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Within 20 days of FDA acceptance of its 351(k) application, the biosimilar applicant shall provide the RPS with a copy of its complete application and detailed manufacturing information including the cell line, expression system, purification process, formulation, and quality control specifications

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Based on recent studies, oral semaglutide for weight loss requires doses that are much higher for weight management than for diabetes management in lowering blood sugar

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Thirty-six percent (36%) reported reduced alcohol consumption