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Tylenol Label Warning Complaint Ruling Preempts OTC Monograph Federal Preemption Question

 
• By Malcolm Spicer

Preemption not discussed in ruling dismissing plaintiff experts’ testimony other than to note court previously rejected Kenvue’s motion to dismiss based on a preemption argument.

• Source: Shutterstock

A question about whether federal preemption precludes challenges to the safety and labeling of drugs available under a Food and Drug Administration OTC monograph won’t be answered in litigation alleging acetaminophen labeling fails to warn about potential risks.

Dismissal of testimony from experts for plaintiffs alleging that prenatal use of Tylenol or other acetaminophen oral products is linked...

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• By Malcolm Spicer

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

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• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

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