FDA Takes First Step Toward International Regulation of Gene Therapies to Treat Rare Diseases | Insights
In a groundbreaking development, on Jan. 8, 2024, the U.S. Food and Drug Administration (FDA) announced a pilot program called Collaboration on Gene Therapies Global Pilot to ensure its leadership in the regulation of cell and gene therapy, and to secure the U.S. market as the most prominent place for development of novel therapies.
Source: gtlaw.com