Business · 30/01/2024Updated: 10/17/2026 · 1 min read
FDA Announces Final Guidance on Human Gene Therapy Products with Genome Editing
The FDA has released a final guidance document outlining recommendations for sponsors developing human gene therapy products that incorporate genome editing, covering aspects such as IND application information, product design, and clinical trial design.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →