US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews

Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.

advisory committee
• Source: Shutterstock

The US Food & Drug Administration’s ongoing review of the advisory committee process likely will result in the agency holding more panel discussions overall – and especially in cases where there has been a “major change” in the application, FDA Commissioner Rob Califf said during a Health Affairs webinar earlier this month.

“In general, it would be good practice to reconvene advisory panels when there is a major change,” he said in response to a question about lessons learned from the 2021 Aduhelm advisory committee and subsequent accelerated approval

More from US FDA Performance Tracker

More from Regulatory Trackers