FDA released draft guidance aimed at streamlining approval for certain personalized gene therapies, drawing sharp attention from rare-disease advocates who have criticized prior agency approaches. The draft is framed as clarifying how developers can qualify for a faster review pathway when treatments are individualized for patients. The agency’s move comes as gene therapy developers look for more predictable regulatory routes for one-off and small-cohort programs, particularly in rare genetic diseases. For patients, advocates say the draft guidance provides a clearer commitment that individualized products can move efficiently through the FDA review process. One advocate quoted in the report, Paul Scribner of the PKD Foundation, characterized the effort as a signal to the field that the pathway is a priority. While draft guidance is not final policy, it sets expectations for future submissions and could affect how companies design clinical evidence packages for personalized gene therapies.