Adverse Reaction Reporting Requirements: An Update for Manufacturers *

Abstract

The regulation governing postmarketing surveillance, Section 314.80 “Postmarketing reporting of adverse drug experience” is found under title 21 of the Code of Federal Regulations. This regulation was published on Feb 22, 1985, and became effective on Aug 22, 1985. Since that time, changes have been made that have been addressed in regulations, guidelines, and workshops. These adjustments have served the purpose of fine-tuning the regulation by eliminating some requirements no longer appropriate, adding other requirements, and providing more direction and clarification to difficult areas. The following topics are discussed: old drugs, causality assessment, prescription drug therapy as an outcome, death reporting, active moiety reporting, therapeutic failure reporting, overdose reporting, follow-up reports, and increase in frequency. Also, a brief description of 15-day reports and periodic reports is provided, as well as definitions for several key terms that have changed over time.