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Sign Of Normalcy? US FDA Schedules Meeting But Pauses Non-COVID Guidance Development

 
• By Derrick Gingery

As the agency and country plot the steps to reopening, a full resumption of activities still seems a long way off.

Stop Wait Go Glossy Button, Vector illustration

Those in the pharma industry looking for any sign of soon returning to normal life may have been encouraged by a recent Federal Register notice from the US Food and Drug Administration.

The agency announced a meeting on modernizing its data strategy was rescheduled for 30 June and will be held in-person...

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More from Regulation

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

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.”

More from Policy & Regulation

Xlear Lawsuit Argues To Shelve FTC Policy For Health Claim Substantiation Under Loper Bright

 
• By Malcolm Spicer

Complaint filed Utah federal court says “Supreme Court explicitly rejected Chevron deference to agency interpretations” in the Loper decision, compelling rejection of “an agency’s statutory interpretation unless the court, ‘after applying all relevant interpretive tools, concludes’ the interpretatio

People On The Move: Appointments At Pharma Deutschland, AMA, FSA

 
• By Tom Gallen

A round-up of the latest people moves: Pharma Deutschland names head of new OTC Market division; the African Medicines Agency appoints director general; the UK's Food Standards Agency adds members to novel foods committee.

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

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.