Advisory Committees
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Recently Updated Advisory Committee Materials
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Posted on September 14, 2012
Oncologic Drugs Advisory Committee
- Transcript for the July 24, 2012 Meeting of the Oncologic Drugs Advisory Committee (PDF - 472KB)
- 2012 Meeting Materials, Oncologic Drugs Advisory Committee
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Posted on September 13, 2012
Pediatric Advisory Committee
- 2012 Meeting Materials, Pediatric Advisory Committee to the Food and Drug Administration
- 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)
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Posted on September 12, 2012
Advisory Committee Calendar
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Posted on September 11, 2012
Anti-Infective Drugs Advisory Committee
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Advisory Committee Calendar
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Risk Communication Advisory Committee
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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)
- Webcast Information for the September 13, 2012 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (PDF - 27KB)
- 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)
- 2012 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
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Posted on September 10, 2012
Cardiovascular and Renal Drugs Advisory Committee
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Medical Imaging Drugs Advisory Committee
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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)
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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)
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Radiological Devices Panel
- Elisabeth George: Curriculum Vitae (PDF - 31KB)
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