Meetings have long been touted as a tool to boost public confidence in COVID vaccines, but those looking for clean-cut answers may be unsettled to learn about the unknowns that come with all drug development, particularly that done at speed. Advisors are there to offer an ‘unvarnished’ view, committee member Paul Offit says in an interview with the Pink Sheet in advance of the the VBRAC’s 22 October meeting.
It’s not particularly unusual to spend eight-hours listening to a US Food and Drug Administration advisory committee poke hole after hole in a sponsor’s data, and then do a bit of a double-take when at the end of the day the majority of the committee votes in favor of the product’s risk-benefit profile.
At first glance it can be a little perplexing, but long-time FDA watchers know that in the world of drug...
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Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
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.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
