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  4. OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products - 06/04/2026
  1. News & Events (Biologics)

Workshop | Virtual

Event Title
OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
June 4, 2026

Date:
June 4, 2026
Time:
11:00 a.m. - 12:00 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) hosted a virtual town hall on June 4, 2026. During this town hall, experts from OTP’s Office of Review Management & Regulatory Review (ORMRR) answered 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.

Focus for This Town Hall

A BLA is a request for permission to introduce, or deliver for introduction, a biologic product, such as a cell or gene therapy, into interstate commerce (21 CFR 601.2). A BLA must contain comprehensive data from preclinical and clinical studies and detailed information about manufacturing processes and facilities, demonstrating the product's safety, purity, and potency. Prior to submission, sponsors may request a pre-BLA meeting with OTP to discuss the planned content of the marketing application. Learn more about the original BLA process in this OTP Learn resource, including BLA review timelines, filing procedures, and regulatory actions.

About the OTP Town Hall Series

OTP launched its virtual town hall series to engage with product developers and researchers and discuss topics related to OTP-regulated products. The town halls have a question-and-answer format with the goal of providing regulatory information to advance drug development. Learn more about OTP and view recordings from our previous town hall events.

Resources for You

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