Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases

doi:10.2215/CJN.02790319

. 2019 Oct 7;14(10):1531-1532.

doi: 10.2215/CJN.02790319. Epub 2019 Sep 6.

Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases

Aliza M Thompson¹, Mary Ross Southworth

Affiliations

PMID: 31492691
PMCID: PMC6777582
DOI: 10.2215/CJN.02790319

Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases

Aliza M Thompson et al. Clin J Am Soc Nephrol. 2019.

. 2019 Oct 7;14(10):1531-1532.

doi: 10.2215/CJN.02790319. Epub 2019 Sep 6.

Authors

Aliza M Thompson¹, Mary Ross Southworth

Affiliation

¹ Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

PMID: 31492691
PMCID: PMC6777582
DOI: 10.2215/CJN.02790319

No abstract available

Keywords: Drug Approval; kidney diseases; real-world evidence.

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References

1. US Food and Drug Administration: Framework for FDA’s Real-World Evidence Program. Available at: https://www.fda.gov/media/120060/download. Accessed August 13, 2019
1. Flythe J, Narendra J, Hilliard T, Frazier K, Ikeler K, Amolegbe A, Mitchell D, Dorough A, Lee SY, Ordish A, Wilkie C, Dember L; Building Research Capacity in the Dialysis Community at the Local Level Stakeholder Workshop Participants: Cultivating a research-ready dialysis community [published online ahead of print February 8, 2019]. J Am Soc Nephrol doi: 10.1681/ASN.2018101059 - DOI - PMC - PubMed

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[1] US Food and Drug Administration: Framework for FDA’s Real-World Evidence Program. Available at: https://www.fda.gov/media/120060/download. Accessed August 13, 2019

[2] US Food and Drug Administration: Framework for FDA’s Real-World Evidence Program. Available at: https://www.fda.gov/media/120060/download. Accessed August 13, 2019

[3] Flythe J, Narendra J, Hilliard T, Frazier K, Ikeler K, Amolegbe A, Mitchell D, Dorough A, Lee SY, Ordish A, Wilkie C, Dember L; Building Research Capacity in the Dialysis Community at the Local Level Stakeholder Workshop Participants: Cultivating a research-ready dialysis community [published online ahead of print February 8, 2019]. J Am Soc Nephrol doi: 10.1681/ASN.2018101059 - DOI - PMC - PubMed

[4] Flythe J, Narendra J, Hilliard T, Frazier K, Ikeler K, Amolegbe A, Mitchell D, Dorough A, Lee SY, Ordish A, Wilkie C, Dember L; Building Research Capacity in the Dialysis Community at the Local Level Stakeholder Workshop Participants: Cultivating a research-ready dialysis community [published online ahead of print February 8, 2019]. J Am Soc Nephrol doi: 10.1681/ASN.2018101059 - DOI - PMC - PubMed

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Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases

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Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases

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