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The FDA's Overreaction to the Tofa Trial
The FDA released a draft guidance document that talked about labeling. It said they were now going to label for theoretical off label possible uses, and also what might be the impact of the product if you had a pandemic. That may help to explain why the label for Tofa based on oral surveillance was now applied to both barisitinib and upatisitinib. But it's also been applied to all the JACS in dermatologic indications and hematologic indications, except for the requirement to fail a TNF inhibitor first.