ICER Proposes Accelerated Approval Reforms Ahead Of FDA Meeting

By Beth Wang / April 27, 2021 at 11:53 AM
The Institute for Clinical and Economic Review on Monday (April 26) released a slate of 10 policy reforms FDA and payers could undertake to strengthen FDA’s accelerated approval pathway. Some of the policy suggestions, ICER says, constitute minor adjustments to the current accelerated approval path, while others “will be considered radical reconstruction of the entire process” that require congressional intervention, including the potential to create an annual renewal or “sunset” timeline for accelerated approvals that lack postmarket confirmatory evidence and...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.