - 67KB)
• 2013 Meeting Materials of the General and Plastic Surgery Advisory Panel

Posted on May 03, 2013

Pediatric Advisory Committee

• Transcript of the March 14, 2013 Meeting of the Pediatric Advisory Committee  (PDF - 530KB)

Reproductive Health Drugs Advisory Committee

• Transcript for the March 4, 2013 Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD) (PM Session)  (PDF - 428KB)
• Transcript for the March 4, 2013 Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD) (AM Session)  (PDF - 411KB)
• Minutes for the March 4, 2013 Meeting of the Advisory Committee for Reproductive Health Drugs (ACRHD)  (PDF - 44KB)

Posted on May 02, 2013

Drug Safety and Risk Management Advisory Committee

• Transcript for the December 13, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 1.6MB)

Pulmonary-Allergy Drugs Advisory Committee

• Minutes for the April 17, 2013 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC)  (PDF - 35KB)

Posted on May 01, 2013

Reproductive Health Drugs Advisory Committee

• Minutes 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 - 36KB)

Medical Imaging Drugs Advisory Committee

• Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee (MIDAC) and Oncologic Drugs Advisory Committee (ODAC)
• Errata to the FDA Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (PDF – 75KB)  (PDF - 75KB)

Advisory Committee Calendar

• June 27, 2013: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Posted on April 30, 2013

Pediatric Advisory Committee

• The Challenges of Neonatal Product Development: An NIH Perspective  (PDF - 1.9MB)

General and Plastic Surgery Devices Panel

• Roster: May 2, 2013  (PDF - 15KB)

Medical Imaging Drugs Advisory Committee

• Committee Roster for the May 3, 2013 Meeting of the Oncologic Drugs Advisory Committee (ODAC)  (PDF - 30KB)
• Committee Roster for the May 3, 2013 Meeting of the Medical Imaging Drugs Advisory Committee (MIDAC)  (PDF - 23KB)
• Draft Meeting Roster for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee (MIDAC) and Oncologic Drugs Advisory Committee (ODAC)  (PDF - 185KB)
• Draft Agenda for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee (MIDAC) and Oncologic Drugs Advisory Committee (ODAC)  (PDF - 45KB)
• Teva Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (PDF – 257KB)  (PDF - 256KB)
• Genzyme Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (PDF – 1.74MB)  (PDF - 1.7MB)
• Amgen Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (PDF – 399KB)  (PDF - 399KB)
• NIAID Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (PDF – 1.78MB)  (PDF - 1.7MB)
• FDA Briefing Information for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (PDF – 4.88MB)  (PDF - 4.8MB)
• Draft Questions for the May 3, 2013 Joint Meeting of the Medical Imaging Drugs Advisory Committee (MIDAC) and Oncologic Drugs Advisory Committee (ODAC)  (PDF - 20KB)

Oncologic Drugs Advisory Committee

• Briefing Information for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee
• Delcath Briefing Information, Melblez Kit, for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF – 782KB)  (PDF - 781KB)
• FDA Briefing Information, Melblez Kit, for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF – 219KB)  (PDF - 222KB)
• AVEO Briefing Information, Tivozanib Capsules, for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF – 990KB)  (PDF - 990KB)
• FDA Briefing Information, Tivozanib Capsules, for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF – 143KB)  (PDF - 177KB)
• Committee Roster for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 32KB)
• Draft Meeting Roster for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 39KB)
• Draft Questions for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (AM Session)  (PDF - 18KB)
• Draft Questions for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PM Session)  (PDF - 18KB)
• Draft Agenda for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 22KB)

General and Plastic Surgery Devices Panel

• Voting Questions: May 2, 2013  (PDF - 85KB)
• Panel Questions: May 2, 2013  (PDF - 67KB)

Posted on April 29, 2013

Psychopharmacologic Drugs Advisory Committee

• Psychopharmacologic Drugs Advisory Committee Roster

Posted on April 26, 2013

Clinical Chemistry and Clinical Toxicology Devices Panel

• 24 Hour Summary  (PDF - 128KB)
• Presentation: Isoniazid  (PDF - 70KB)
• Presentation: PCP  (PDF - 70KB)
• Presentation: Methotrexate  (PDF - 86KB)

Advisory Committee Calendar

• May 3, 2013: Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting Announcement

Posted on April 25, 2013

Risk Communication Advisory Committee

• Safe Use Intiative Project Criteria Checklist  (PDF - 17KB)

General and Plastic Surgery Devices Panel

• FDA Executive Summary: May 2, 2013  (PDF - 550KB)
• Subject Photos  (PDF - 7KB)
• Patient Labeling Draft  (PDF - 355KB)
• Directions for Use Draft  (PDF - 611KB)
• SSED  (PDF - 562KB)