From 1983 to 1990 a number of lessons about postmarketing surveillance (PMS) were learned at FDA. Adverse drug reaction (ADR) reporting, regulations, processing and outputs changed during this period. While improved, reporting needs to be further stimulated and processing of reports must keep abreast of the inflow. Investigation of ADR signals requires a careful methodical approach. Pharmacoepidemiology must be seen, in addition to ADR monitoring, as the second critical element of PMS. Epidemiologically-based periapproval studies, use of linked databases and the conduct of cohort studies will become more prominent if regulatory and industry resource commitments are made.
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