PhRMA Perspective on Risk Based CMC Review of Manufacturing Changes (Reducing CMC Requirements for Drugs of No or Low Risk with Respect to Quality)

12/20/00


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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

Author: rz29411