In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs.
Recently, the FDA lost its bid in federal court to retain the discretion to classify some imaging agents as drugs, even when they meet the definition of a device. This ruling has provoked continuing objections from both pharma and medical device industry players, as companies would be faced with the challenges to switch from drug good manufacturing practices (GMPs) to the quality systems regulations that apply to medical devices.
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