journal article Open Access May 03, 2022

Real‐world data: Assessing electronic health records and medical claims data to support regulatory decision‐making for drug and biological products

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References
15
[1]
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) and Oncology Center for Excellence (OCE). Real‐World Data: Assessing electronic health records and medical claims to support regulatory decision‐making for drug and biological products: Guidance for Industry Draft Guidance. Sept2021.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/real‐world‐data‐assessing‐electronic‐health‐records‐and‐medical‐claims‐data‐support‐regulatory.
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DanielG SilcoxC BryanJ McClellanM RomineM FrankK.Characterizing RWD quality and relevancy for regulatory purposes. Duke‐Margolis Center for Health Policy. Retrieved October 01 2018.https://healthpolicy.duke.edu/sites/default/files/atoms/files/characterizing_rwd.pdf.
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https://www.sentinelinitiative.org. Accessed Oct 3 2021.
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Published
May 03, 2022
Vol/Issue
31(7)
Pages
717-720
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Cite This Article
Cynthia J. Girman, Mary E. Ritchey, Vincent Lo Re (2022). Real‐world data: Assessing electronic health records and medical claims data to support regulatory decision‐making for drug and biological products. Pharmacoepidemiology and Drug Safety, 31(7), 717-720. https://doi.org/10.1002/pds.5444