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

Author:

Gnanasakthy AriORCID,Qin Shanshan,Norcross Lindsey

Publisher

Springer Science and Business Media LLC

Subject

General Engineering

Reference7 articles.

1. Perfetto EM, Burke L, Oehrlein EM, Epstein RS. Patient-focused drug development: a new direction for collaboration. Med Care. 2015;53(1):9–17. https://doi.org/10.1097/MLR.0000000000000273.

2. 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed 7 July 2021

3. 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.

4. 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.

5. 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: methods to identify what is important to patients guidance for industry, food and drug administration staff, and other stakeholders. 2022. https://www.fda.gov/media/131230/download. Accessed 16 Sept 2022.

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