483
SpringWorks Therapeutics, Inc.SpringWorks Therapeutics, Inc. – FDA 483, Mar 31, 2023
Record Details
An FDA inspection of SpringWorks Therapeutics, Inc. in Durham, NC, revealed a significant issue with their clinical study conduct. The firm failed to ensure the study adhered to its protocol and investigational plan. Specifically, new tumors were incorrectly included in the calculation of target tumor sums, deviating from the Statistical Analysis Plan.
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ID · 2ad46515-ca44-4ca6-b051-dc668d7ae375
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