Vinay Prasad will depart his role overseeing vaccines and biologics at the U.S. Food and Drug Administration at the end of April, ending a tumultuous tenure marked by several high‑profile regulatory reversals and industry clashes. Prasad served as director of the Center for Biologics Evaluation and Research and also held the agency’s chief scientific and medical officer title during his term. His decisions prompted public disputes with drugmakers and patient advocates over the agency’s handling of vaccine and rare‑disease submissions, including a public reversal on the review of a Moderna flu vaccine application and recent scrutiny of gene‑therapy protocols. The departure leaves the CBER leadership post vacant and injects near‑term uncertainty into reviews of vaccines, cell therapies and gene‑editing products. Replacement plans have not been finalized by FDA leadership.
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