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Foreign API Manufacturers Help Ease Methotrexate Shortage

 
• By Martin Berman-Gorvine

Generic drug manufacturers needed to find additional manufacturers of active pharmaceutical ingredients to fill a gap in production of the vital cancer drug methotrexate.

FDA and drug manufacturers have alleviated a critical shortage of the widely used cancer drug methotrexate by identifying new international sources of active pharmaceutical ingredients, but the potential risks of using foreign API makers just a few years after the tainted heparin scandal cannot be far from anyone’s thoughts.

FDA Commissioner Margaret Hamburg announced at a Feb. 21 press conference that the agency had successfully worked with manufacturers to address the methotrexate shortage, along with that of Doxil (doxorubicin)...

More from Manufacturing

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.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

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

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.

More from Compliance

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

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.