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.
Nightingale SL. Risk Management Report Issued. JAMA. 1999;282(1):19. doi:10.1001/jama.282.1.19