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FDA fast track for one-patient gene therapies.

1 report so far. New developments are added to this thread as they happen.

  1. Oct 27, 2026
    DRAFT RULES FOR A QUICKER PATH FOR CUSTOM GENE THERAPYFDA draft guidance

    FDA drafts a quicker path to approval for some custom gene therapies

    The FDA published draft rules that would speed approval of some gene therapies made for very small groups of patients. Rare disease advocates welcomed the move, but the plan is not final.