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David A. Kessler, MD
Food and Drug Administration Rockville, Md

JAMA. 1993;270(18):2180.

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In Reply.

—I appreciate Dr Faich's support for the FDA's new MEDWATCH program, and I agree with him that adequate follow-up of reports and epidemiologic assessment of signals are integral to any postmarketing surveillance program. MEDWATCH is but one very important component of such a program. Surveillance and data analysis cannot be conducted in the absence of good-quality reports of serious adverse events associated with medical products. Our first effort has thus been to increase the rate of reporting of serious adverse events and improve the quality of those reports through MEDWATCH educational activities.

Postmarketing surveillance and data analysis and epidemiologic studies have become increasingly important tools to monitor marketed medical products. When drugs are approved based on surrogate markers or preliminary data, as is sometimes the case with drugs for serious or life-threatening diseases, postmarketing studies are absolutely essential. Epidemiologic studies also provide useful safety and efficacy information about . . . [Full Text PDF of this Article]

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