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Editorial
. 2023 Jan;16(1):3-5.
doi: 10.1007/s40271-022-00607-6. Epub 2022 Oct 19.

FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?

Ari Gnanasakthy  1 , Shanshan Qin  2 , Lindsey Norcross  2
Affiliations
Editorial

FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?

Ari Gnanasakthy et al. Patient. 2023 Jan.
No abstract available

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References

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    1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. Guidance for industry: patient-reported outcomes measures: use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati... . Accessed 7 July 2021
    1. Mullin T, Vaidya P, Chalasani M. Recent US food and drug administration efforts to integrate the patient’s perspective in drug development and decision making. Clin Pharmacol Ther. 2019;105(4):789–91. https://doi.org/10.1002/cpt.1290 . - DOI
    1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Reserach, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. Patient-focused drug development: collecting comprehensive and representative input: guidance for industry, food and drug administration staff , and other stakeholders. 2020. https://www.fda.gov/media/139088/download . Accessed 16 Sept 2022.
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