Current Status of the NDA Tracking System at the FDA

Abstract

At the beginning of the fiscal year (FY) 1987, the Center for Drug and Biologics (CDB)-FDA, implemented an upgraded version of the Management Information System (MIS) used previously to track new drug applications (NDAs), amendments, and supplements through the review process. This upgrade was part of the Centerwide Oracle Management Information System (COMIS) now under development at CDB. The presentation will focus on what COMIS adds to the previous system, the levels of information available to users, and future activities impacting on COMIS.