Early experience with the FDA's regulatory review of novel gene therapies

Affiliations

• ¹ Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA jeremy.puthumana@yale.edu.
• ² Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.
• ³ Yale National Clinician Scholars Program, Yale School of Medicine, New Haven, Connecticut, USA.
• ⁴ Division of Health Care Delivery Research, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA.
• ⁵ Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.