The Office of Epidemiology and Biostatistics, Division of Drug and Biologic Product Experience in the Center for Drugs and Biologics, FDA, receives about 40,000 reports each year from manufacturers and voluntarily from physicians and other health professionals. How well these reports are managed has direct public health implications. This paper reviews the current and proposed regulations on reporting adverse drug reactions (ADRs) to the FDA, reports on an internal evaluation of the procedures used for processing ADR reports, and discusses organizational and procedural changes recently implemented that relate to managing ADR reports.
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FDA Can Further Improve its Adverse Drug Reaction Reporting System, General Accounting Office, March 8, 1982.
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21 Code of Federal Regulations, “310.300 Subpart D, Records and Reports,” p 27, April 1, 1984.
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New drug and antibiotic regulations.Federal Reporter, vol 47, no. 202, Tuesday, October 19, 1982, proposed rule, pp 46622–46666.
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ADR Task Force Report, The Office of Epidemiology and Biostatistics, December 20, 1983.
