Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

 

Posted on August 31, 2012

Advisory Committee Calendar

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

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Pediatric Advisory Committee

• Briefing Materials for the September 11, 2012 Meeting of the Pediatric Advisory Committee
• Beyaz Safety Review  (PDF - 416KB)
• ella Safety Review  (PDF - 204KB)
• Aridol Use Review  (PDF - 57KB)
• Lastacaft Safety Review  (PDF - 102KB)
• Vyvanse Use Review  (PDF - 291KB)
• Ofirmev Use Review  (PDF - 91KB)
• ella Use Review  (PDF - 306KB)
• Lastacaft Use Review  (PDF - 241KB)
• Draft Agenda for the September 11, 2012 Meetiig of the Pediatric Advisory Committee  (PDF - 48KB)
• Augmentin XR Use Review  (PDF - 315KB)
• Beyaz Use Review  (PDF - 467KB)
• Afinitor Safety Review  (PDF - 203KB)
• Lo Loestrin Fe Safety Review  (PDF - 146KB)
• Vyvanse Safety Review  (PDF - 850KB)
• Elana Surgical Kit (HUD) Executive Summary  (PDF - 330KB)
• Afinitor Use Review  (PDF - 115KB)
• Aridol Safety Review  (PDF - 244KB)
• Ofirmev Medical Error Review  (PDF - 2.5MB)
• Kapvay Safety Review  (PDF - 379KB)
• Moxeza Use Review  (PDF - 204KB)
• Augmentin XR Safety Review  (PDF - 259KB)
• Lo Loestrin Fe Use Review  (PDF - 352KB)
• Kapvay Use Review  (PDF - 255KB)
• Lastacaft Labeling (9/2011)  (PDF - 544KB)
• Clonidine Adverse Event (3/2007)  (PDF - 492KB)
• Review: Death with the concomitant use of clonidine  (PDF - 249KB)
• Ofirmev Safety Review  (PDF - 620KB)
• Moxeza Safety Review  (PDF - 160KB)
• Moxeza Labeling (2/2012)  (PDF - 583KB)

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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)
• Webcast Information for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 13KB)
• Committee Roster for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 97KB)
• Draft Meeting Roster for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 104KB)
• Draft Questions for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 77KB)
• Draft Agenda for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 94KB)
• 2012 Meeting Materials, Anti-Infective Drugs Advisory Committee

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Posted on August 29, 2012

Endocrinologic and Metabolic Drugs Advisory Committee

• Transcript for the March 29, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee  (PDF - 1.8MB)
• 2012 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee

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Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• Topic 2: Biosimilars – An Update (PDF - 5.49MB)  (PDF - 5.6MB)
• Topic 1: Tablet Scoring (PDF - 906KB)  (PDF - 880KB)
• Topic 2: Nanotechnology – Update on FDA Activities (PDF - 2.05MB)  (PDF - 2MB)
• Topic 1: Uses and Limitations of In Vitro Dissolution Testing (PDF - 3.35MB)  (PDF - 3.8MB)