New CBER Director Appointed
FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
FDA Director Martin Makary announced on May 6, 2025 that he has appointed Dr. Vinay Prasad, MD, MPH as the director of FDA’s Center for Biologics Evaluation and Research. Prasad is a hematologist-oncologist and was previously a professor in the department of Epidemiology and Biostatistics at the University of California San Francisco (UCSF).
In a post on X, FDA Director Martin Makary stated (1), “I’m proud to welcome Dr. Vinay Prasad, MD, MPH, as the new head of FDA’s Center for Biologics Evaluation & Research. With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward. Welcome aboard, Dr. Prasad.”
According to an online biography, Prasad has run the VKPrasad lab at UCSF, “which studies cancer drugs, health policy, clinical trials and better decision making”, hosted an oncology podcast, and has authored more than 500 academic articles. He graduated from the University of Chicago Pritzker School of Medicine, Johns Hopkins Bloomberg School of Public Health, and Michigan State University (2).
According to media reports, Prasad has criticized the response to the COVID-19 epidemic and certain FDA proposals (3, 4). In March 2025, former CBER Director Peter Marks resigned, citing an “assault on scientific truth” and the current administration’s views on vaccines (4).
“Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said in his resignation letter (5). “As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”
References
- Makary, M. Post on X. May 6, 2025. https://x.com/DrMakaryFDA/status/1919802781466079264 (accessed May 7, 2025).
- https://vinayakkprasad.com/
- Sagonowsky, E. FDA Commissioner Marty Makary Taps Vinay Prasad to Head Up CBER. Fierce Pharma. May 6, 2025. https://www.fiercepharma.com/pharma/fda-commissioner-marty-makary-taps-vinay-prasad-head-cber
- Lawrence, L.; Mast, J.; and Herper, M. Vinay Prasad Tapped to Run FDA Center that Regulates Vaccines, Gene Therapies. STAT. May 6, 2025.
- Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by The New York Times.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
