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Will Influences Behind US FDA's Delayed Approval For OTC Plan B Also Shadow ‘Plan A’ Switch?

 
• By Malcolm Spicer

FDA history with emergency contraceptives and opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, Valley Surgical Clinics founder and advocate for making more drugs available OTC, the agency will approve HRA Pharma's NDA for OTC 0.075-mg norgestrel.

• Source: Shutterstock

An Arizona surgeon and advocate for making more pharmaceutical products available OTC isn’t sure the Food and Drug Administration is ready to approve the change for a drug he’s singled out as a prime candidate, daily oral contraceptives.

The FDA’s history with emergency contraceptives and with opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, president emeritus and founder...

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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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Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

 
• 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

People On The Move: Appointments At Klosterfrau, Haleon, Opella

 
• By Tom Gallen

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AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• 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