The FDA recently shared information regarding its flexible approach to overseeing chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies (CGT). Due to the unique nature of the characteristics of CGT, regulatory flexibility must be adapted in a way that encourages increased innovation while still maintaining the integrity of safety and efficacy.
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Welcome and thank you for checking out Cozen O’Connor’s Health Law Informer blog. Health Law Informer will provide updated news and analysis concerning the world of health law. Check back often for new posts and feel free to send us your feedback.
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- FDA Outlines Flexible Requirements to Support Cell and Gene Therapy Innovation
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