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FDA's CBER Issues Final Guidance For CAR T Cell Products

FDA's CBER Issues Final Guidance For CAR T Cell Products
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FDA Takes First Step Toward International Regulation of Gene Therapies to Treat Rare Diseases | Insights

In a groundbreaking development, on Jan. 8, 2024, the U.S. Food and Drug Administration (FDA) announced a pilot program called Collaboration on Gene Therapies Global Pilot to ensure its leadership in the regulation of cell and gene therapy, and to secure the U.S. market as the most prominent place for development of novel therapies.

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FDA's CoGenT Global Revolutionizing Gene Therapy Regulations

FDA's CoGenT Global Revolutionizing Gene Therapy Regulations
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FDA warns of secondary cancer risk tied to CAR-T therapies that treat cancer

The US Food and Drug Administration has issued a new warning about the possible risk of secondary cancers in cancer patients who have been treated with a form of immunotherapy

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FDA warns of secondary cancer risk tied to CAR-T therapies that treat cancer

FDA warns of secondary cancer risk tied to CAR-T therapies that treat cancer
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