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