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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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More from Regulation

More from Policy & Regulation

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By Lauren Nardella

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.

Urban Wastewater Directive: AESGP Requests Intervention In EFPIA’s Legal Action

 
• By David Ridley

AESGP has formally submitted a request to the General Court of the European Union to intervene in the European Federation of Pharmaceutical Industries and Association’s legal action against the revised EU Urban Wastewater Directive.

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.