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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Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020.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A draft guidance the FDA Center for Drug Evaluation and Research published on 22 June adds “formal dispute resolution”...

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IQVIA Consumer Health: Digestive Category Driving Global OTC Market Growth

 
• By David Ridley

An increasing awareness of and interest in gut health helped the global OTC market grow by 4.6% in value terms in 2024, according to IQVIA Consumer Health.

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• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

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• By David Ridley

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• By David Ridley

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More from Geography

IQVIA Consumer Health: Digestive Category Driving Global OTC Market Growth

 
• By David Ridley

An increasing awareness of and interest in gut health helped the global OTC market grow by 4.6% in value terms in 2024, according to IQVIA Consumer Health.

Self-Care Must Be Central To NHS Reform, Says UK Industry And Pharmacy Alliance

 
• By David Ridley

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• By Natasha Barrow

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