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In its lawsuit, the OFA said that the FDA’s decision to end the shortage was a “reckless” and “arbitrary” move and could “deprive patients of a vital treatment for type 2 diabetes and obesity.” In an interview with BioSpace last month, David Rosen, partner at Foley & Lardner, said that the lawsuit “is a precedent in this area.” Prior to the OFA suit, “no one has ever challenged the FDA’s decision to remove a therapy from the drug shortage list.” The OFA case is still ongoing, with the next court update due on Thursday
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Arch Biochem Biophys 525: 102-110
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