FDA’s Human Gene Therapy Draft Guidances: Steps Toward a Modern Framework for the Regulation of Gene Therapy

Alert July 27, 2018

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FDAs Human Gene Therapy Draft Guidances Steps Toward a Modern Framework for the Regulation of Gene Therapy

FDA’s Human Gene Therapy Draft Guidances: Steps Toward a Modern Framework for the Regulation of Gene Therapy

July 27, 2018, Covington Alert

On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.

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