Cavazzoni brings competence, continuity as CDER director

Patrizia Cavazzoni’s appointment as permanent director of FDA’s Center for Drug Evaluation and Research brings competence and continuity to one of the most important positions in the life sciences ecosystem.

While she is likely to focus on CDER’s COVID-19 response activities, Cavazzoni will be quickly thrust into the center of controversies involving product approvals, at the same time as needing to restore FDA’s reputation and morale in the wake of the Trump administration’s attacks on the integrity of the agency and its staff.  Some of her first high-profile decisions will involve CDER’s regulatory decision on aducanumab from Biogen Inc. (NASDAQ:BIIB), which has a June 7 PDUFA goal, as well as responses to public criticism from members of an FDA advisory committee of the center’s review of the proposed Alzheimer’s therapy. ...