Reference
- Title 21 of the Code of Federal Regulations Part 600.3(s)
Websites
- Assaying Potency of Novel Vaccines. www.niaid.nih.gov/daids/vaccine/novel_vaccines.htm
- International Conference on Harmonisation Q6B Guidance document. ‘Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products’ Federal Register 64FR:44928 (1999). www.ich.org/LOB/media/MEDIA432.pdf
- Transcript of Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee of the FDA. February 9, (2006). www.fda.gov/ohrms/dockets/ac/06/transcripts/2006–4205T1.pdf