Medical CANDAs as a regulatory tool for clinical data review

Abstract

Faced with the task of submitting new drug applications and then waiting for the review process to end, a number of firms are participating in computer assisted new drug applications (CANDAs), the information technology exchange experiment between the Food and Drug Administration (FDA) and major pharmaceutical makers. The Merck Medical CANDA is an attempt to improve the situation by developing a PC-based, user-friendly system, under MS Windows 3.0, that facilitates quick access, review, assimilation, and presentation of clinical trial data, for the in-house medical and statistical review of the data, as well as for use at the FDA.<>