OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products - 06/04/2026
The FDA's Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), has scheduled a virtual town hall for June 4, 2026, to discuss best practices for Biologic License Application (BLA) submissions. Experts from the Office of Review Management and Regulatory Review (ORMRR) will address questions regarding BLA readiness for cell and gene therapy products.
Sponsors, manufacturers, and regulatory professionals involved in the development and submission of BLAs for cell and gene therapy products.
This event indicates a continued focus by CBER OTP on streamlining the transition from clinical phases to marketing authorization for complex biologics. For industry professionals, this suggests an opportunity to gain clarity on technical submission hurdles and FDA expectations for 'readiness.' Engagement in these forums may help sponsors avoid common filing deficiencies or Refusal to File (RTF) actions by aligning with ORMRR's current review standards.
Regulatory and CMC leads should prepare specific technical questions regarding BLA formatting, data readiness, and submission requirements for cell and gene therapy products. Teams should review internal BLA readiness checklists against current CBER/OTP expectations prior to the June session.
The FDA’s Center for Biologics Evaluation and Research (CBER), 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 (ORMRR) will answer questions regarding Biologic License Application (BLA) readiness, including how to...
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