Monday - November 2, 2026
FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality
November 02, 2026
WASHINGTON, Nov. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following news release:

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FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality

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FDA issues final guidance for cell and gene therapy manufacturers, recommends building potency assurance into every stage of a therapy's lifecycle -- from early development through patient delivery

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