Webcast | Virtual
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:
The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted 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.
In this webinar, CBER subject matter experts highlighted key considerations in the final guidance.
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: Human Gene Therapy Products Incorporating Human Genome Editing | pdf (303.89 KB) |