The Next Phase of Human Gene-Therapy Oversight

New England Journal of Medicine
October 11, 2018   Vol. 379 No. 15

The Next Phase of Human Gene-Therapy Oversight
Francis S. Collins, M.D., Ph.D., and Scott Gottlieb, M.D.
As gene therapy continues to change, so must the federal framework set up to oversee it. As new biotechnologies continue to emerge, the NIH and the FDA are proposing reductions in duplicative oversight and changes to the role of the Recombinant DNA Advisory Committee.