SEND for CBER, What You Need to Know

FDA shares Center for Biologics Evaluation and Research’s (CBER’s) support and requirement for the Standard for the Exchange of Nonclinical Data (SEND), published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. FDA will discuss the pilot studies report, important data points for CBER non-clinical studies, and the FDA reviewer perspective.
Presenters:
Lisa Lin
Project Manager
Data Standards Team | Office of Director | Center for Biologics Evaluation and Research (CBER) | FDA
Nabil Al-Humadi, Ph.D.
Pharmacologist
Office of Vaccine Research and Review | CBER | FDA
Susan DeHaven, MSc
Director
Data Standards & Business Applications | Sanofi U

_______________________________ 
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
Phone - [phone] I [phone]