Vinay Prasad, MD, the FDA’s top regulator of vaccines and cell and gene therapies, will step down at the end of April, an agency spokesperson confirmed to Becker’s.
Dr. Prasad joined the agency in 2025 on a one-year sabbatical from the University of California, San Francisco. During his tenure as director of the federal government’s Center for Biologics Evaluation and Research, he oversaw the implementation of several initiatives, including a 2-to-1 trial requirement for drug approvals, the creation of a national priority review system, a new COVID-19 vaccine framework and a “plausible mechanism” pathway for ultra-rare diseases.
Dr. Prasad had resigned in July amid criticism from advocacy groups related to his stance on certain drug approvals. He returned to the agency in August at the FDA’s request.
In a March 6 post on X, FDA Commissioner Marty Makary, MD, thanked Dr. Prasad for his “service and personal sacrifice to take time away from his family” and said the FDA will name a successor before his departure.
At Becker's 4th Annual CEO + CFO Roundtable, taking place November 2–5 in Chicago, more than 1,500 hospital and health system executives tackle decisions that determine whether organizations thrive or merely survive: protecting margins under cost pressure, choosing where to grow, renegotiating payer relationships, stabilizing the workforce and proving real ROI on technology. This is where leaders work through them together, face-to-face. Apply for complimentary registration now.
