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. 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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