Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs; Board on Population Health and Public Health Practice; Institute of Medicine
NAS Press | 2012 | ISBN: 0309221994 9780309221993 | 253 pages | PDF | 5 MB
Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs; Board on Population Health and Public Health Practice; Institute of Medicine
NAS Press | 2012 | ISBN: 0309221994 9780309221993 | 253 pages | PDF | 5 MB
This book evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions.
Written in response to a request by the FDA, Ethical and Scientific
Issues in Studying the Safety of Approved Drugs discusses ethical and
informed consent issues in conducting studies in the postmarketing
setting.
This book will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
CONTENTS
ABSTRACT
SUMMARY
1 INTRODUCTION
2 INCORPORATING BENEFIT AND RISK ASSESSMENT AND BENEFITRISK MANAGEMENT INTO FOOD AND DRUG ADMINISTRATION DECISION-MAKING
3 EVIDENCE AND DECISION-MAKING
4 SELECTION AND OVERSIGHT OF REQUIRED POSTMARKETING STUDIES
5 SYNTHESIS
A OTHER ELEMENTS OF THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT
? COMMITTEE'S LETTER REPORT
? OPEN SESSION AGENDAS
D DECISION CONFERENCING AND MULTICRITERIA DECISION ANALYSIS
E BENEFIT AND RISK ASSESSMENT AND MANAGEMENT PLAN DOCUMENT TEMPLATE
F COMMITTEE BIOSKETCHES
This book will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
CONTENTS
ABSTRACT
SUMMARY
1 INTRODUCTION
2 INCORPORATING BENEFIT AND RISK ASSESSMENT AND BENEFITRISK MANAGEMENT INTO FOOD AND DRUG ADMINISTRATION DECISION-MAKING
3 EVIDENCE AND DECISION-MAKING
4 SELECTION AND OVERSIGHT OF REQUIRED POSTMARKETING STUDIES
5 SYNTHESIS
A OTHER ELEMENTS OF THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT
? COMMITTEE'S LETTER REPORT
? OPEN SESSION AGENDAS
D DECISION CONFERENCING AND MULTICRITERIA DECISION ANALYSIS
E BENEFIT AND RISK ASSESSMENT AND MANAGEMENT PLAN DOCUMENT TEMPLATE
F COMMITTEE BIOSKETCHES
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