OTC Monograph User Fees Grow In FDA FY2023 Budget Request And In Industry's Thinking

 
• By Malcolm Spicer

Stakeholders didn’t indicate extensive familiarity with OTC monograph user fees during online workshop. Biden administration’s FDA FY2023 budget request includes $5m increase to $30.36m in facility registration fees required from all firms manufacturing OTC monograph drugs available in US.

The justification document included with the FDA's FY2023 budget request offered information on OTC monograph user fees and the agency's work in the program.

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