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GAO wants US FDA to show benefits of overseas inspections

The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.

Q&A with CEO and CMO

Medical marijuana chewing gum to treat IBS in Dutch trial

AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS). 

US FDA slams Suzhou Pharmaceutical Technology for copy and paste CoAs

Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA. 

US FDA criticises Sato Yakuhin Kogyo Co efforts to fix data issues

The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.

India clamps down on OTC antibiotic sales to stem spread of superbugs

The CDSCO has urged pharmacies to stop selling prescription antibiotics over-the-counter in an effort to slow the spread of antimicrobial resistance.

Janssen-Cilag switches Haldol supplies to Switzerland after production problems

Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.

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