Standards for CANDAs;do CALs Standards Point the Way?

Abstract

The Food and Drug Administration (FDA) and the Pharmaceutical Industry are looking to emerging information technologies, particularly optical imaging as applied in Computer Assisted New Drug Applications (CANDAs), to improve the New Drug Application regulatory cycle. However, no single hardware/software system has emerged as the “standard.” The Department of Defense Computer Assisted Logistics (CALS) initiative is a program to improve control of the vast amount of information associated with technical procurements. The CALS approach to setting document interchange standards could provide a road map for a similar initiative within the Pharmaceutical Industry