A PC-Based Information Tracking System for Submissions at the FDA

The Division of Bioequivalence in the Office of Drug Standards at the Food and Drug Administration (FDA) has instituted a personal computer-based information management system for tracking submissions received by the Division. This system, which employs commercial software, allows for efficient and easy tracking of any submission in the Division. The program provides for useful and timely reports on all activity, which can be broken down in a variety of ways. The design of the system and its function within the Division are discussed as well as its application in other areas.