OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
Have a question for the town hall? Submit it to [email protected]! The FDA’s Center for Biologics Evaluation and Research, Office of Therapeutic Products (OTP) is hosting its next virtual town hall on June 4, 2026. During this town hall, experts from OTP’s Office of Review Management & Regulatory Review will answer questions regarding Biologic License Application (BLA) readiness, including how to request pre-BLA meetings, best practices for preparing submission packages, and tools to navigate the application process. Find more information about this town hall and other OTP events: https://www.fda.gov/news-events/otp-e...
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