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Proposed OTC Switch Rule Anticipates Digital World

 
• By Malcolm Spicer

FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.

• Source: Shutterstock

A proposed US rule linking information not on a Drug Facts label to an OTC switch approval not long ago would’ve had stakeholders thinking of “behind the counter” distribution with pharmacy and other retail staff advising consumers about whether they should use a certain product.

The Food and Drug Administration’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule is all about information which won’t be printed on a DFl but...

ANCU OTCs Aren’t
Third Class Of Drugs

Any switch-approval rule change from the FDA wouldn’t extend to creating...

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Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
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Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

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Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
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Loper Bright ‘Might Not Be Cataclysmic’ With FDA’s ‘Good Reputation’ For Science – Attorney

 
• By Malcolm Spicer

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.