Regulatory considerations for gene-therapy strategies and products.
Wivel
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Department of Health and Human Services, National Institutes of Health, Bethesda, MD 20892.
D015316:Genetic Therapy / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D009316:National Institutes of Health (U.S.); D014481:United States; D014486:United States Food and Drug Administration