PDUFA Documents - Pediatric Exception Repealed
ALL PEDIATRIC SUPPLEMENTS THAT REQUIRE CLINICAL DATA FOR APPROVAL WILL BE REQUIRED TO PAY FEES EFFECTIVE JANUARY 4, 2002.
This is a result of section 5 of the "Best Pharmaceuticals for Children Act of 2001" signed by the President on January 4, 2002. It repealed the fee exception for pediatric supplements.
Therefore, if a supplement requires clinical data for approval, even if the supplement is for a new indication in pediatric populations, we would expect a fee, unless the supplement otherwise qualifies for a waiver or exception (e.g., orphan exception). Further, the exclusion box for pediatric supplements as noted on the user fee cover sheet is no longer applicable.
Revised, 1/8/2002, M.D. Jones