Human Gene Therapy for Neurodegenerative Diseases

On 21 October 2022 the FDA published the final guidance on developing human gene therapy for neurodegenerative diseases.

This guidance provides recommendations to sponsors developing human gene therapy (GT) products for neurodegenerative diseases affecting adult and pediatric patients. This guidance focuses on considerations for product development, preclinical testing, and clinical trial design.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /