FDA Perspective on Computer Assisted Pharmacology/Toxicology Review

Abstract

The Food and Drug Administration (FDA) has been working with industry for a number of years to integrate computers into the review process. Most of these efforts have focused on the clinical section of a new drug application. A logical extension of this effort is the use of computers to aid in the review of the nonclinical pharmacology/toxicology data for new drugs. As a result of discussions with industry, the FDA began to develop the concept of a computer assisted pharmacology/toxicology review. The Center for Drug Evaluation and Research at FDA, along with the Pharmaceutical Manufacturers Association (PMA) has formed a working group to evaluate the use of computers in the evaluation of the pharmacology/toxicology information submitted to the FDA. The goal of the committee is to develop a mechanism to facilitate the computerized review of data for the pharmacology/toxicology submissions. This article describes the FDA perspective on the use of the computer in the review of pharmacology/toxicology data