February 28, 2019

GENUS MEDICAL TECHNOLOGIES LLC v. UNITED STATES FOOD AND DRUG ADMINISTRATION

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Reflects complaints, answers, motions, orders and trial notes entered from Jan. 1, 2011.
Additional or older documents may be available in Pacer.


Coverage

  1. December 06, 2019

    Judge Says FDA Can't Regulate Imaging Liquid As Drug

    Congress didn't give the U.S. Food and Drug Administration the discretion to treat any diagnostic medical device as a drug, a D.C. federal judge ruled Friday, handing a win to a company challenging the agency's classification of its product used in medical imaging.


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