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Pediatric study bill

Executive Summary

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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