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Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies. Read More
Sen. Claire McCaskill (D-Mo.) is taking the FDA to task for its delayed reaction in targeting companies marketing supplements containing oxilofrine, a stimulant banned by the World Anti-Doping Agency for athletes. Read More
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Weighing the risks and benefits of Intercept Pharmaceuticals’ obeticholic acid, an FDA advisory committee voted unanimously 17-0 on the significance of alkaline phosphatase levels as evidence to justify an accelerated approval of the primary biliary cirrhosis candidate. Read More
With the completion of the Senate HELP Committee’s third and final markup on biomedical innovation legislation, a complete cures package is expected to hit the full Senate shortly. Read More
Gaping GMP holes in Swedish contract manufacturer Apotek Produktion & Laboratorier’s processes resulted in a seven-item Form 483 following an Oct. 5 to 9, 2015 inspection. Read More