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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 January, allowing new drug applications to request approval for drugs,...

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Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

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Proponent For Age-Restricting Diet Supplement Sales Adds ‘Health Inequities’ To Argument

 
• By Malcolm Spicer

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