Key clinical point: NIH and FDA are looking to streamline gene therapy development oversight.
Major finding: The proposal would return the function of the Recombinant DNA Advisory Committee (RAC) to a function more in line with its original mission.
Study details: Full proposal details are to be published in the Federal Register on Aug. 17.
Disclosures: The agency leaders reported no relevant disclosures in the production of the proposal.
Collins FS and Gottlieb S. N Engl J Med. doi : 10.1056/NEJMp1810628
This Week's Must Reads
Must Reads in Gene Therapy
Gene therapy reverses sickle cell phenotype in small study, Esrick EB et al. ASH 2018, Abstract 1023