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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On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.
March 22, 2020, Covington Alert
The U.S. Food and Drug Administration (FDA) released guidance on March 19, 2020 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” (Guidance). The Guidance revises FDA’s February 2012 final guidance for industry on adverse event reporting during an influenza pandemic to clarify that the guidance ...
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...
November 7, 2017, Covington Alert
On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.