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Research: FDA drug labels not proof of patent violation

Medical Xpress - medical research advances and health news [Uno… February 16, 2026
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Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. But a spate of recent court decisions has problematically treated that safety information in a drug's legally required package insert as key evidence in high-stakes patent cases against generic-drug manufacturers.

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