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Postmarketing Risk Assessment of Drug Products
October 7, 2002

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Table of Contents

Postmarketing Risk Assessment of Drug Products

Postmarketing Risk Assessment: Why?

Postmarketing Risk Assessment: Why?

Postmarketing Risk Assessment: Goals

Postmarketing Risk Assessment: Tools

Adverse Event Reports System: AERS

Adverse Event Reports System: AERS

AERS Report Counts by Type: 1990 - 2001

Assessment of Spontaneous Reports

Assessment of Spontaneous Reports

Spontaneous Reporting System: Limitations

Factors Affecting Reporting

Factors Affecting Reporting for OTC Drugs

Spontaneous Reports are Not Enough!

Assessment of Other Evidence

Epidemiologic Evidence: Studies in Claims Databases

Epidemiologic Evidence: Prospective Observational Studies

Postmarketing Risk Assessment: What can we learn?

Postmarketing Risk Assessment: What can we learn?

Putting it All Together

Putting it All Together

The Way Forward

The Way Forward: PDUFA 3

Challenges Ahead

 Author:

Julie Beitz, MD
Director, Drug Risk Evaluation

Office of Drug Safety

Center for Drug Evaluation and Research

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FDA/Center for Drug Evaluation and Research
Last Updated: October 8, 2002
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