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News: FDA finalizes new drafted guidance for 6 gene therapy

The U.S. Food and Drug Administration (FDA) has finalized a set of 6 new guidance documents for the gene therapy development and other new draft guidance that interprets close relativity in the gene therapies under the orphan drug regulations.

The guidance has come into light after 900 investigational and more new drug applications have been under process for gene and cell therapy clinical studies, and new experts were hired by the FDA to tackle the related challenges.