Pediatric rule bill goes to Senate
Executive Summary
Senate Health Committee unanimously approves legislation codifying FDA's pediatric rule March 19. Chairman Judd Gregg's (R-N.H.) amendment adding a 2007 sunset to the bill passes by 11-10 vote. The "Pediatric Research Equity Act of 2003" (S 650) says FDA may require NDA sponsors and manufacturers of marketed drugs to submit data on pediatric safety, effectiveness, dosing and administration. Bill provides legislative backing for FDA rule after its defeat in federal court (1"The Pink Sheet" Oct. 21, 2002, p. 4)...
Senate Health Committee unanimously approves legislation codifying FDA's pediatric rule March 19. Chairman Judd Gregg's (R-N.H.) amendment adding a 2007 sunset to the bill passes by 11-10 vote. The "Pediatric Research Equity Act of 2003" (S 650) says FDA may require NDA sponsors and manufacturers of marketed drugs to submit data on pediatric safety, effectiveness, dosing and administration. Bill provides legislative backing for FDA rule after its defeat in federal court (1 , p. 4).... |