All articles tagged with #cber
Under acting director Karim Mikhail, the FDA’s Center for Biologics Evaluation and Research is trying to move past a turbulent period by holding adviser meetings and showing flexibility in accepting drug submissions, signaling a return to a more normal operating stance after Vinay Prasad's controversial tenure.
Vijay Kumar, acting director of FDA’s Office of Therapeutic Products that reviews cell and gene therapies, is stepping down and not renewing his detail. His departure comes amid broader leadership turnover at the agency’s Center for Biologics Evaluation and Research, where the cell-and-gene-therapy office is housed. Kumar had been promoted to lead the office by Vinay Prasad after Verdun’s ouster a little over a year ago, highlighting continuing leadership shake-ups within the FDA.
Vinay Prasad, a high-profile FDA official who oversaw vaccines, gene therapies, and rare-disease drug decisions, will leave the agency at the end of April amid ongoing leadership turnover and criticism over regulatory decisions and management style.