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- FDA issues draft guidance to streamline approval of personalized gene therapiesThe FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines. The new framework is intended to speed the development and approval of personalized gene t…
- FDA issues final guidance on potency standards for cell and gene therapy developersThe U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…