The use of CRISPR-Cas9 gene editing technology has potential to transform the field of gene therapy through its simple and cost-effective delivery mechanism, said Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), during a 23 April webinar sponsored by the Alliance for a Stronger FDA. He also addressed FDA’s forthcoming guidance on accelerated approval for gene therapies for treating rare diseases.
Marks also said that FDA needs to develop an agency-wide remote work policy. Currently, different centers within FDA have different policies in this area, he said. “We cannot have different centers in the agency have different human resource polices.” He added that “if we don’t have our medical product centers having similar policies this will lead to too much movement within the agency.”…
