TL;DR
For people with a rare inherited disease, a gene fix built for their own mutation has so far been a one-off rescue, needing its own full approval file for every patient. On Oct. 27 the FDA drafted a way around that: one license could cover many custom versions of the same gene editor, and a new version for a new patient would count as a manufacturing change rather than a new drug. If the idea survives into final rules, a company could keep a standing catalogue of editors and add patients the way a factory adds a new size. The draft is narrow, covering only inherited diseases caused by one known gene, and it says nothing yet about how such drugs must be tested.
Below the line, for paid subscribers: The full story: where it stands, how we got here and what's dated next; our Odds board on 5 milestones, starting with "The FDA licenses a gene editor that covers many patient-specific versions for a rare inherited disease by 2030"; our labeled speculation on what it adds up to; and every source.