Shorter Gene Therapy Postmarket Studies ‘On The Table’

Amid complaints about the challenges of following gene therapy patients for up to 15 years, OTP Director Nicole Verdun said the FDA is considering how to conduct long-term postmarket studies more efficiently.

Natural history or other data could help the FDA shorten gene therapy follow-up times. (Shutterstock)

Upcoming cell and gene therapy guidance could adjust the challenging requirement for up to 15 years of postmarket follow-up and potentially further streamline product development.

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