Pediatric Exclusivity Expansion Floated On Hill; Mandatory Study Bill Pending
Executive Summary
An additional three months of exclusivity would be awarded for a company's second round of pediatric studies under a proposed amendment to Sen. Hillary Rodham Clinton's (D-N.Y.) bill to codify FDA's mandatory pediatric study rule
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Senate Health Committee passes "Women's Health Improvement Act" (S 2328) by voice vote Sept. 5. Bill includes amended version of Sen. Tom Harkin's (D-Iowa) pregnancy legislation, which would have directed FDA to enhance pregnancy drug labeling and would have given the agency authority to require postmarketing studies in pregnant women (1"The Pink Sheet" July 29, p. 11). No drug-related language is included in the final bill...
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