Clarifying the Regulatory Guidance on Manufacturing Process Changes

Time: 2:00 pm
day: Manufacturing - PM

Details:

• Outlining FDA processes for considering manufacturing changes for both investigational and licensed gene therapy products
• Highlighting common downfall areas where drug sponsors fail to demonstrate comparability
• Best practices for drug sponsors to communicate any process changes during drug development and in-market

Speakers:

Denise Gavin Denise Gavin, Ph.D., is the Director of the Office of Gene Therapy, in the Office of Therapeutic Products at the Center for Biologics Evaluation and Read more