Gene Therapy Policies Can Strike An Ethical Balance

Law360 (May 3, 2019, 3:05 PM EDT) -- On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy.

The FDA’s message is clear: Gene therapy is a useful technique in dealing with some of the most serious diseases faced by humans, and the FDA is working toward supporting...

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