Posted on September 10, 2012

Ophthalmic Devices Panel

• Jeremiah Brown: Curriculum Vitae  (PDF - 66KB)

Obstetrics and Gynecology Devices

• Lisa Moore: Curriculum Vitae  (PDF - 220KB)

Immunology Devices Panel

• Cherise Scott: Curriculum Vitae  (PDF - 347KB)
• James Reuben : Curriculum Vitae  (PDF - 968KB)

General and Plastic Surgery Devices Panel

• Sharon Timberlake : Curriculum Vitae  (PDF - 37KB)

Gastroenterology-Urology Devices Panel

• Abdelmonem Afifi: Curriculum Vitae  (PDF - 108KB)

Anesthesiology and Respiratory Therapy Devices Panel

• Winfred Wu: Curriculum Vitae  (PDF - 51KB)

Posted on September 06, 2012

Pediatric Advisory Committee

• Briefing Materials for the September 11, 2012 Meeting of the Pediatric Advisory Committee

Posted on September 05, 2012

Advisory Committee Calendar

• October 3, 2012: Science Board to the FDA Meeting Announcement

Science Board to the Food and Drug Administration

• Roden, Dan Mark CV  (PDF - 450KB)

Posted on September 04, 2012

Nonprescription Drugs Advisory Committee

• 2012 Meeting Materials, Nonprescription Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee

• Slides for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee
• Abbott Slides for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF – 4.69MB)  (PDF - 4.6MB)
• FDA Slides for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee (PDF – 606KB)  (PDF - 587KB)
• Final Meeting Roster for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 42KB)
• Final Questions for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 41KB)
• Final Agenda for the August 28, 2012 Meeting of the Gastrointestinal Drugs Advisory Committee  (PDF - 41KB)

Posted on August 31, 2012

Advisory Committee Calendar

• November 9, 2012: Nonprescription Drugs Advisory Committee Meeting Announcement

Pediatric Advisory Committee

• Vyvanse Use Review  (PDF - 291KB)
• Ofirmev Use Review  (PDF - 91KB)
• ella Use Review  (PDF - 306KB)
• Lastacaft Use Review  (PDF - 241KB)
• Moxeza Labeling (2/2012)  (PDF - 583KB)
• Moxeza Safety Review  (PDF - 160KB)
• Ofirmev Safety Review  (PDF - 620KB)
• Review: Death with the concomitant use of clonidine  (PDF - 249KB)
• Clonidine Adverse Event (3/2007)  (PDF - 492KB)
• Lastacaft Labeling (9/2011)  (PDF - 544KB)
• Kapvay Use Review  (PDF - 255KB)
• Lo Loestrin Fe Use Review  (PDF - 352KB)
• Augmentin XR Safety Review  (PDF - 259KB)
• Moxeza Use Review  (PDF - 204KB)
• Kapvay Safety Review  (PDF - 379KB)
• Ofirmev Medical Error Review  (PDF - 2.5MB)
• Aridol Safety Review  (PDF - 244KB)
• Afinitor Use Review  (PDF - 115KB)
• Elana Surgical Kit (HUD) Executive Summary  (PDF - 330KB)
• Vyvanse Safety Review  (PDF - 850KB)
• Lo Loestrin Fe Safety Review  (PDF - 146KB)
• Afinitor Safety Review  (PDF - 203KB)
• Augmentin XR Use Review  (PDF - 315KB)
• Beyaz Use Review  (PDF - 467KB)
• Beyaz Safety Review  (PDF - 416KB)
• ella Safety Review  (PDF - 204KB)
• Aridol Use Review  (PDF - 57KB)
• Lastacaft Safety Review  (PDF - 102KB)

Posted on August 30, 2012

Anti-Infective Drugs Advisory Committee

• Briefing Information for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee
• Novartis Briefing Information for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee (PDF – 2.16MB)  (PDF - 2.1MB)
• Errata to the FDA Briefing Information for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee (PDF – 144KB)  (PDF - 144KB)
• FDA Briefing Information for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee (PDF – 625KB)  (PDF - 624KB)