Safety
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Managing the Risks from Medical Product Use: Creating a Risk Management Framework
Report to the FDA Commissioner From the Task Force on Risk Management
U.S. Department of Health and Human Services
Food and Drug Administration
May 1999
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.
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Contents
Executive Summary Findings Conclusions, Recommendations, and Options Introduction Legislative And Management Initiatives Have Helped Speed Review Time Concerns Have Been Raised About The Effects Of PDUFA The Commissioner Asked The Task Force To Look Into Public Concerns About The Risk Management System Part 1: Background - What Are The Risks And What Is FDA's Role In Managing Risk? Goals Are To Maximize Benefit, Minimize Risk What ARE The Risks Involved With Using Medical Products? What Is FDA's Role In Minimizing Risk? Conclusions Part 2: Is The FDA Maintaining The Quality Of Its Premarketing Reviews? Has The Rate of Serious Adverse Events Increased? How Well Is The Agency's Quality Control System Working? What Factors In The Development Process Could Affect Risk Identification? Conclusions and Recommendations Part 3: How Does FDA Conduct Postmarketing Surveillance And Risk Assessment? Overall Postmarketing Risk Assessment Is Complex FDA Uses A Number Of Approaches To Assess Postmarketing Risk Initiatives Underway To Expand Postmarketing Risk Assessment Other Efforts Being Considered To Expand FDA's Postmarketing Risk Assessment Conclusions, Recommendations, And Options (Part 3) Part 4: Managing the Risks From Medical Product Use Current Risk Management For Medical Products Federal Risk Management Framework Is the Current Risk Management System Working? The Time Is Right For A New Systems Framework FDA's Overall Risk Management Activities Options For FDA In Risk Management Members of the Task Force Bibliography Acronym List Appendices Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Appendix I
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