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However, our Spotlight: Americans for Medical Progress/Vital Role of Animals in Research Dear FDA Matters readers: This column is the second in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community

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Table 2 Human studies evaluating the anti-inflammatory effect of GLP-1 in atherosclerosis

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However, the FDA has clarified that this difference must be relevant to the patients clinical needs, not merely a minor formulation change designed to evade regulation.17 The Enforcement Gap and Patent Rights While producing a copy violates FDA regulations, it does not automatically trigger patent litigation damages under the Patent Act