Advisory Committees
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Briefing Materials for the May 7 – 8 2012 Meeting of the Pediatric Advisory Committee
Persons with disabilities having problems accessing any of the PDF files below may call (301) 796-3634 for assistance.
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Briefing Materials
Disclaimer: Portions of these documents have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. Sec. 552).
Differin Lotion Safety Review (PDF - 204KB)Differin Lotion Use Review (PDF - 114KB)Differin Lotion Label 3-17-2010 - Differin Lotion Clinical Review (PDF - 1.5MB)
- Differin Lotion addendum Clinical Review (PDF - 38KB)
- Differin Lotion Pharmacology Review (PDF - 752KB)
- Differin Lotion Statisical Review (PDF - 417KB)
Dulera Safety Review (PDF - 187KB)Dulera Use Review (PDF - 93KB)- Dulera label 8-18-2011
- Dulera Clinical Review (PDF - 1.4MB)
- Dulera Pharmacology Review (PDF - 1.7MB)
- Dulera Statisical Review (PDF - 432KB)
- Gardasil Briefing Materials 12-7-2010 PAC meeting
- Gardasil Clinical Review 2010 (PDF - 454KB)
- Gardasil Clinical Review 2009 (PDF - 748KB)
Gardasil Label 12-22-2010 (PDF - 432KB)Gardasil Safety and Use Review (PDF - 317KB)- Gardasil Statistical Review 2010 (PDF - 1.2MB)
- Gardasil Statistical Review 2009 (PDF - 202KB)
Isopto Carpine Safety Review (PDF - 70KB)Isopto Carpine Use Review (PDF - 148KB)Isopto Carpine Label 7-8-2010 - Isopto Carpine Clinical Review (PDF - 4.1MB)
- Isopto Carpine Pharmacology Review (PDF - 462KB)
- Isopto Carpine Statistical Review (PDF - 1.4MB)
- Menveo Clinical Review 2011 (PDF - 682KB)
- Menveo Clinical Review 2010 (PDF - 759KB)
- Menveo Labeling 3-2011 (PDF - 281KB)
Menveo Safety and Use Review (PDF - 67KB)- Menveo Statistical Review 2011 (PDF - 620KB)
- Menveo Statistical Review 2010
MultiHance Safety Review (PDF - 409KB)MultiHance Use Review (PDF - 79KB)- MultiHance Label 12-20-2010
- MultiHance Clinical Review (PDF - 1.1MB)
- MultiHance Pharmacology Review (PDF - 455KB)
- MultiHance Statistical Review (PDF - 545KB)
Nasonex Safety Review (PDF - 327KB)Nasonex Use Review (PDF - 125KB)Nasonex Label 1-19-2011 - Nasonex Clinical Review (PDF - 155KB)
- Nasonex Statistical Review (PDF - 627KB)
Natazia Safety Review (PDF - 117KB)Natazia Use Review (PDF - 99KB)Natazia Label 3-2012 - Natazia Clinical Review (PDF - 1.9MB)
- Natazia Pharmacology Review (PDF - 494KB)
- Natazia Statistical Review (PDF - 391KB)
Omnaris Safety Review (PDF - 130KB)Omnaris Use Review (PDF - 106KB)Omnaris Label 10-2011 (PDF - 153KB)- Omnaris Clinical Review (PDF - 1.6MB)
- Omnaris Pharmacology Review (PDF - 165KB)
- Omnaris Statistical Review (PDF - 158KB)
Protonix Safety Review (PDF - 523KB)Protonix Use Review (PDF - 285KB)- Protonix Label 10-31-2011
- Protonix Clinical Review (PDF - 11.1MB)
- Protonix Clinical Review Addendum (PDF - 260KB)
- Protonix Pharmacology Review (PDF - 8.2MB)
- Protonix Statistical Review (PDF - 721KB)
Tamiflu Safety Review (PDF - 1.4MB)Tamiflu Use Review (PDF - 152KB)Tamiflu Nov 27, 2007 Safety review Slides Tamiflu 2007 Safety Update Slides Tamiflu Labeling 3-21-2011 Tamiflu Epidemiology Review (PDF - 266KB)Tamiflu Clinical Review Memo 2012 (PDF - 172KB)Tamiflu 2007 PAC Briefing materials Taxotere Safety Review (PDF - 188KB)Taxotere Use Review (PDF - 190KB)Taxotere Label 12-15-2011 - Taxotere Clinical Review (PDF - 1.5MB)
- Taxotere Pharmacology Review (PDF - 671KB)
- Taxotere Statistical Review (PDF - 427KB)
Viread Safety Review (PDF - 308KB)Viread Use Review (PDF - 147KB)Viread Label 1-18-2012 - Viread Clinical Review (PDF - 2.9MB)
- Viread Pharmacology Review (PDF - 474KB)
- Viread Statistical Review (PDF - 1.2MB)
Zylet Safety Review (PDF - 83KB)Zylet Use Review (PDF - 129KB)- Zylet Label 6-3-2010
- Zylet Clinical Review (PDF - 84KB)
Zymaxid Safety Review (PDF - 69KB)Zymaxid Use Review (PDF - 113KB)Zymaxid Label 5-18-2010 - Zymaxid Clinical Review (PDF - 3MB)
- Zymaxid Pharmacology Review (PDF - 119KB)
- Zymaxid Statistical Review (PDF - 611KB)
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