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OTC Monograph FY2024 Proposal Fees Published As FDA Anticipates Change Requests Starting

 
• By Malcolm Spicer

“The agency anticipates a greater likelihood of OMOR submissions compared to prior fiscal years,” CDER says. In fourth year of initial five-year authorization of OMUFA, FDA getting ready to receive OMOR submissions from drug firms and other industry stakeholders.

• Source: Shutterstock

The US Food and Drug Administration’s work to modernize and streamline its OTC monograph system has reached the point in its fourth year that the agency, for the first time, published user fee rates for change requests before the start of fiscal year and separate from facility fees.

“The agency anticipates a greater likelihood of OMOR [OTC monograph order request] submissions compared to prior fiscal years,” said a Center for Drug Evaluation and Research representative.

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