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

 
• By Malcolm Spicer

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.

The Center for Drug Evaluation and Research also was explicit during the 90-minute webinar that the program will not produce...

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More from Policy & Regulation

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