Previously served as the Deputy Dir of CBER and Dir, Off of Vaccines Rsrch and Review. She was on the faculty of the Dept of Intl Health at Johns Hopkins Bloomberg Sch of Public Health, involved in the clinical development of investigational vaccines and an attending physician at the hospital.
ROBERT A. YETTER is the Associate Director for Review Management, CBER, FDA. He received a B.S. from Emory University, M.S. from Georgia State University and Ph.D. from the University of Florida. Prior to joining CBER, he spent six years at NIAID and four years in the Research Service DVA.
Previously served as the Deputy Dir of CBER and Dir, Off of Vaccines Rsrch and Review. She was on the faculty of the Dept of Intl Health at Johns Hopkins Bloomberg Sch of Public Health, involved in the clinical development of investigational vaccines and an attending physician at the hospital.
Description
This session will provide an overview of CBER's current work on ongoing initiatives, guidances, and regulations.
Learning Objectives: Summarize key issues discussed by CBER Identify regulatory hot topics in biologics.