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- FDA releases draft guidance on oversight of individualized gene-editing productsThe U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
- FDA releases details on accelerated approval process for personalized gene therapiesThe U.S. Food and Drug Administration has issued additional guidance on a faster approval pathway designed for personalized gene therapies. The new details outline how sponsors can seek expedited r…