A Regulatory Update on Postmarketing Drug Safety Surveillance

Abstract

Monitoring the safety of marketed drugs has been a concern in the United States and internationally for decades, and this concern is reflected in American regulations. The regulatory aspects of postmarketing drug safety surveillance have long been recognized and documented in American law and regulations. Though this safety monitoring has a long history, it remains a dynamic area for both industry and the Food and Drug Administration (FDA). The purpose of this paper is not to describe the regulatory history of drug safety surveillance, as that has been done before (1). Rather, the purpose of this paper is to provide an update on the regulatory aspects of postmarketing safety surveillance of drugs at FDA.