- March 7, 2024
- 1:00 PM - 2:00 PM ET
- Organized By:
The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting 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 will highlight key considerations in the final guidance and address manufacturing, nonclinical, and clinical considerations specific to CAR T cell products. Registrants can submit questions in advance during the registration process.
Meeting Information and Registration
This event is free and open to the public. However, registration is required. Please see the link below to register.
- Date: Thursday, March 7, 2024
- Time: 1:00 p.m. - 2:00 p.m. ET
- Location: The webinar will be held via Zoom.
Please register for the webinar now. Please note, there will not be an option to ask live questions during this event. However, there will be an opportunity to share questions with the speakers and panelists during registration. The deadline to submit questions via registration is February 13, 2024. A recording and other relevant meeting materials will be posted online following the event.
Please note, the FDA is not able to comment on or answer questions regarding specific investigational products or drug applications during this event. Further, questions considered inappropriate or out of scope for the event will not be addressed.
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.