U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. . Center for Biologics Evaluation and Research FDA.
Notice: Archived Document
The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
Center for Biologics Evaluation and Research FDA
Site Visit Introduction
Carolyn A. Wilson, Ph.D.
Associate Director for Research
To ensure the safety, purity, potency, and effectiveness of biological products, including vaccines, blood and blood products, and cells, tissues and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions or injury.
FD&C and PHS Acts Combined with Regulations
Review of Data
Submitted to IND
Rational Policy and Decisions
CBER researcher =“Researcher-Regulator”~10% CBER Staff
Integration of research and review ensures
Relevance, Expertise, Timeliness, and Usability
REVIEW AND INPUT
CBER RESEARCH MANAGEMENT OVERVIEW
Ensure safety, efficacy and availability of biologic products and use and development of appropriate regulatory pathways through
*FY09, Developed by CBER’s Research Leadership Council
Evaluation used to allocate research resources
“…CBER has a rigorous process for establishing priorities and the impact of Center research on regulation. In addition, the leadership of CBER insists upon integration of laboratory scientists both in the review and manufacturing site inspection process. External peer review of research programs is the norm rather than the exception.”