Speaking to Alliance for Regenerative Medicine (ARM) board members at what he called a "key point" in the ascendancy of cell and gene therapies, FDA Commissioner Scott Gottlieb said his agency is working to address a number of challenges facing the nascent field. New guidance documents that will articulate a framework for the manufacturing and clinical development of gene therapies are already underway, he said, including the outline of potential accelerated approval endpoints for certain therapies.