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US FDA Should Reload Field Force To Target OTC Adulteration, Former Chief Counsel Hutt Says

 
• By Derrick Gingery

Habitually noncompliant companies are laughing at FDA, Peter Barton Hutt says.

• Source: Shutterstock

Former chief counsel Peter Barton Hutt says the US Food and Drug Administration looks "like fools" with a more than 30-year-old policy that has crippled its field force’s enforcement capabilities in OTC drug manufacturing.

Hutt recounted the 1991 creation of the FDA Office of Criminal Investigations, which removed all prosecutorial authority from the field...

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FDA Takes World Tour In Recent OTC Warnings

 
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FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
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The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

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

More from Policy & Regulation

FDA Takes World Tour In Recent OTC Warnings

 
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FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
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Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
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HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.