Title: Change in production facility for a Monoclonal Antibody
Details: Need to develop a regulatory strategy for the US FDA that will be successful in meeting their requirements and expectations.
Important things need to be answered:
• What is the process and facility comparability strategy?
• What is the reporting mechanism to the FDA?
• Will you request a meeting with FDA? Why? What type? (need to add 30 days if you request a meeting with FDA)
• What type of change approval are you requesting and why? What is a summary of your analytical, process, facility studies and acceptance criteria?
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