An overview of the uses of the Food and Drug Administration (FDA) Adverse Drug Reaction Reporting system. The procedures for signal generation, monitored adverse reactions, safety conferences, and recommendations are presented. Use of the on-line retrieval system, periodic reports, and Freedom-of-lnformation requests is discussed.
SillsJM, FaichGA, MilstienJB, TurnerWM. Postmarketing reporting of adverse drug reactions to FDA: An overview of the 1985 guidelines. Drug Inf J.1986;20:151–6.
2.
SillsJM, TannerLA, MilstienJB. Food and Drug Administration monitoring of adverse drug reactions. Am J Hosp Pharm.1986;43:2764–2770.
3.
TurnerWM, MilstienJB, FaichGA, ArmstrongGD. The processing of adverse reaction reports at FDA. Drug Inf J.1986;20:147–150.
4.
AnelloC.Postmarketing surveillance legislation: Structure and results. Pharm Med.1988;879(2):11–22.
5.
NissmanEF, IezzoniDG. Report on a WHO ART-COSTART translation project. Drug Inf J.1989;23:75–79.
6.
COSTART.Available from DIA as hardcopy or diskettes and National Technical Information Service; Springfield, VA 22161. Available from NTIS as: 3.5-inch diskette (PB90-500190); 5.25-inch diskette (PB90-500208); Hardcopy Manual (PB90-114026/AS); or microfiche (PB90-114026/AS). Includes COSTART-WHO ART translation tables).
7.
KennedyDL, GoetschRA, DreisMW. Use and reported adverse effects of new chemical entities. Am J Hosp Pharm.1989;46:558–565.
8.
TomitaDC, BaumC, KennedyDL, KnappDE, PerryZA. Drug utilization in the U.S. 1987. Ninth annual review. National Technical Information Service; Springfield, VA 22161.
9.
PerryZA, KnappDE. Annual adverse drug reaction report: 1988. National Technical Information Service; Springfield, VA 22161. (PB89-191316/AS)
10.
KnappDE, PerryZA. Annual adverse biologic reaction report: 1988. National Technical Information Service; Springfield, VA 22161. (PB89-191308/AS)
