Charge to the Committee
Committee’s Approach to Its Charge
Benefit–Risk Assessment and Management Throughout a Drug’s Lifecycle
Evidence and Decision-Making
Selection and Oversight of Required Postmarketing Studies
Responses to the Charge Questions
Findings and Recommendations
The Evolution of the Food and Drug Administration’s Responsibilities in the Postmarketing Setting
The Context of This Report
The Committee’s Approach to Its Charge
Overview of the Report
2 INCORPORATING BENEFIT AND RISK ASSESSMENT AND BENEFIT–RISK MANAGEMENT INTO FOOD AND DRUG ADMINISTRATION DECISION-MAKING
Evaluating Benefit and Risk Over a Drug’s Lifecycle
The National Academies of Sciences, Engineering, and Medicine 500 Fifth St. N.W. | Washington, D.C. 20001
Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Institute of Medicine "Front Matter."
Ethical and Scientific Issues in Studying the Safety of Approved Drugs.
Washington, DC: The National Academies Press, 2012.
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