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

‘FDR’ Spells Process To Appeal FDA Rejections Of Requests For OTC Monograph Changes

Executive Summary

Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020. Others are OMOR, for OTC monograph order request, and OMUFA, for user fee program also authorized.

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

“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.

US OTC Monograph Overhaul Like Makeover To Resemble Other FDA Drug Application Programs

In draft guidance on format and content for OMORs, CDER framed recommendations by same model it’s used for guidances on other drug applications, common technical document for registration developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.

US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats

Submissions go to one of two addresses: OMORs, for changes or additions to monograph formulations and indications, go to the CDER NextGen Portal, and data, information and public comments on proposed or interim final orders go to OTC Monographs@FDA.

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