For Industry

PDUFA Documents - Pediatric Exception Repealed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 It repealed the fee exception for pediatric supplements.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  Further, the exclusion box for pediatric supplements as noted on the user fee cover sheet is no longer applicable.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

Page Last Updated: 05/03/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English