Vinay Prasad will leave his role as director of the FDA’s Center for Biologics Evaluation and Research at the end of April, the agency confirmed in multiple reports. Prasad’s tenure included high-profile rejections of several cell and gene therapies and internal reorganizations that drew criticism from rare-disease advocates and industry leaders. Sources: STAT, Fierce Biotech. The departures come amid heightened scrutiny of CBER review standards and public disputes over regulatory flexibility for rare-disease products. FDA Commissioner Marty Makary has been publicly associated with several of the agency’s recent policy shifts, and Prasad’s exit creates an immediate leadership gap in a center that oversees vaccines, gene therapies and blood products. Operationally, companies with pending biologics and gene-therapy applications will face uncertainty about review priorities and ongoing dialogues with CBER leadership. The agency has not named a successor, and industry contacts say transition planning will shape interactions on active regulatory submissions over the coming weeks.