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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 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…