Overhauling FDA's accelerated approval pathway: Key House committee chair pens new bill
House Energy & Commerce Committee Chair Frank Pallone (D-NJ) late Monday introduced new legislation that would revamp the way the FDA can tighten its reigns around accelerated approvals, which have seen rising numbers over the years, but no real way for the agency to quickly pull ones that have failed to confirm clinical benefit in a timely manner.
Specifically, the bill provides the FDA with a lot more discretion on how it can manage the accelerated approval program. The FDA’s Oncology Center of Excellence, which reviews the bulk of the accelerated approvals that come into the agency, held an advisory committee meeting last spring and has been working to move forward on either pulling or requiring further studies for some of these “dangling” accelerated approvals.
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