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Knowledge of pharmaceutical company operations enables attorneys to identify where evidence of manufacturer knowledge exists: FDA approval processes for new drug applications and what safety data manufacturers must provide Post-market surveillance requirements including adverse event reporting systems and periodic safety reviews Pharmaceutical company organizational structures and which departments handle safety signals and label changes Industry standards for warning label development and what constitutes adequate warnings under FDA regulations Knowledge of clinical trial data, safety databases, and internal communications about drug risks When Ozempic received FDA approval in December 2017, Novo Nordisk submitted clinical trial data showing the drugs efficacy for type 2 diabetes patients

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doi:10.1016/j.jdiacomp.2020.107733 A Review of Diabetic Gastroparesis for the Community Pharmacist