FDA sets the stage for further gene therapies

12 July 2018

Having last year announced its comprehensive policy framework for regenerative medicine, the US Food and Drug Administration (FDA) has this week unveiling complementary measures for the development, review and approval of gene therapies.

This comes after a 12-month period in which the FDA has approved three separate gene therapies, and more are being studied in areas including genetic disorders, autoimmune diseases, heart disease, cancer and HIV.

Scott Gottlieb, the FDA Commissioner, has published a statement, accepting that the framework constructed for how these products should be developed, reviewed by regulators, and reimbursed, will help set the stage for the continued advancement of this new market.

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