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The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Wednesday, August 30, 2023 to answer stakeholder questions related to nonclinical assessment of cell and gene therapy products. Experts from OTP’s Office of Pharmacology/Toxicology will be on-hand to answer questions.

Focus for This Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products

Nonclinical studies are an important part of medical product development and inform regulatory decisions. The data from nonclinical studies provide information on the safety and activity profile of an investigational product and guide the design of early-phase clinical trials. For more information, see the 2013 FDA guidance document for recommendations on the substance and scope of nonclinical information needed to support clinical trials for investigational cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation, and certain biologic-device combination products. 

Meeting Logistics

• Date: Wednesday, August 30, 2023
• Time: 11:30 a.m.–1:00 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 the registration process. Please submit questions by July 21, 2023. 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 or drug applications 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.