FDA CBER Director Dr. Vinay Prasad will return to UCSF after completing a one-year sabbatical at the FDA, where he led key regulatory reforms and oversaw several biologics approvals, according to Commissioner Marty Makary.
Written By: Karthik Teja Macharla PharmD
Reviewed By: Pharmacally Editorial Team
Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA), will return to academia next month after completing a one-year sabbatical from the University of California, San Francisco (UCSF), according to a statement by FDA Commissioner Dr. Marty Makary.
In a public message shared on March 7 from his official X account, FDA Commissioner Dr. Marty Makary highlighted Prasad’s contributions during his tenure at the agency, noting that he implemented several long-lasting regulatory reforms while overseeing a significant number of biologics approvals. Makary also confirmed that the FDA will name a successor before Prasad’s departure next month.
Dr. Prasad joined the FDA in 2025 to lead the agency’s Center for Biologics Evaluation and Research, the division responsible for regulating vaccines, gene therapies, blood products, and other biologic medicines. His appointment marked a return to federal service during a sabbatical year from UCSF, where he serves as a physician-scientist and professor of epidemiology and biostatistics.
During his tenure at CBER, Prasad led a number of regulatory initiatives designed to strengthen clinical evidence and improve review efficiency. According to Makary, these efforts included implementing a “2-to-1” pivotal trial expectation for certain applications, introducing national priority reviews for biologics with major public health relevance, and developing a risk-stratified framework for COVID-19 vaccine evaluation. The agency also recently launched a new framework aimed at evaluating therapies for ultra-rare diseases, intended to provide a scientifically grounded path for innovative treatments targeting small patient populations.
Under Prasad’s leadership, the biologics center also recorded a notable number of regulatory decisions and approvals toward the end of 2025. Commissioner Makary noted that CBER achieved a record number of approvals in December, reflecting an active period of regulatory review across vaccines, gene therapies, and other biologic products.
Among the high-profile regulatory discussions during his tenure was the FDA’s review of Elevidys (delandistrogene moxeparvovec), a gene therapy developed for Duchenne muscular dystrophy. The therapy has been closely watched by the rare disease community and the biotechnology sector, highlighting the complexities involved in evaluating transformative gene-based treatments.
As he prepares to leave the agency, Prasad will return to his academic role at UCSF, where he has been widely known for his work in oncology, health policy, and evidence-based medicine. Commissioner Makary thanked him for his service and dedication, noting the personal sacrifice involved in stepping away from academic life and family responsibilities to serve in government.
The FDA is expected to announce a new director for CBER before Prasad’s departure, ensuring continuity in the oversight of vaccines, gene therapies, and other biologic products regulated by the agency.
Reference
Dr. Marty Makery, X, 07 March 2026, https://x.com/DrMakaryFDA/status/2030048453384929548
About Writer
Karthik Teja Macharla, PharmD,
He is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.