‘Systemic’ changes coming to advisory committee process, FDA commissioner says

The FDA is preparing to release “systemic” changes to its advisory committee process, Commissioner Rob Califf said Wednesday, building on months of hints that a high-profile part of the drug review process might face major reforms.

Namandjé Bumpus

Califf offered few details other than saying that top leaders at the agency are still trying to reach an agreement on what changes are likely. The work is being led by Namandjé Bumpus, the FDA’s chief scientist and newly named deputy commissioner, he added.

“I think if you look right now, the advisory committees are working better, with better experts and people who know the field,” Califf said. “And this issue of whether to take a vote or not — the discussion of it is sharpened. I still believe we don’t need to take a vote in most meetings but there’s some where a vote is crucial…
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