Dr Peter Marks, who has been director of the FDA's Centre for Biologics Evaluation and Research (CBER) since 2016. The abrupt departure of Peter Marks as the director of the FDA's Centre for Biologics ...

Tracy Beth Høeg said she was fired; Katherine Szarama departs as acting CBER director but remains at FDA, signaling rapid ...

Makary’s departure followed internal disputes over approval decisions and Covid-19 vaccine posture, catalyzing a rapid ...

The Food and Drug Administration (FDA) has named Katherine Szarama to be the acting director of the unit in charge of regulating vaccines and other biological products for human use. An official for ...

Following the departure of Vinay Prasad, M.D., former head of the Center for Biologics Evaluation and Research (CBER), the FDA has already tapped someone else to temporarily fill his shoes. Freshly ...

FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important ...

Vinay Prasad has worked as a professor of medicine, haematologist/oncologist, and health policy researcher. Controversial doctor Vinay Prasad, a public health ...

The Center for Biologics Evaluation and Research (CBER) has published a list of the guidances it is considering publishing during 2026. They include guidances on chimeric antigen receptor (CAR) T ...

FDA leadership credited implementation of a 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified COVID-19 vaccine framework, and a “plausible mechanism” pathway for ...

FDA Commissioner Marty Makary on Tuesday named Vinay Prasad the next director of the U.S. Food and Drug Administration’s (FDA) Center of Biologics Evaluation and Research (CBER). Dr. Prasad has openly ...

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) met productivity milestones and continued product safety and biostatistics work, despite the pandemic ...