The Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).
The Committee will meet to discuss the following products (listed by FDA Center):
(1) Center for Drug Evaluation and Research
(2) Center for Devices and Radiological Health
a. FLOURISH (Humanitarian Device Exemption (HDE))
b. ACTIVA (HDE)
c. LIPOSORBER (HDE)
d. IMPELLA RP SYSTEM