FDA turns focus on biologics in spate of warning letters

On December 1, the US Food and Drug Administration (FDA) issued a spate of warning letters to drug and biologic manufacturers for marketing unapproved products.

All three letter recipients – BioXtek, Celularity, and Lux Therapeutics – are manufacturers that utilize human cells, tissues, and cellular and tissue-based products (HCT/Ps) in the

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