Postmarketing Reporting of Adverse Drug Reactions to the FDA: An Overview of the 1985 FDA Guideline

Abstract

The new regulation for reporting adverse drug reactions (ADRs) to the FDA, 21 CFR 314.80, went into effect August 23, 1985. Major changes from the previous regulation include revision of the definition of a 15-Day Report, the establishment of a structured Periodic Report and reports of increased frequency of ADRs, and changes in submission requirements for foreign, literature and study reports. This article reviews the new regulation and provides an overview of the Guideline for Postmarketing Reporting of Adverse Drug Reactions with regard to report sources, reporting vehicle, report types, and time frames.

Keywords

FDA Federal regulation Adverse reaction FDA Guideline Periodic reports 15-Day Reports

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References

21 CFR 314.80. Federal Register, 1985; 50(36), p 7500.

Report to the Secretary of the Department of Health and Human Services by the United States General Accounting Office. FDA can further improve its adverse drug reaction reporting system. HRD-82-37, March 8, 1982.

Draft Guidelines for Postmarketing Reporting of Adverse Drug Reactions, Docket No. 85D-0249, August 23, 1985.