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

Executive Summary

“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.

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US FDA Asks For Comments On Reauthorizing OMUFA, A Program Still New To OTC Industry

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In US OTC Monograph Program, ‘FDR’ Spells Appealing FDA's Rejections Of Change Requests

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