FDA Names New Director to Lead Center for Biologics Evaluation and Research
The US Food and Drug Administration’s (FDA) Commissioner, Dr. Martin Makary, has named Vinay Prasad, M.D., M.P.H., a hematologist–oncologist, who most recently served as Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco (UCSF), as the New Director of the Center for Biologics Evaluation and Research (CBER). Dr. Makary made the announcement over the social media platform, X.
He succeeds Scott Steele, Ph.D., who has served as CBER’s Acting Director since early April (April 2025) following the resignation of Peter Marks, M.D., Ph.D., who announced his resignation as CBER’s Director in late March (March 2025) and who formally stepped down in early April (April 2025). Dr. Marks had served as CBER’s Director since January 2016 and had joined FDA in 2012 as Deputy Center Director for CBER.
In taking the helm at CBER, Prasad will be leading a center responsible for ensuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, tissues, and cell and and gene therapies. In addition to his role as professor at UCSF, Prasad runs the VKPrasad Lab, which studies cancer drugs, health policy, clinical trials and decision making in those areas.
CBER is one of two major centers regulating the bio/pharmaceutical industry. FDA’s Center for Drug Evaluation and Research (CDER) is a separate center within FDA, which is responsible for regulating over-the-counter and prescription drugs, including new molecular entities (chemically synthesized drugs) and biological therapeutics (i.e., recombinant proteins, monoclonal antibodies, immunomodulators [non-vaccine and non-allergenic products], and certain cytokines and growth factors) as well as generic drugs and biosimilars. CDER is now headed by Jacqueline Corrigan-Curay, J.D., M.D., who is serving as Acting Director of CDER. Prior to assuming the role of Acting Director of CDER in late April 2025, she was CDER’s Principal Deputy Center Director, a position she has held since July 2021.
