Table of Contents
PhRMA Perspective on Risk Based CMC Review of Manufacturing Changes (Reducing CMC Requirements for Drugs of No or Low Risk with Respect to Quality)
Drugs of No/Low Risk
Drugs of No/Low Risk
Drugs of No/Low Risk
Phased Approach Desirable
Existing Guidance Structure Needs Support
PPT Slide
Specific Comments
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
What are the inclusion criteria?
Moving Guidance Forward (No/Low Risk + SUPACs)
Conclusions
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