Challenges for the FDA: The Future of Drug Safety, Workshop Summary

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Table of Contents
Front Matter R1-R18
Summary 1-8
1 Introduction 9-12
2 Addressing the FDA's Resource Challenges 13-18
3 Strengthening the Scientific Base of the Agency 19-25
4 Integrating Pre- and Postmarket Review 26-31
5 Enhancing Postmarket Safety Monitoring 32-48
6 Conducting Confirmatory Drug Safety and Efficacy Studies 49-53
7 Enhancing the Value of Clinical Trial Registration 54-57
8 Enhancing Postmarket Regulation and Enforcement 58-69
9 Looking to the Future 70-77
References 78-80
Appendix A Workshop Agenda 81-92
Appendix B Speaker Biographies 93-110

the way the agency is structured; (3) the importance of improving information and communication about benefits and risks; (4) public–private collaboration so stakeholders can work together to accomplish shared goals; and (5) the agency’s regulatory authority.

Table of Contents

Front Matter R1-R18

Summary 1-8

1 Introduction 9-12

2 Addressing the FDA's Resource Challenges 13-18

3 Strengthening the Scientific Base of the Agency 19-25

4 Integrating Pre- and Postmarket Review 26-31

5 Enhancing Postmarket Safety Monitoring 32-48

6 Conducting Confirmatory Drug Safety and Efficacy Studies 49-53

7 Enhancing the Value of Clinical Trial Registration 54-57

8 Enhancing Postmarket Regulation and Enforcement 58-69

9 Looking to the Future 70-77

References 78-80

Appendix A Workshop Agenda 81-92

Appendix B Speaker Biographies 93-110