Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
Sen. Richard Burr is wondering whether industry should demand more protection in the user fee agreement, namely consequences for FDA if the agency does not meet the goals of the user fee agreements.
The North Carolina Republican asked during a recent Senate Health, Education, Labor and Pensions Committee hearing whether FDA should adjust...
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.
