Prasad’s ouster at FDA raises prospect of CBER reset

The forced ouster of Vinay Prasad as director of FDA’s Center for Biologics Evaluation and Research has widened the confidence intervals around predictions about FDA’s regulation of medical products.

The move could be good news for companies that saw approval goalposts moving under Prasad. At the same time, the disruption caused by rapid turnover of leadership makes a challenging regulatory environment even more difficult. ...