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Reports to Congress

Reports to Congress on BPCA and PREA

Find reports on the implementation of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) and their impact on pediatric drug development.

Report to Congress on Pediatric Labeling of Orphan Drugs

Read about the status of labeling drugs for indications that have received an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to the use of such drugs in pediatric populations.

Report to Congress on the Pediatric Exclusivity Provision

Learn about the outcomes of the first pediatric drug development incentive legislation enacted in 1997 as part of the Food and Drug Administration Modernization Act (FDAMA).

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