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FDA Asks Whether User Fees Will Repair OTC Monograph Process

FDA schedules a public meeting June 10 and opens a docket for stakeholder input on the potential development of a user fee program for OTC monograph drugs. CDER points out the OTC monograph is "one of the largest and most complex regulatory programs ever undertaken at FDA."

FDA expects that establishing user fees for the OTC monograph program would yield benefits including spurring product innovation by drug firms and timely evaluations by the agency on the safety of ingredients proposed for a monograph.

The agency scheduled a public meeting for June 10 and has opened a docket for stakeholder input on the potential...

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