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Sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, facility. 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
The European Commission is looking for drugmakers to participate in pilots on early dialogue with health technology assessors, with the aim of better aligning new product development and HTA requirements. 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
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More