CBER/CDER electronic submissions workshop in September will focus on modifying case report forms.
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth