U.S. Food and Drug Administration

Managing the Risks From Medical Product Use:
Creating a Risk Management Framework

For every medical product FDA approves, the agency has to balance the benefits of the product against any risks it may pose. FDA's May 1999 report "Managing the Risks From Medical Product Use: Creating a Risk Management Framework," reviews the programs currently in place that help the agency make these decisions.

Managing the Risks from Medical Product Use
(Report to the FDA Commissioner from the Task Force on Risk Management)

Managing the Risks from Medical Product Use: Executive Summary

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(Hypertext created by clb 1999-JUL-06)