Telavancin user fee deadline passes without FDA action
This article was originally published in Scrip
The user fee deadline for Theravance's antibiotic telavancin has passed without a US regulatory decision as the FDAapparently continues its investigation into the conduct of the pivotal Phase III trials.
You may also be interested in...
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.
There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.
Unlike AMAG's Makena, nearly all the products that have seen their accelerated approvals pulled have left the market quietly, our infographic shows.