Electronic Submission of Periodic Reports

Abstract

The US Food and Drug Administration has expanded its use of computers for the storage and analysis of adverse reaction reports and other postmarketing drug safety data. This article describes how the FDA uses this new technology to facilitate the entry processing and retrieval of periodic adverse drug reaction reports. The article briefly reviews some of the manufacturers' reporting requirements, describes the components of a periodic report, including the concept of electronic submission of data, and describes a PC-based FDA 1639 form data entry and retrieval system.