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2 United States Renal Data System, 2020 USRDS Annual Data Report, https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
3 https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease
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6 ISN GKH Atlas, 2019
7 United States Renal Data System, 2020 USRDS Annual Data Report, https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
8 National Kidney Foundation, https://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats
9 United States Renal Data System, 2020 USRDS Annual Data Report, https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
10 Kidney International (2020) 97, 226-232
11 United States Renal Data System, 2020 USRDS Annual Data Report, https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
12 https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease
13 ISN GKH Atlas, 2019
14 United States Renal Data System, 2020 USRDS Annual Data Report, https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
15 The Kidney Project, "Statistics," https://pharm.ucsf.edu/kidney/need/statistics
16 ISN GKH Atlas, 2019
17 ISN GKH Atlas, 2019
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22 www.cjasn.org Vol 14 October 2019 A Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies A Catalyst for Change Joseph V. Bonventre et al
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25 United States Renal Data System, 2020 USRDS Annual Data Report, https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
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30 Nature Reviews Nephrology, volume 16, pages 546-547(2020)
31 If the most important therapeutic action cannot be determined (e.g., a combination product may have two independent modes of action, neither of which is subordinate to the other) an algorithm (see FDA's regulations at 21 CFR Part 3) directs center assignment based on which center regulates combination products that raise similar types of safety and effectiveness questions, or, if there is no such center, based on which center has the most expertise to evaluate the most significant safety and effectiveness questions raised by the combination product.
32 For a description of which categories of products are reviewed and regulated by CBER versus CDER, please refer to the Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and Research
33 For more information, see "Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff" at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM374432.pdf.
35 Cabral, B. et al. "Probing expert opinions on the future of kidney replacement therapies." Artificial Organs. 2020;00:1-9.
36 Wierenga, F. and Sheldon, M. "The Kidney Health Initiative innovation roadmap for renal replacement therapies: Building the yellow brick road, while updating the map" Artificial Organs. 2020; 44:111-122.