ARTICLE | Regulation

Departure of top FDA vaccine regulators a ‘huge loss,’ CBER Director Marks says

Resignations by Gruber, Krause catch agency, vaccine sponsors off guard

August 31, 2021 1:44 PM UTC
Updated on Aug 31, 2021 at 9:15 PM UTC

Resignation announcements Tuesday from FDA’s two most senior regulators responsible for oversight of vaccines, Marion Gruber and Phil Krause, surprised their colleagues at FDA, as well as vaccine developers and members of the public.

Gruber and Krause, director and deputy director, respectively, of the Office of Vaccines Research & Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), informed senior FDA executives of their decisions Tuesday morning. Gruber plans to end her 32-year FDA career on Oct. 31, and Krause will be leaving in November...