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From the Food and Drug Administration |

Risk Management Report Issued

Stuart L. Nightingale, MD
JAMA. 1999;282(1):19. doi:10.1001/jama.282.1.19.
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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.

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