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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 sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meetingThe U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease. The age…