CBER Gene Therapy Office May Be Isolated In FDA Reorganization Plan
Executive Summary
FDA's proposed transfer of therapeutic biologic reviews to the drug center could negatively affect the newly created CBER Office of Cellular, Tissue & Gene Therapies, Acting Director Phillip Noguchi, MD, said
You may also be interested in...
CBER/CDER Consolidation Receives McClellan’s Blessing; Tensions Continue
Incoming Commissioner Mark McClellan, MD/PhD, is indicating strong support of the shift of biological product reviews from the Center for Biologics Evaluation & Research to the Center for Drug Evaluation & Research
CBER/CDER Consolidation Receives McClellan’s Blessing; Tensions Continue
Incoming Commissioner Mark McClellan, MD/PhD, is indicating strong support of the shift of biological product reviews from the Center for Biologics Evaluation & Research to the Center for Drug Evaluation & Research
CBER/CDER Reorganization: Product Transfer Set, Resources Under Review
The CBER/CDER reorganization working group is finalizing a list of approved and investigational products whose reviews would be shifted from the Center for Biologics Evaluation & Research to the Center for Drug Evaluation & Research