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Pediatric study bill

This article was originally published in The Tan Sheet

Executive Summary

FDA's authority to require drug sponsors to conduct trials in children would expire at the same time as the pediatric exclusivity incentive program under a bill passed by the Senate July 23. Amendment to S 650 makes the bill applicable to all NDAs submitted "on or after April 1, 1999," the same date FDA's pediatric rule first took effect. Amendment also explains how deferral or waivers granted by FDA would apply retroactively. American Academy of Pediatrics supported amendment, but opposed the bill along with Democratic Sens. Christopher Dodd (Conn.), Hillary Clinton (N.Y.), Edward Kennedy (Mass.)...

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