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U.S. Department of Health and Human Services

Advisory Committees

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Final Agenda for the June 21, 2010 Meeting of the Pediatric Advisory Committee

Pediatric Advisory Committee Meeting
Monday, June 21, 2010
Bethesda Marriott Hotel,
5151 Pooks Hill Road,
Bethesda, Maryland, 20814

9:00 a.m.Welcome and Introductory RemarksGeoffrey Rosenthal, MD, PhD, Chair, PAC
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
9:10 a.m.Interactions with PAC members and other FDA Advisory CommitteesDianne Murphy, MD, Director
Office of Pediatric Therapeutics
OC, FDA
9:15 a.m.Abbreviated Presentations
  • Arimidex (anastrozole)
  • Casodex (bicalutamide)
  • OraVerse (phentolamine mesylate)
  • Desmopressin Acetate
  Questions and Recommendation		Judith Cope, MD, MPH, Medical Officer,
Office of Pediatric Therapeutics, OC, FDA
9:25 a.m.Apidra (insulin glulisine recombinant)
Standard Review of Adverse Events:
Questions and Recommendation		Elizabeth Durmowicz, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
9:40 a.m.NovoLog (insulin aspart [rDNA origin])
Standard Review of Adverse Events:
Questions and Recommendation		Elizabeth Durmowicz, MD, Medical Officer
10:00 a.m.Kogenate FS
(anti-hemophilic factor)
Standard Review of Adverse Events
Questions and Recommendation		Alan Ou, MD, MPH
Office of Biostatistics and Epidemiology,
CBER, FDA
10:30 a.m.Break     
10:45 a.m.

Nexium (esomeprazole magnesium)

Prevacid (lansoprazole)

Prilosec (omeprazole)

Aciphex (rabeprazole)

Standard Review of Adverse Events
Questions and Recommendation

Amy Taylor, MD, MHS, Medical officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
12:00Lunch 
1:00 p.m.Open Public Hearing 
2:00 p.m.Opening remarksDianne Murphy, MD, Director
Office of Pediatric Therapeutics
OC, FDA 
2:05 p.m.Division Brief Overview of Inhaled Anesthetics Use in Pediatric PatientsArthur Simone, MD, Medical Officer
Division of Anesthesia And Analgesia Products,
CDER, FDA
2:30 p.m.Sponsor Presentation on SupraneBaxter Representative
2:45 p.m.Questions and Answers 
3:00 p.m.Follow-up on Suprane (desflurane)
Questions and Recommendation		Virginia Elgin, MD, Medical Officer
Pediatric & Maternal Health Staff,
Office of New Drugs, CDER, FDA
3:30 p.m.Zemuron (rocuronium)
Standard Review of Adverse Events
Questions and Recommendation		Virginia Elgin, MD, Medical Officer
4:00 p.m.Overview on the Pediatric Device Consortia Grants Program Linda C. Ulrich, MD, FAAP
CAPT, U.S. Public Health Service
Medical Officer, Office of Orphan Products Development,
OC/ FDA
4:30 p.m.AdjournmentGeoffrey Rosenthal, MD, PhD, Chair
Director of Pediatric & Congenital Heart Center
Executive Director, Critical Care Services
University of Maryland Medical Center
Hospital for Children
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