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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Specifically, β€œit would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting.” The device labeling specifically mentioned it. And lost again on appeal in Cates.

FDA 105