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- FDA issues final guidance on potency assurance for cell and gene therapy manufacturersThe FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
- FDA issues draft guidance to streamline approval of personalized gene therapiesThe FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines.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…