FDA, Industry Agreed In Theory On Need For OTC User Fees At Kick-Off Talks

June 20, 2016 at 4:32 PM
FDA recently kicked off discussions on developing a user fee program for over-the-counter (OTC) drug products, expounding on the lack of resources the agency has to finish outstanding monographs with a staff of only 18 full-time employees regulating a market of more than 100,000 products. Stakeholders across the spectrum agreed in theory on the need for user fees to supplement appropriations from Congress, but differed on how those fees should be assessed and raised concerns that a PDUFA-type model could...


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