Table of Contents
CMC Initiative: Risk-Based CMC Reviews
PPT Slide
PPT Slide
Objectives
Reduction of CMC Submission Requirements for Little or No Risk Drugs
Reduction of CMC Submission Requirements for Little or No Risk Drugs
Important Points
PPT Slide
Drug Substances Attributes and Acceptance Criteria for the Listed Drugs
Drug Product Attributes and Acceptance Criteria for the Listed Drugs
Safety Considerations Attributes and Acceptance Criteria for the Listed Drugs
GMP Considerations Attributes and Acceptance Criteria for the Eligible Manufacturers
Proposed Process
PPT Slide
Working Group Members Yuan-yuan Chiu Frank Holcombe Pat Alcock Dan Boring Peter Cooney Eric Duffy James Dunnie Melissa Egas Ajaz Hussain Vilayata Sayeed Paul Schwartz M. Welschenbach (e.s.) Liang Zhou Maria Kowblansky (alt)
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