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U.S. Department of Health and Human Services

Advisory Committees

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Final Agenda for the March 22, 2010 Meeting of the Pediatric Advisory Committee

Monday, March 22, 2010
Bethesda Marriott Hotel,
5151 Pooks Hill Road,
Bethesda, Maryland, 20814

 

8:00 a.m.Welcome and Introductory Remarks

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

Doreen Kezer, MSN
Executive Secretary, Pediatric Advisory Committee
Office of Science and Health Coordination
OC, FDA

8:05 a.m.

Agenda Overview

 

Dianne Murphy, MD, Director
Office of Pediatric Therapeutics
OC, FDA
8:15 a.m.Anthelios 40  sunscreen
Cardiolite (technetium Tc-99m)
Nasacort AQ (triamcinolone)
Viramune (nevirapine)
Judith Cope, MD, MPH, Medical Officer,
Office of Pediatric Therapeutics
OC, FDA
 Abbreviated Presentations 
 Opportunity for questions 
8:30 a.m.Introduction to CBER VaccinesRobert Wise, MD, MPH, Deputy Director
Division of Epidemiology
CBER, FDA
8:50 a.m.DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) Standard Review of Adverse Events   David Menschik, MD, MPH, Medical Officer
Division of Epidemiology
CBER, FDA
 Questions and Recommendation 
9:10 a.m.PENTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)
Standard Review of Adverse Events
Jane Woo, MD, MPH, Medical Officer
Division of Epidemiology
CBER, FDA
 Questions and Recommendation 
9:30 a.m.KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
Standard Review of Adverse Events
Jane Woo, MD, MPH, Medical Officer
Division of Epidemiology
CBER, FDA
 Questions and Recommendation 
10:15 a.m.Break 
10:30 a.m.Valtrex (valacyclovir)
Standard Review of Adverse Events
Felicia Collins, MD, MPH, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
10:45 a.m.Zmax (azithromycin)
Standard Review of Adverse Events
Virginia Elgin, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
 Questions and Recommendation 
11:00 a.m.Follow-up on FDA Early Communication Regarding Reports of Liver-Related Adverse Events in Patients Taking Orlistat Lisa Mathis, MD, Director,
Pediatric Maternal Health Staff
Office of New Drugs, CDER, FDA
11:30 a.m.Lunch 
1:00 p.m.Open Public Hearing 
1:15 p.m.Topical Calcineurin Inhibitors: Elidel and Protopic Follow-up Presentation: Introduction and Background; Division Update on RegistriesAmy Woitach, DO, MS, Medical Officer, DDDP
CDER, FDA
1:45 p.m.Malignancies in Children:  Background RatesLogan Specter, Ph.D
Epidemiology
University of Minnesota
2:30 p.m.Safety and Drug Utilization ReviewLois LaGrenade, MD, MPH, Medical Officer
Division of Pharmacoviligance I
OSE, CDER, FDA
3:00 p.mSponsor PresentationsNovartis Elidel (pimecrolimus)
Astellas Protopic (tacrolimus)
 Clarification Questions  
 Questions and Recommendation 
4:30 p.m.ROTARIX (Rotavirus Vaccine, Live, Oral)
Standard Review of Adverse Events
Wei Hua, MD, MPH, Medical Officer,
Division of Epidemiology
CBER, FDA
 Questions and Recommendation 
5:30 p.m. AdjournGeoffrey Rosenthal, MD, PhD, Chair
Director of Pediatric & Congenital Heart Center
Executive Director, Critical Care Services
University of Maryland Medical Center
Hospital for Children