For first time, FDA releases OTC drug user fees prior to start of government fiscal year

The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. While fees payable for OTC Monograph Order Request (OMOR) submissions have previously been published in March, six months after the start of the fiscal year, the fees are now being published prior to the start of the 2024 fiscal year. However, similar fees payable by manufacturing facilities have not yet been published and likely won’t be for another 6 months.

Regulatory background: User fees and over-the-counter (OTC) drug reform

Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.

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