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.

Related Keywords

San Francisco ,California ,United States ,Switzerland ,Singapore ,Israel ,Canada ,United Kingdom ,Brazil ,Australia ,Japan ,America ,Peter Marks ,Mark Jan ,Solution Through International Collaboration ,Alliance For Regenerative Medicine ,Office Of Tissues ,Office Of Therapeutic Products ,Oncology Center ,International Council For Harmonisation ,European Union ,Drug Administration ,World Health Organization ,Readiness Pilot Program ,Go To Guide ,Gene Therapies Global Pilot ,Cogent Global ,Oncology Excellence ,Project Orbis ,International Council ,Biologics Evaluation ,Advanced Therapies ,Therapeutic Products ,Commercial Success ,National Institutes ,Bespoke Gene Therapy ,Drug Omnibus Reform Act Section ,Investigational New Drug ,Director Mark ,Regenerative Medicine ,Gene Therapy State ,Industry Briefing , ,