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When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Purdue Pharma wants immediate-release opioids subjected to the restrictive labeling and postmarketing studies now required for extended release and long-acting (ER/LA) products such as the company’s flagship drug OxyContin. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More
The FDA is examining how drug manufacturers exchange transaction data with their business partners to see if data-gathering methods already in use could satisfy new federal track-and-trace requirements. Read More
Dynavax is withdrawing a European marketing authorization application for the Heplisav hepatitis B vaccine over concerns with adequate safety information. Read More
Chelsea Therapeutics’ orphan blood-pressure drug Northera won FDA approval Tuesday, following a rocky review path that included two advisory panel nods and a complete response letter. Read More
The FDA has selected 13 drugmakers to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More
Actavis plans to buy Forest Labs in a $25 billion deal that would expand the company’s reach into the primary care market and add to its pipeline in a wide range of diseases. Read More
Roughly a quarter of 78 drugmakers surveyed recently doubt they will be able to meet federal deadlines for implementing new track-and-trace requirements. Read More