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- FDA issues draft guidance to streamline approval of personalized gene therapies and expands CMS access modelThe Food and Drug Administration released a draft guidance that lets a single biologics license application cover multiple variants of a gene‑therapy product. The guidance introduces an Individuali…
- FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patientsThe U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…