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The FDA needs data across different patient populations to feel confident that the drug is both safe and effective broadly, not just in one narrow group
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Authors: Duy Do, PhD⊕ Truveta, Inc , Bellevue, WA, Karthik Murugiah, MD ⊕ Center for Outcomes Research and Evaluation, Yale New Haven Hospital , New Haven, CT Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine , New Haven, CT, Mitsuaki Sawano, MD, PhD ⊕ Center for Outcomes Research and Evaluation, Yale New Haven Hospital , New Haven, CT Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine , New Haven, CT, Brianna M