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Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Ranbaxy’s regulatory woes deepened Thursday as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
To discourage GMP scofflaws, the European Medicines Agency is now publicly naming drugmakers that aren’t in line with current good manufacturing practices. Read More
Transparency and bribery — ying and yang — all but dominated global pharmaceutical headlines in 2013. “Sunshine” was cast on regulatory authorities and drugmakers in the U.S. and European Union. A number of industry associations and some individual companies also took steps to operate more transparently. The moves came as a major bribery scandal made waves in China, bringing pressure for more punishing antibribery rules. Meanwhile, the EU and India pushed forward with new clinical trial controls, and U.S. track-and-trace efforts advanced. With 2014’s script still a work in progress, take a look back at 2013 and use its lessons to plan your business strategy for the coming year.Read More
State governments are continuing their push to regulate compounding pharmacies, placing tighter restrictions on those compounders who stay out from under the voluntary regulations imposed by the Drug Quality and Security Act. Read More
Compounding pharmacies registering with the FDA for oversight are being drawn to the federal regulator by the appeal of knowing they meet the highest quality standards and to free themselves from complex and varied state laws. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More