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Overview of Postmarketing Safety Surveillance in FDA (For Drugs and Biologics)

 March 13, 2003

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Table of Contents

Overview of Postmarketing Safety Surveillance in FDA (For Drugs and Biologics)

Outline

Office of Drug Safety in CDER

Office of Drug Safety

Overall ODS Organization

Why Postmarketing? Limitations of Premarketing Clinical Trials

Beyond Approval- Postmarketing Monitoring

1962 Harris-Kefauver Amendments to FD&C Act

Current Regulations on Safety Reporting

Source of Reports

Sample MedWatch Form

What Manufacturers Must Report (21CFR 314.80)

Regulatory Definition of Serious (21 CFR 314.80)

AERS Report Counts by Type: 1990 through 2001

Factors Affecting Reporting

Limitations of Spontaneous Reports

Adverse Event Reporting System (AERS)

AERS Process Flow

ODS Safety Evaluators

Sample Screen of the AERS System

Sample Screen of the AERS System

Elements of a "Good" Report:

Signal Generation

Evaluation of Reports

Epidemiologic Assessment of Selected Safety Issues

Drug Safety Assessment

Communicating Safety Information Within the FDA

Regulatory Actions/Risk Management Recommendation to Review Division

Risk Communication

Author:
Min Chen, M.S., R.Ph.
Associate Director, Division of Drug Risk Evaluation 

Office of Pharmacoepidemiology and Statistical Science

Office of Drug Safety  

Center for Drug Evaluation and Research

Food and Drug Administration

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FDA/Center for Drug Evaluation and Research
Last Updated: March 13, 2003
Originator: OD
/OCTAP/DPDD
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