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Rulemaking For OTC Switch Process Changes Pushed To 2019

 
• By Malcolm Spicer

Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.

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FDA has pushed back the target date for the first step of rulemaking to change its rules for evaluating Rx-to-OTC switch proposals, changes that agency that have said are needed at once but won't come soon.

The US Department of Health and Human Services' annual spring update on regulatory priorities for FDA and its other agencies...

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EMA Says ‘No’ To Roche/Sarepta’s DMD Gene Therapy Elevidys

 
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Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
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Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

More from Pathways & Standards

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

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‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 
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• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.