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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

it is not established using a validated surrogate endpoint that would support traditional approval, e.g., FEV1 in asthma or serum LDL in hypercholesterolemia). Latest FDLI Update Magazine Features Interview Conducted by HP&M’s James Valentine on Patient Engagement in Drug Development (May 3, 2017).