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Mylan Warning Letter Exposes Challenges In Valsartan Supply Chain Chemistry

 
• By Bowman Cox

Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’

Warning Rubber Stamp
The US FDA warns its way into the pharma supply chain.

A warning letter to Mylan NV is yet another indication that in response to last year’s discovery of carcinogenic nitrosamines in active pharmaceutical ingredients for certain blood pressure medications, US Food and Drug Administration investigators are turning their attention further up the pharmaceutical supply chain.

There has been a growing focus on suppliers of APIs; now the spotlight is turning to the

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

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Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
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More from Compliance

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.