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Home » New Requirements Imposed on Pediatric Drug and Biologic Trial Sponsors
New Requirements Imposed on Pediatric Drug and Biologic Trial Sponsors
November 14, 2007
The FDA Amendments Act (FDAAA) of 2007 modifies the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) to require additional reviews of pediatric drug and biologic clinical trials by an internal FDA committee.