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  4. FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing - 02/29/2024
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Webcast

Event Title
FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing
February 29, 2024

Date:
February 29, 2024
Time:
1:00 PM - 2:00 PM ET
Organized By:
Organizer

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, February 29 at 1:00 pm to discuss a recently finalized guidance document on developing human gene therapy products that incorporate human genome editing. This guidance is intended to assist industry members and provide them with recommendations on what to include in an investigational new drug (IND) application, and how best to design, manufacture, and test these products.

FDA CBER Genome Editing Webinar Banner, Thursday, February 29, 2024 1-2pm ET

 

In this webinar, CBER subject matter experts will highlight key considerations in the final guidance. 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, February 29, 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. There will be an opportunity during registration to share a question with the speakers and panelists. 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.

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