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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
When submitting information to the FDA in electronic format, sponsors should not confuse the “receipt date” with the “submission date” when filing documents reflecting regulatory milestones such as INDs, NDAs, ANDAs, BLAs and master files, according to finalized agency guidance. Read More
Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
New data collection methods show more trials than previously thought need to meet their postmarketing requirements (PMR) and postmarketing commitments (PMC), a new FDA report says. Read More
After fielding nothing but complaints with its proposed generic drug safety labeling rule, the FDA is receiving rare support for the proposal from a coalition of patient groups that says it would give injured consumers a clear avenue for redress. Read More