CBER/CDER electronic submissions workshop in September will focus on modifying case report forms.

Executive Summary

CBER/CDER ELECTRONIC CASE REPORT WORKSHOP SLATED FOR SEPTEMBER will concentrate on modification of case report forms into an electronic format, the Center for Biologics Evaluation & Research's Mary Buesing, MD, stated July 11 at a gene therapy workshop sponsored by the agency and the National Cancer Institute in Bethesda, Md. The planned autumn workshop, to be co-sponsored by the Drug Information Association, aims to "have industry involvement," Buesing noted. CBER and the Center for Drug Evaluation & Research also plan to release an Federal Register notice on the planned electronic format "as early as December this year," Buesing said.