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Analysis

FDA Faces Fresh Drug-Device Headaches After DC Circ. Loss

By Adam Lidgett ( April 20, 2021, 8:30 PM EDT) -- A new D.C. Circuit ruling will make it harder for the U.S. Food and Drug Administration to treat products as drugs when they fit into overlapping definitions of drugs and medical devices, experts say, or at least force the agency to be more careful about how it designates such products....

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