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Naloxone Still On US House Appropriators’ Radar, But OTC Access Remains Off Screen

FDA FY2022 Budget Report Comments On Switches, Acetaminophen Labeling, Homeopathics

 
• By Malcolm Spicer

Committee report again includes item concerning FDA’s work on expanding access to opioid antagonist naloxone. It still doesn’t acknowledge agency’s interest in making drug available OTC in a nasal inhaler, but emphasizes access for pregnant and postpartum women.

House appropriators’ changes in their comments on the US Food and Drug Administration’s work on expanding access to the opioid overdose remedy naloxone miss the point about making it available nonprescription as the agency has emphasized.

The Appropriation Committee’s report published with legislation for the FDA’s fiscal year 2022 funding along with budgets for the Department...

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FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

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.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

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

 
• By David Ridley

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

More from Policy & Regulation

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.

Innovations In US Hemp Market, Like States’ Regulatory Interest, More Than Skin Deep

 
• By Malcolm Spicer

Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

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.