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Outsourcing Facilities Association (OFA): The OFA believes the FDAs resolution of the tirzepatide shortage was reckless and arbitrary. They accuse the FDA of ignoring evidence that the shortage persists and resolving it with only a post to its website, depriving patients of much needed treatment and artificially raising drug prices. The complaint continues that the way the FDA proceeded was in violation of the Administrative Procedure Act (APA), which should have guided the FDA to give notice of its action in the Federal Register, solicit comments from interested parties, and address meaningful comments with rationale before resolving the shortage

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These changes appear repeatedly in structured trials

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2025;10:e10711