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JAMA. 1999;282:19.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has issued a 164-page report of its Task Force on Risk Management. The report and a separately available Executive Summary are on the FDA home page on the Internet at http://www.fda.gov/oc/tfrm/riskmanagement.pdf. Part 1 of the report provides a general discussion of the risks involved in medical product use and an overview of the risk management system and the FDA's role in that system. Parts 2 and 3 discuss the agency's premarketing and postmarketing risk assessment activities. Part 4 takes a broad look at the overall risk management system and makes recommendations for creating a new systems model.

The key recommendation of the task force is that the FDA convene a meeting or series of meetings with stakeholders (eg, health care professionals, health care provider organizations, patients, the public, and industry) to discuss the current system for managing risks and consult about various options identified in the report. . . . [Full Text of this Article]

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