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?
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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.
Median review time held steady in 2019, but the percentage of NDAs the US FDA approved within six months jumped compared to recent years, a performance upswing all the more impressive because of the relatively high number of applications involved.