FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises

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 agency made sure to highlight in its press...

More from United States

More from North America