Electronic Study Data Submission; Data Standards; Recommending the Use of the World Health Organization Drug Dictionary

The Food and Drug Administration (FDA or Agency) is announcing support for the World Health Organization (WHO) Drug Dictionary (available at http://www.who-umc.org/), which is maintained and updated by the Uppsala Monitoring Centre. FDA is encouraging sponsors and applicants to use WHO Drug Dictionary codes in investigational study data provided in regulatory submissions to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. The WHO Drug Dictionary contains unique codes for identifying drug names and evaluating medicinal product information, including active ingredients and therapeutic uses. Typically, WHO Drug Dictionary is used to code concomitant medications used by subjects during the course of a clinical trial. WHO Drug Dictionary will be listed in the FDA Data Standards Catalog posted to FDA's Study Data Standards Resources Web site at http://www.fda.gov/forindustry/datastandards/ studydatastandards/default.htm