FDA Pediatric Advisory Committee Meeting – September 19-20, 2013, Silver Spring, MD
On Thursday, September 19, 2013, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the for Pediatric Research Equity Act (Public Law 108-155) for Cervarix [human papillomavirus Bivalent (Types 16 and 18) vaccine]; Gammagard Liquid [Immune Globulin Infusion (human)]; Hemacord (hematopoietic progenitor cells, cord blood); Copegus & Pegasys (rivabirin and peginterferon alfa-2a); Chantix (varenicline tartrate); Isentress (raltegravir potassium); Intuniv (guanfacine), Topamax (topiramate); Faslodex (fulvestrant); Ixempra Kit (ixabepilone); and Plavix (clopidogrel bisulfate). An update on the pediatric trials for the drug program for Kidnet will be provided.
On September 20, 2013 the PAC will meet to discuss, as mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85), the Berlin Heart EXCOR Pediatric Ventricular Assist Device; Melody Transcatheter Pulmonary Heart Valve (TPV); and Elana Surgical Kit (HUD). The committee will also receive and discuss a report on the September 9-10, 2013 meeting of the Pediatric Ethics Subcommittee of the PAC concerning their discussion of the ethical issues involved in the development of pediatric medical countermeasures.
Walter Ellenberg, Ph.D.
Office of Pediatric Therapeutics
Office of the Commissioner
Food and Drug Administration
Bldg. 32, Room 5154
10903 New Hampshire Ave..
Silver Spring, Maryland 20993