1. Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications: Guidance for Industry,2020
2. National Institutes of Health. Novel and Exceptional Technology and Research Advisory Committee https://osp.od.nih.gov/biotechnology/main-nextrac/.
3. The Next Phase of Human Gene-Therapy Oversight;Collins;N. Engl. J. Med.,2018
4. Guidance Document. Expedited Programs for Serious Conditions – Drugs and Biologics,2014
5. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. Guidance for Industry,2019