1. United States FDA Regulatory Information: Legislation.
http://www.fda.gov/RegulatoryInformation/default/htm
2. United States Code of Federal Regulations, Title 21.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
3. Guidance for Industry: CGMP for Phase 1 Investigational Drugs (2008).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf
4. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products (2013).
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm376136.htm
5. United States FDA Cellular and Gene Therapy Guidances.
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/default.htm