The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant to FDAAA.

FDAAA Pediatric Tracking Requirements

In accordance with section 505A (Best Pharmaceuticals for Children Act of 2007 (BPCA)) and section 505B (Pediatric Research Equity Act of 2007 (PREA)) of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), this website provides information resulting from pediatric studies conducted in response to a Written Request issued under BPCA and pediatric assessments conducted under PREA. Unless otherwise noted, these reports contain information from both CDER and CBER.