A Task and Problem Focused Approach to the Development and Regulation of Drugs

This paper describes an approach by which the pharmaceutical industry and the Food and Drug Administration (FDA) can communicate and interact more effectively in the drug development process. An electronic system is proposed that with constant updating would organize data and other information by issues. These issues—tasks and problems—would be carefully expressed, only as can be justified by available data. Using a shared task and problem list and an electronic space in which communication is captured, developers and evaluators would interactively resolve these issues in a stepwise fashion. This approach encompasses aspects of information and project management. It would also support the evolution of good review practice and increase understanding of the drug evaluation process. This proposal is intended to improve the effectiveness, efficiency, and speed of drug review at FDA without adding any burden to drug developers.