‘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.

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.

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