The fiscal year 2023 US government funding bill moving through Congress this week includes accelerated approval pathway reforms aimed at giving the Food and Drug Administration more authority to ensure the timely enrollment and completion of confirmatory trials.
Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
