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Making Progress On Novel OTC Switch Rulemaking Has FDA Commissioner Nominee Califf’s Attention

 
• By Malcolm Spicer

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

Robert Califf in fornt of FDA building
• Source: FDA images combined

Robert Califf’s likely confirmation by the Senate would send him to the Food and Drug Administration commissioner post with him “mindful” that modernizing the agency’s Rx-to-OTC switch paradigm has been a regulatory goal for a decade.

Califf, who previously was commissioner for 11 months ending in January 2017, answered Health, Education, Labor and Pensions Committee members...

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EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
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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

Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
• By David Ridley

HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.

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

 
• By Malcolm Spicer

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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US Consumer Health Sector Vigilant To Avoid Stumbling On Trump’s Tariff Twists And Turns

 
• By Malcolm Spicer

In remarks at recent investor conference reflecting comments from across the US consumer health sector, Kenvue chief Thibaut Mongon says, “I'm going to state the obvious. The environment is very fluid.”

AESGP Annual Meeting: Consumer Health Sector Still Safe Bet For Investors

 
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A healthy diversity of different types of players and plenty of space for scaling up are among the reasons that investors remain interested in the consumer health sector, according to investment bankers speaking at the recent AESGP Annual Meeting.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.