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US FDA Finds Zantac Poses Little Risk, But Concerns Linger

 
• By Bowman Cox

Ranitidine no more carcinogenic than grilled meat, the FDA’s Woodcock says, with NDMA levels well below those claimed by Valisure.

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zantac takes a grilling from the fda • Source: Shutterstock

Based on its test results to date, the US Food and Drug Administration 1 November again refrained from calling for consumers and patients to stop taking ranitidine products due to concerns about nitrosamine impurities that could cause cancer.

Agency tests found the N-Nitrosodimethylamine (NDMA) nitrosamine impurity in a range of oral solid and oral liquid dosage forms from...

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More from Manufacturing

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

More from Compliance

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.