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House passes pediatric bill

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Executive Summary

House passes legislation codifying FDA's "pediatric rule" Nov. 19 by unanimous consent. Senate passed same language (S 160/HR 2957) in July following federal court ruling that FDA lacked statutory authority to require drug studies in children (1"The Pink Sheet" July 28, 2003, p. 4). President Bush is expected to sign the bill into law...

House passes legislation codifying FDA's "pediatric rule" Nov. 19 by unanimous consent. Senate passed same language (S 160/HR 2957) in July following federal court ruling that FDA lacked statutory authority to require drug studies in children (1 (Also see "FDA Pediatric Study Bill Clears Senate, Will Sunset With Exclusivity Grants" - Pink Sheet, 28 Jul, 2003.), p. 4). President Bush is expected to sign the bill into law....
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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