Pediatric Research Equity Act
This article was originally published in The Tan Sheet
Executive Summary
S 650 "will provide FDA with additional authority to require pediatric studies of pharmaceutical products when such studies are needed to ensure the safe and effective use of the products in children," agency notes in Nov. 19 release. Bill was presented to President Bush Nov. 21. An amendment linking the expiration of the S 650 to the pediatric exclusivity incentive program remains in the bill (1"The Tan Sheet" Aug. 4, 2003, In Brief)...
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