Webcast | Virtual
Event Title
FDA CBER Webinar: Considerations for the Development of CAR T Cell Products
March 7, 2024
- Date:
- March 7, 2024
- Time:
- 1:00 PM - 2:00 PM ET
- Organized By:
The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public webinar on Thursday, March 7 at 1:00 p.m. to discuss a recently finalized guidance document on considerations for the development of Chimeric Antigen Receptor (CAR) T cell products. This guidance is intended to assist industry and academic sponsors that are developing ex vivo-manufactured CAR T cell products.
In this webinar, CBER subject matter experts highlighted key considerations in the final guidance and addressed manufacturing, nonclinical, and clinical considerations specific to CAR T cell products.
About FDA CBER OTP
FDA CBER OTP oversees development for a wide variety of biological products, including gene and cell therapies, tissues and tissue engineering products, xenogeneic products, and more. OTP strives to lead all regulatory decisions with data, impartiality, and compassion and always welcomes the participation of patients and their advocates in formal meetings related to the development of investigational products. Learn more about OTP and view information on other meetings and workshops.
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Event Materials
| Title | File Type/Size |
|---|---|
| FDA CBER Webinar Transcript: Considerations for the Development of CAR T Cell Products – March 7, 2024 | pdf (301.10 KB) |