US OTC Monograph Reform Enters Electronic Age With Draft Guidance On Submission Formats
Executive Summary
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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In US OTC Monograph Program, ‘FDR’ Spells Appealing FDA's Rejections Of Change Requests
Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020.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.
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In draft guidance on format and content for OMORs, CDER framed recommendations by same model it’s used for guidances on other drug applications, common technical document for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 FDA Portal Open To Receive OTC Monograph Meeting Requests
Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.