Posted on September 14, 2012

Oncologic Drugs Advisory Committee

• Transcript for the July 24, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 472KB)

Posted on September 13, 2012

Pediatric Advisory Committee

• Pediatric Focused Safety Review: Vyvanse (lisdexamfetamine dimesylate)  (PDF - 184KB)
• Sponsor Presentation: Pediatric Safety Review of OFIRMEV (acetaminophen) Injection  (PDF - 3.2MB)
• Pediatric Focused Safety Review: Ofirmev (acetaminophen injection)  (PDF - 274KB)
• Medtronic Melody Transcatheter Pulmonary Valve (TPV) and Ensemble Transcatheter Valve Delivery System  (PDF - 6.9MB)
• Pediatric Focused Safety Review: Kapvay (clonidine hydrochloride)  (PDF - 130KB)
• Elana Surgical Kit HUD  (PDF - 5.3MB)
• Pediatric Focused Safety Review: Beyaz (ethinyl estradiol, drospirenone, levomefolate calcium)  (PDF - 207KB)
• Pediatric Focused Safety Review: Afinitor (everolimus)  (PDF - 224KB)
• Presentation Slides for the September 11, 2012 Meeting of the Pediatric Advisory Committee
• Final Agenda for the September 11, 2012 Meetiig of the Pediatric Advisory Committee  (PDF - 27KB)

Posted on September 12, 2012

Advisory Committee Calendar

• POSTPONED: October 15, 2012: Gastrointestinal Drugs Advisory Committee Meeting Announcement

Posted on September 11, 2012

Advisory Committee Calendar

• November 2, 2012: Anti-Infective Drugs Advisory Committee Meeting Announcement

Risk Communication Advisory Committee

• June 29, 2012: Presentations

Cardiovascular and Renal Drugs Advisory Committee

• Briefing Information for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee
• West-Ward Briefing Information, Phenylephrine Hydrochloride Injection, for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 7.07KB)  (PDF - 706KB)
• FDA Briefing Information, Phenylephrine Hydrochloride Injection, for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 10.91MB)  (PDF - 10.7MB)
• Cardiokine Briefing Information, Lixivaptan, for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 570KB)  (PDF - 570KB)
• Errata to the FDA Briefing Information, Lixivaptan, for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 80KB)  (PDF - 80KB)
• FDA Briefing Information, Lixivaptan, for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF – 4.46MB)  (PDF - 4.4MB)
• Committee Roster for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee  (PDF - 15KB)
• Draft Meeting Roster for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee  (PDF - 28KB)
• Draft Questions for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PM Session)  (PDF - 25KB)
• Draft Questions for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (AM Session)  (PDF - 24KB)
• Draft Agenda for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee  (PDF - 68KB)

Posted on September 10, 2012

Cardiovascular and Renal Drugs Advisory Committee

• Cardiovascular and Renal Drugs Advisory Committee Roster

Medical Imaging Drugs Advisory Committee

• Medical Imaging Drugs Advisory Committee Roster

Anti-Infective Drugs Advisory Committee

• Webcast Information for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 15KB)
• Slides for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee
• Novartis Slides for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee (PDF – 1.78MB)  (PDF - 1.7MB)
• FDA Slides for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee (PDF – 899KB)  (PDF - 779KB)
• Final Meeting Roster for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 137KB)
• Final Questions for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 74KB)
• Final Agenda for the September 5, 2012 Meeting of the Anti-Infective Drugs Advisory Committee  (PDF - 27KB)

Technical Electronic Product Radiation Safety Standards Committee

• Robert Uzenoff: Curriculum Vitae  (PDF - 36KB)
• Naoto Ueno: Curriculum Vitae  (PDF - 1.1MB)
• Stphen Szeglin: Curriculum Vitae  (PDF - 23KB)
• Paul Sorenson: Curriculum Vitae  (PDF - 194KB)
• Steven Smith: Curriculum Vitae  (PDF - 95KB)
• Stanley Savic: Curriculum Vitae  (PDF - 176KB)
• James Platner: Curriculum Vitae  (PDF - 26KB)
• Olga Naidenko: Curriculum Vitae  (PDF - 226KB)
• Cynthia McCollough: Curriculum Vitae  (PDF - 910KB)
• Margaret Foster: Curriculum Vitae  (PDF - 18KB)

Radiological Devices Panel

• Elisabeth George: Curriculum Vitae  (PDF - 31KB)

Ophthalmic Devices Panel

• Woodford Van Meter: Curriculum Vitae  (PDF - 550KB)
• Nicholas Tarantino: Curriculum Vitae  (PDF - 130KB)
• Joel Sugar: Curriculum Vitae  (PDF - 360KB)
• Thomas Steinemann: Curriculum Vitae  (PDF - 2.1MB)
• Lawrence Leguire: Curriculum Vitae  (PDF - 125KB)