Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?
FDA Law Blog
JUNE 23, 2021
In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. Instead, the ultimate clinical benefit must be confirmed in a post-approval study.
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