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US FDA Doesn’t Budge On ‘ACNU’ Switch Requirements Questioned By OTC Industry

 
• By Malcolm Spicer

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.

(Source: Shutterstock/Citeline)

The US final rule for OTC switches available under “additional conditions for nonprescription use” taking effect on 27 January differs little from the proposed rule the Food and Drug Administration published more than two years ago other than insignificant textual changes to further clarify or explain the agency’s stated intent.

That’s not to say moving the agency’s proposal for targeting making more formulations available nonprescription through “novel switches” didn’t go...

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Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

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PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
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EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
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The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

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

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Perrigo Combines Americas, International Leads Into Global Post In Latest Move To Boost Results

 
• By Malcolm Spicer

Roberto Khoury, Perrigo’s international lead for a year, moves to CCO while his counterpart for the Americas region appointed in September 2023, Catherine "Triona" Schmelter, is leaving with her post eliminated in the firm’s changes.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
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