U.S. Food and Drug Administration Center for Drug Evaluation and Research
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Postmarketing Risk Assessment of Drug Products
Postmarketing Risk Assessment: Why?
Postmarketing Risk Assessment: Goals
Postmarketing Risk Assessment: Tools
Adverse Event Reports System: AERS
AERS Report Counts by Type: 1990 - 2001
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?
Putting it All Together
The Way Forward
The Way Forward: PDUFA 3
Challenges Ahead
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FDA/Center for Drug Evaluation and Research Last Updated: October 8, 2002 Originator: OTCOM/DLIS HTML by MAU