FDA Cell and Gene Therapy Listening Session Highlights Regulatory Outlook

The U.S. FDA convened a public listening session engaging industry experts from GeneVentiv Therapeutics, Viralgen, and others to discuss leveraging prior knowledge for accelerated cell and gene therapy (CGT) product development and regulatory review. The dialogue focused on regulatory pathways, scientific challenges, and collaboration opportunities to streamline approval and commercialization processes. The session reflects evolving regulatory dynamics supporting innovation in CGT modalities.