From L-R: Prevision Policy's Kate Rawson, OCE director Rick Pazdur, Hopkins professor Caleb Alexander, CBER deputy director Celia Witten, and OND Director Peter Stein (Zachary Brennan for Endpoints News)

Ad­vi­so­ry com­mit­tee votes aren't go­ing away with in­com­ing re­forms, FDA of­fi­cials say

WASH­ING­TON — Two top lead­ers from the FDA said changes to the agency’s ad­vi­so­ry com­mit­tee process won’t elim­i­nate the up-or-down votes whose ne­ces­si­ty Com­mis­sion­er Rob Califf has ques­tioned in re­cent months.

The goal of the com­ing ad­comm re­forms is to make the process as ef­fi­cient as pos­si­ble, Pe­ter Stein, di­rec­tor of the FDA’s Of­fice of New Drugs, ex­plained to the Bio­phar­ma Con­gress in Wash­ing­ton on Mon­day. That in­cludes stan­dard­iz­ing de­ci­sion-mak­ing for when to hold the ad­vi­so­ry meet­ings, Stein said, and bring­ing more con­sis­ten­cy to how dif­fer­ent agency cen­ters and di­vi­sions con­duct the dis­cus­sions.

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