Stay updated with breaking news from Vanilla Silq. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any...
ADVERTISEMENT ADVERTISEMENT FDA Faces Fresh Drug-Device Headaches After DC Circ. Loss Law360 (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. In a majority panel ruling authored by U.S. Circuit Judge Karen L. Henderson, the appellate court on Friday affirmed a D.C. federal judge's order granting summary judgment to Genus Med...