Current Edition

Providing Regulatory Clarity for Cell- and Gene-based Therapies

Adam Istas, DIA explores how global regulators are responding to dramatic increases in cell and gene-based products in development. Regulators are working to provide further clarity on approval pathways, manufacturing quality standards, and post-approval surveillance of potentially promising therapies. The FDA’s approach is to accelerate the development of cell and gene therapy by working with stakeholders and providing the industry with guidance and regular updates. He identifies proactive efforts by regulators, and the FDA’s leadership in this area as critical to the continued advancement of new therapies.