Congress mulls softer accelerated approval reforms as part of user fee reauthorizations
Newly proposed, must-pass bipartisan legislation that pays the FDA over the next five years for its reviews of new medical products may also include new provisions allowing the FDA to require confirmatory trials to be underway prior to granting accelerated approvals.
The shift would spell bad news for companies that win accelerated approvals but drag their feet in conducting the required confirmatory trials.
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