CMC Initiative: Risk-Based CMC Reviews

12/20/00


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Table of Contents

CMC Initiative: Risk-Based CMC Reviews

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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

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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

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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)

Author: Chiu