FDA in the Shutdown: Drug Center Stays Open (Mostly); Ben Venue Does Not
This article was originally published in RPM Report
New drug approvals continued during the partial government shutdown, as user fees helped keep most of the FDA review functions running smoothly. The drug center did face some unusual challenges, including responding to a major manufacturing shutdown (by Ben Venue) – and to speculation about a leadership change at the drug center.
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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.
Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.