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The FDAs reluctance to weigh in on this has been discussed in the litigation before when plaintiffs opposed Johnson & Johnsons motion to dismiss the lawsuit

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American Journal of Gastroenterology, 119(1 Suppl), S4397S4398

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The Academy assists by coordinating with its College and Chapters for Nomination of the IME

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503A pharmacies lost their shortage-based enforcement discretion in April 2025

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