Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Feds move to streamline oversight of gene therapy

Collins FS and Gottlieb S. N Engl J Med. doi: 10.1056/NEJMp1810628

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.

Read the article.


Collins FS and Gottlieb S. N Engl J Med. doi : 10.1056/NEJMp1810628