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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

 
• By Malcolm Spicer

Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020.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.

• Source: Shutterstock

An acronym associated with disagreement with US Food and Drug Administration decisions and already known to firms marketing drugs available through applications also could become common for manufacturers of OTC monograph drugs, FDR.

A draft guidance the FDA Center for Drug Evaluation and Research published on 22 June adds “formal dispute resolution”...

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