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Dear CDER COA Qualification Program Stakeholders, We are excited to announce that the U.S. Food and Drug Administration (FDA) qualified Drug Development Tool (DDT) COA #000015: PROMIS Fatigue Short Form 10a on May 20, 2026, to support clinical trials of investigational therapies for patients with rheumatoid arthritis (RA). The PROMIS Fatigue Short Form 10a total score measures RA-related fatigue severity, and additional information can be found on the CDER & CBER DDT Qualification Project Search database. If you have any questions, please feel free to email COADDTQualification@fda.hhs.gov.
Kind Regards, The CDER COAQP Center for Drug Evaluation and Research Clinical Outcome Assessment Qualification Program (CDER COAQP)
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