The Committee discussed pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act and the Pediatric Medical Device Safety and Improvement Act .
On March 6, 2017, the Committee discussed the following products (listed by FDA Center):
Center for Drug Evaluation and Research (CDER)
a. NITROPRESS (sodium nitroprusside)
b. KUVAN (sapropterin dihydrochloride)
FDA will provide the analysis of a possible safety signal regarding the use of the drug product EXJADE (deferasirox) in children with fever and dehydration, which was discussed at the September 2015 meeting.
The Committee will also discuss the role of pharmacogenomics in pediatric product development.
On March 7, 2017, the Committtee will discuss the following products (listed by FDA Center):
Center for Biologics Evaluation and Research (CBER)
a. EPICEL (cultured epidermal autografts) (humanitarian device exemption (HDE))
b. NOVOEIGHT (Antihemophilic Factor (Recombinant))
c. RIXUBIS Coagulation Factor IX (Recombinant)
Center for Devices and Radiological Health (CDRH)
a. IMPELLA RP SYSTEM (HDE)
b. LIPOSORBER LA-15 SYSTEM (HDE)
c. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)
See the SAC Tracker report