Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?
FDA Law Blog
JUNE 23, 2021
I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.
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