FDA Encourages Applicants to Use WHO Drug Dictionary in Submissions

The Food and Drug Administration is encouraging sponsors and applicants to use the World Health Organization (WHO) Drug Dictionary in investigational study data provided in regulatory drug submissions, according to a notice published March 31 in the Federal Register (80 Fed. Reg. 17,047).

The WHO Dictionary, which is maintained and updated by the Uppsala Monitoring Centre, contains unique codes for identifying drug names and evaluating medicinal product information, including active ingredients and therapeutic uses, the agency said. Typically, the dictionary is used to code concomitant medications used by subjects during a clinical trial.

The use of a ...