These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
4. Quality Assessment and Production of Human Cells for Clinical Use. Fraser L; Bruce K; Campbell JM; De Sousa PA Methods Mol Biol; 2018; 1780():607-629. PubMed ID: 29856038 [TBL] [Abstract][Full Text] [Related]
5. Concise review: making and using clinically compliant pluripotent stem cell lines. Carpenter MK; Rao MS Stem Cells Transl Med; 2015 Apr; 4(4):381-8. PubMed ID: 25722426 [TBL] [Abstract][Full Text] [Related]
6. Considerations on chemistry, manufacturing, and control of stem cell products for Investigational New Drug application in China. Lu J; Wei W Biologicals; 2020 Nov; 68():3-8. PubMed ID: 33097376 [TBL] [Abstract][Full Text] [Related]
7. United States Food and Drug Administration Regulation of Gene and Cell Therapies. Bailey AM; Arcidiacono J; Benton KA; Taraporewala Z; Winitsky S Adv Exp Med Biol; 2015; 871():1-29. PubMed ID: 26374210 [TBL] [Abstract][Full Text] [Related]
8. Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon. Mendicino M; Fan Y; Griffin D; Gunter KC; Nichols K Cytotherapy; 2019 Jul; 21(7):699-724. PubMed ID: 31196820 [TBL] [Abstract][Full Text] [Related]
9. Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies. Abbasalizadeh S; Baharvand H Biotechnol Adv; 2013 Dec; 31(8):1600-23. PubMed ID: 23962714 [TBL] [Abstract][Full Text] [Related]
10. Regulatory considerations in application of encapsulated cell therapies. van Zanten J; de Vos P Adv Exp Med Biol; 2010; 670():31-7. PubMed ID: 20384216 [TBL] [Abstract][Full Text] [Related]
11. The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis. Knoepfler PS; Turner LG Regen Med; 2018 Jan; 13(1):19-27. PubMed ID: 29327974 [TBL] [Abstract][Full Text] [Related]
12. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium. Allison G; Cain YT; Cooney C; Garcia T; Bizjak TG; Holte O; Jagota N; Komas B; Korakianiti E; Kourti D; Madurawe R; Morefield E; Montgomery F; Nasr M; Randolph W; Robert JL; Rudd D; Zezza D J Pharm Sci; 2015 Mar; 104(3):803-12. PubMed ID: 25830179 [TBL] [Abstract][Full Text] [Related]
13. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy. Pinkerton JV; Pickar JH Menopause; 2016 Feb; 23(2):215-23. PubMed ID: 26418479 [TBL] [Abstract][Full Text] [Related]
14. Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective. Hussong D AAPS PharmSciTech; 2010 Sep; 11(3):1482-4. PubMed ID: 20845091 [TBL] [Abstract][Full Text] [Related]
15. Pluripotent stem cells in translation: a Food and Drug Administration-National Institutes of Health collaboration. Kleitman N; Rao MS; Owens DF Stem Cells Transl Med; 2013 Jul; 2(7):483-7. PubMed ID: 23757505 [TBL] [Abstract][Full Text] [Related]