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. 2022 Jul;31(7):717-720.
doi: 10.1002/pds.5444. Epub 2022 May 3.

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

Cynthia J Girman  1 , Mary E Ritchey  1   2   3 , Vincent Lo Re 3rd  4
Affiliations

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

Cynthia J Girman et al. Pharmacoepidemiol Drug Saf. 2022 Jul.
No abstract available

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References

    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and medical claims to support regulatory decision‐making for drug and biological products: Guidance for Industry, Draft Guidance. Sept 2021. https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents....
    1. Daniel G, Silcox C, Bryan J, McClellan M, Romine M, Frank K. 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/characteri....
    1. Girman CJ, Ritchey ME, Zhou W, Dreyer NA. Considerations in characterizing real‐world data relevance and quality for regulatory purposes: a commentary. Pharmacoepidemiol Drug Saf. 2019;28(4):439‐442. doi:10.1002/pdf.4697 - DOI - PMC - PubMed
    1. Ritchey ME, Girman CJ. Evaluating the feasibility of electronic health records and claims data sources for specific research purposes. Ther Innov Reg Sci. 2020;54:1296‐1302. doi:10.1007/s43441-020-00139-x - DOI - PubMed
    1. Wang SV, Patterson OV, Gagne JJ, et al. Transparent reporting on research using unstructured electronic health record data to generate ‘real world’ evidence of comparative effectiveness and safety. Drug Saf. 2019;42(11):1297‐1309. - PubMed

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