Waiting For Congress: Reforming, Paying For FDA OTC Monograph Program

摘要

FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn't implement changes. FDA's performance goals for potential OTC monograph user fees make four references to Congress, a number exceeded within minutes during the agency's Aug. 23 webinar on the program's details that made it abundantly clear that Congress calls the shots on establishing the program.