The FDA has unveiled draft guidance aimed at enabling approvals for “plug and play” personalized gene therapies for rare diseases. The proposal targets treatments that correct different mutations within the same disease-causing gene, a strategy meant to reduce the need for separate full clinical programs when traditional trials are impractical. Under the plan, a sponsor could pursue approval for a specific personalized therapy for one mutation using more conventional clinical evidence, then later seek clearance for additional mutations using laboratory data instead of repeating whole clinical studies. The FDA would define the allowed later approvals through an “individualized feature space” described in the initial application. The draft framework lands as regulators push a broader Rare Disease Framework Initiative and hold a public meeting to discuss standards for developing therapies by condition rather than using one-size-fits-all approaches. Analyst Joseph Thome of TD Cowen called the optionality “plug and play.”