In a videoconference Thursday with the Executive Committee of the Alliance for Regenerative Medicine (ARM), the FDA’s Dr. Peter Marks reiterated the agency’s continued commitment to gene therapy, and explained that there have been no changes to FDA’s policies or approaches to gene therapies. The FDA remains focused on safety and efficacy in its evaluations of potentially transformative cell and gene therapies. ARM and its 360+ members remain bullish about the promising pipeline of advanced therapies that seek to treat, and possibly cure, a wide range of debilitating diseases and conditions. The FDA in January 2019 stated that, by 2025, it expects to approve between 10 and 20 gene and cell therapies each year.
