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Statin In Technology-Assisted OTC Study May Be First To Take ‘Fail-First’ Step For ‘ACNU’ Switch

 
• By Malcolm Spicer

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

(Source: Shutterstock/Citeline)

A study completed in 2024 showing strong results for consumers using an online application to accurately self-select and safely use an Rx statin drug could set the stage for the first “additional conditions of nonprescription use” OTC switch application submitted for the US Food and Drug Administration’s consideration.

Other questions also are worth considering about the agency’s recently published final rule, which takes effect on 27...

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• By Tom Gallen

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Xlear Lawsuit Argues To Shelve FTC Policy For Health Claim Substantiation Under Loper Bright

 
• By Malcolm Spicer

Complaint filed Utah federal court says “Supreme Court explicitly rejected Chevron deference to agency interpretations” in the Loper decision, compelling rejection of “an agency’s statutory interpretation unless the court, ‘after applying all relevant interpretive tools, concludes’ the interpretatio