1. Gonin, P, Buchholz, CJ, Pallardy, M, Mezzina, M. Gene therapy bio-safety: scientific and regulatory issues. Gene Therapy 2005; 12:S146–S152.
2. Guidance for Industry: Gene Therapy Clinical Trials- Observing Subjects for Delayed Adverse Events (draft), US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, August 2005.
3. US Code of Federal Regulations, Title 21, Part 312, Section 3 (21CFR312.3)
4. Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, February 2000.
5. Good Clinical Practice: Consolidated Guidance (ICH E6), International Conference of Harmonization, June 10, 1996.