December 11, 2003

Congress Gives FDA the Power to Require Pediatric Studies

Arnold & Porter Advisory

On December 3, 2003, President Bush signed the Pediatric Research Equity Act of 2003, Pub. L. No. 108-155, 117 Stat. 1936, which is available at This new statute amends the Federal Food, Drug, and Cosmetic Act ("FFDCA") by adding section 505B, which provides FDA with the statutory authority to require sponsors to submit assessments regarding the use of drugs and biologics in pediatric patients in certain specified circumstances.

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