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Town Hall | Virtual

Event Title
OTP Town Hall: CMC Readiness for Gene Therapy BLAs
June 4, 2024

Scheduled
Date:
June 4, 2024
Time:
11:00 AM - 12:30 PM ET

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Experts from OTP’s Office of Gene Therapy CMC will be on hand to answer questions.

Focus for This Town Hall: Gene Therapy BLA CMC Readiness

The FDA requires sponsors to provide CMC information as part of investigational new drug, biologics license, and new drug applications. For gene therapies and other biologic products, the CMC information should describe the sponsor’s commitment to perform manufacturing and testing to assure product safety, identity, quality, purity, and strength (including potency). The focus of this virtual town hall is to answer questions related to CMC data and information needed to support pre-BLA meetings or original BLA submissions, including the commercial manufacturing process, product comparability (if applicable), stability data, and more. For more information, please view materials from previous town halls on gene therapy CMC. 

Meeting Logistics

  • Date: Tuesday, June 4, 2024
  • Time: 11:00 a.m. to 12:30 p.m. ET
  • Location: The webinar will be held via Zoom.
  • Registration: Registration is required. Please register for the event now.

Submit a Question

Questions can be submitted during registration. Please submit questions by May 13, 2024. Attendees will also be able to submit questions during the live event.

Please note, the FDA is not able to comment on or answer questions regarding specific investigational products, biologics applications, or draft guidance documents during the town hall. Further, questions considered inappropriate or out of scope for the event will not be addressed.

About the OTP Town Hall Series

OTP launched its virtual town hall series to engage with product development stakeholders 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 stakeholders to advance drug development. Learn more about OTP and view recordings from our previous town hall events.

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