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Home » Gene Therapy Trials for Neurodegenerative Diseases Should Start With Adults, Guidance Says
Gene Therapy Trials for Neurodegenerative Diseases Should Start With Adults, Guidance Says
Sponsors of human gene therapy (GT) products for neurodegenerative diseases affecting adults and children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week. When pediatric trials must be conducted first, sponsors should provide a rationale for why adult studies are not ethical or feasible, the guidance says.