US FDA’s Breakneck Approval Pace Clashes With Advisory Committee Mandate
FDA has approved more than 100 novel molecules in the past two years, almost all of them without an advisory committee stop. Is it time to revisit a 2007 law that was intended to assure a public vetting of NMEs prior to approval?
You may also be interested in...
FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?
FDA’s external advisory committee process is under increasing scrutiny within the agency and by the public – and the agency is continuing to be very sparing in convening actual reviews.
Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.