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Advisory Committees

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Draft Agenda for the December 7, 2010 Meeting of the Pediatric Advisory Committee

Pediatric Advisory Committee Meeting
Tuesday, December 7, 2010
Bethesda Marriott Hotel,
5151 Pooks Hill Road,
Bethesda, Maryland, 20814

8:00 a.m.Welcome and Introductory RemarksGeoffrey Rosenthal, MD, PhD
Chair of Pediatric Advisory Committee
Director of Pediatric & Congenital Heart Center
Executive Director, Critical Care Services
University of Maryland Medical Center
Hospital for Children

Walter Ellenberg, PhD
Designated Federal Official, Pediatric Advisory Committee
Office of Pediatric Therapeutics,
Office of Special Medical Programs, OC, FDA
8:05 a.m.Agenda OverviewDianne Murphy, MD, Director
Office of Pediatric Therapeutics
OC, FDA
8:10 a.m.Brief Summary of recent Advisory Committees:
  • Gastrointestinal Drug Advisory Committee
  • Cardiovascular-Renal Drugs Advisory Committee
Geoffrey Rosenthal, MD, PhD
Chair of Pediatric Advisory Committee
Director of Pediatric & Congenital Heart Center
Executive Director, Critical Care Services
University of Maryland Medical Center
Hospital for Children
 Discussion 
8:30 a.m.Abbreviated Presentations

Acanya Gel (clindamycin/benzoyl peroxide combination)


Ulesfia Lotion 5% (benzyl alcohol)
Judith Cope, MD, MPH, Medical Officer,
Office of Pediatric Therapeutics
OC, FDA
 
 Questions and recommendations 
8:35 a.m.Epiduo Gel (adapalene and benzoyl peroxide)
Standard Review of Adverse Events
Elizabeth Durmowicz, MD, Medical Officer
Pediatric & Maternal Health Staff,         
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
9:05 a.m.Post-marketing Monitoring of Vaccine SafetyRickey Wilson, JD, MD, Director
Division of Epidemiology
Office of Biostatistics & Epidemiology (OBE)
CBER, FDA
 Questions  
9:35 a.m.Pre-licensure Safety Data:
GARDASIL [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant]
Jeffrey Roberts, MD, Medical Officer
Division of Vaccines and Related Product Applications
Office of Vaccines Research & Review
CBER, FDA
 Questions  
10:10 a.m.Break 
10:25 a.m.Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, 18) Vaccine Recombinant)
Standard Review of Adverse Events   
Michael Nguyen, MD, Medical Officer
Division of Epidemiology,
Office of Biostatistics & Epidemiology (OBE),
CBER, FDA
 Questions and Recommendations  
11:35 a.m.Xyzal (levocetirizine dihydrochloride)
Standard Review of Adverse Events
Amy Taylor, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
12:00 a.m.Lunch  
1:00 p.m.Open Public Hearing 
2:00 p.m.Flovent HFA
Standard Review of Adverse Events
Virginia Elgin, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
 Questions and Recommendation  
2:30 p.m.Neulasta (pegfilgrastim)
Standard Review of Adverse Events
Alyson Karesh, MD, Medical Officer
Office of New Drugs
CDER, FDA
 Questions and Recommendation  
3:00 p.m.Prezista (darunavir ethanolate)
Standard Review of Adverse Events
Alyson Karesh, MD, Medical Officer
Office of New Drugs
CDER, FDA
 Questions and Recommendation  
3:30 p.m.Break 
3:45 p.m.PegIntron (peginterferon alfa-2b)
Standard Review of Adverse Events
Alyson Karesh, MD, Medical Officer
Office of New Drugs
CDER, FDA
 Questions and Recommendation 
4:15 p.m.Axert (almotriptan)
Standard Review of Adverse Events
Virginia Elgin, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
4:45 p.m.Lamictal and Lamictal XR (lamotrigine)
Standard Review of Adverse Events
Virginia Elgin, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
5:15 p.m.Depakote ER (divalproex sodium)
Follow-up analysis of data from June 23, 2009 PAC on neurodevelopment delay
M. Lisa Jones, MD, MPH, Medical Officer
Division of Neurology Products
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
5:45 p.m.AdjournmentGeoffrey Rosenthal, MD, PhD
Chair of Pediatric Advisory Committee
Director of Pediatric & Congenital Heart Center
Executive Director, Critical Care Services
University of Maryland Medical Center
Hospital for Children