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Testing Ranitidine With Too Much Heat Could Generate NDMA, FDA Says

 
• By Malcolm Spicer

FDA recommends using "Liquid Chromatography-High Resolution Mass Spectrometry Method" for testing ranitidine rather than method apparently used by online pharmacy Valisure, which asked agency to halt production and order recalls.

Research analyst adding reagent to drug to keep tracking chemical reaction - Image

The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratories' use of the incorrect test for the drug ingredient.

The FDA on 2 October announced a recommendation to use the "Liquid Chromatography-High Resolution Mass Spectrometry Method" (LC-HRMS) for testing...

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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

 
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AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
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More from Policy & Regulation

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.”

FDA Proposes Requiring Unit-Dose Packaging For Orally Disintegrating OTC Monograph Drugs

 
• By Malcolm Spicer

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

 
• By Malcolm Spicer

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu