Town Hall | Virtual
Event Title
OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products
August 30, 2023
- Date:
- August 30, 2023
- Time:
- 11:30 AM - 1:00 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a 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 were available 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.
View the August 2023 recording for the OTP Town Hall on Nonclinical Assessment of Cell and Gene Therapy Products.
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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Event Materials
| Title | File Type/Size |
|---|---|
| Transcript - OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products - August 30, 2023 | pdf (399.71 KB) |