Table of Contents
A Drug Quality System for the 21st Century
Breakout Session: Changes Without Prior Approval
Issues Discussed
Risk Analysis
Concerns and Suggestions
Comparability Protocols
Experiences with Comparability Protocols
Advantages with Comparability Protocols
Problems or Limitations with Comparability Protocols
Suggestions for Future
Development Reports Positive Feedback
Development Reports Positive Feedback
Development Reports Negative Feedback
Development Report Concerns
Other Risk-Based Approaches
Specific Recommendations for Opportunities for Less Burdensome Filing Requirements:
Other Systems
Next Steps
Next Steps
Future Workshops
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Author: Rick Smith, Aventis Pasteur, Inc.
April 24, 2003
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