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BioWorld - Monday, July 27, 2026
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Home » Debate over Orange Book device listings heard on multiple fronts
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Debate over Orange Book device listings heard on multiple fronts

May 1, 2024
By Mari Serebrov
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
BioWorld Medical technology Regulatory Combination drug-device Endocrine/metabolic Respiratory Small molecule U.S. Courts FDA FTC Patents

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