Home » FDA, Generic Makers Set User Fee Goals for Amendment Review
FDA, Generic Makers Set User Fee Goals for Amendment Review
July 15, 2011
The generic-drug industry and the FDA have agreed to a three-tier system of review goals for ANDA amendments under the generic-drug user fee program being negotiated. Review goals would vary depending on the number and type of amendments companies file, according to minutes from the latest meeting to establish the program.