Abstract
This chapter provides Office of Cell, Tissue, and Gene Therapy (OCTGT) perspectives on the regulation of adenovirus-based vectors. The first section provides an overview of how these vectors are designed and implications for FDA regulatory oversight. The remaining three sections describe more broadly how the scientific and medical disciplines in OCTGT review submissions for adenoviral vector-based products. This chapter describes general manufacturing requirements for products under Investigational New Drug application, preclinical supporting information needed for initiating clinical studies, and considerations for clinical trial design and for investigators involved in treating patients with adenovirus-based investigational products.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
