CPC Comments on FDA’s Draft Guidance “Human Gene Therapy for Neurodegenerative Diseases”

On April 6, 2021, the CPC filed a comment letter on FDA’s draft guidance “Human Gene Therapy for Neurodegenerative Diseases.” The CPC appreciates FDA’s efforts to provide additional guidance for delivery devices used with human gene therapy products, but offers certain recommendations regarding the delivery device-related expectations described in the draft guidance.  Overall, these comments suggest that FDA pursue a more flexible approach with regard to sponsors’ use of delivery devices.