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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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Women’s health bill

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...

Women’s health bill

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...

Pediatric study bill

Senate Health Committee adopts Sen. Hillary Clinton's (D-N.Y.) mandatory pediatric research bill Aug. 1 by voice vote. The bill (S 2394) would codify FDA's authority to require pediatric studies from sponsors and award six months exclusivity. Final language does not include an amendment proposed by Sen. Christopher Bond (R-Mo.) that would have awarded three months additional exclusivity for a second round of pediatric studies (1"The Pink Sheet" July 29, p. 11)...

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