483
National Marrow Donor Program IRBFDA 483 - National Marrow Donor Program IRB - April 04, 2023
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Record Details
An FDA inspection of the National Marrow Donor Program IRB in Minneapolis, MN, revealed a significant deficiency in their review procedures. The Institutional Review Board improperly utilized expedited review for changes to previously-approved research protocols that were not minor in nature. This indicates a failure to adhere to appropriate review standards for research modifications.
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ID · bf9c3870-7d31-4559-85c4-8c293e741e77