Regulatory Expectations for Comparability in Gene Therapy
Time: 3:00 pm
day: Conference Day Two
Details:
- Overview of the July 2023 FDA Draft Guidance on Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
- Practical considerations for comparability studies – determining when comparability is needed, appropriate analytical methods and study design, and effective data analysis strategies
- Recommendations for productive interactions with FDA when planning comparability
