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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.

User fees for the Food and Drug Administration’s OTC monograph program will be part of the agency’s third consecutive budget with its fiscal year 2023 appropriation, but the fees and the operations of the program they support still are new to some in the industry.

The OTC monograph program overhauled to be more effective and efficient under 2020 legislation resembles the FDA’s process for prescription...

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PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
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