The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.
If the Food & Drug Administration had been able to hand-pick the first approval under the PDUFA V review process for novel drug and biologic applications, Bayer AG/Algeta ASA’s prostate cancer treatment Xofigo would seem like a pretty good choice.
After all, FDA cleared Xofigo for marketing a full three months before the user fee deadline – a fact the...
Create an account to read this article
Already a subscriber?
Approval in alpha- and beta-thalassemia by the Sept. 7 action date seemed assured, but an FDA review of a proposed REMS for potential liver injury pushed the decision to Dec. 7.
Heavy lobbying produced relief for orphan drugs in President Trump's budget reconciliation law and the cost of the changes to Medicare now is becoming clearer.
The FDA's release of CRLs for unapproved products could bring a court challenge, but for now, sponsors should expect all past and future letters will be made public, experts said.
Pink Sheet editors discuss the recent departure of a noted vaccine expert and many others from FDA advisory committee rosters, as well as the details and potential impact of the FDA’s release of dozens of complete response letters for unapproved products.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.
The Health and Human Services Secretary's Sept. 4 appearance at the Senate Finance Committee also revealed more Republicans are souring on his vaccine policies, although most still support him.
Center for Biologics Evaluation and Research Director Vinay Prasad and Commissioner Martin Makary will introduce the new pathway soon in a New England Journal of Medicine article.
