Abstract

Keywords
Get full access to this article
View all access options for this article.
References
1.21st Century Cures Act . https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/default.htm. Accessed May 21, 2018 .
2.Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use . Guidance for industry and Food and Drug Administration staff . https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585403.pdf. Accessed May 21, 2018 .
3.Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception . Guidance for industry . https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM419926.pdf. Accessed May 21, 2018 .
4.US Food and Drug Administration . FDA announces comprehensive regenerative medicine policy framework: framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy . https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm. Accessed May 21, 2018 .
5.US Food and Drug Administration . FDA seeks permanent injunctions against two stem cell clinics . https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm?utm_campaign=FDA%20seeks%20permanent%20injunctions%20against%20two%20stem%20cell%20clinics&utm_medium=email&utm_source=Eloqua. Accessed May 21, 2018 .
