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The implication is that companies should treat this letter as a clear guide to compliant AI use: human review, qualified reviewer, documented approval, traceable record is now explicitly FDAs expectation for AI workflows ( [48] )

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This blog post will predict key issues faced by plaintiffs pursuing claims in the ongoing multidistrict litigation against manufacturers of these drugs, and will argue that courts should recognize an exception to the learned intermediary doctrine for GLP-1 RA drugs

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