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AC advisory committee AE adverse event AESI adverse event of special interest AHA antihyperglycemic agent AR adverse reaction BLA biologics license application BPCA Best Pharmaceuticals for Children Act BRF Benefit Risk Framework CBER Center for Biologics Evaluation and Research CDER Center for Drug Evaluation and Research CDRH Center for Devices and Radiological Health CDTL Cross-Discipline Team Leader CFR Code of Federal Regulations CIs clinical investigator CI confidence interval CMC chemistry, manufacturing, and controls COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms CRF case report form CRO contract research organization CRT clinical review template CSR clinical study report CVD cardiovascular death DBP diastolic blood pressure DMC data monitoring committee DKA diabetic ketoacidosis ECG electrocardiogram eCTD electronic common technical document eGFR estimated glomerular filtration速率ER扩展释放的ETASU元素可确保安全使用FAS完整分析集FDA食品药物管理局FDAAA食品和药物管理局修正案2007年FDASIA FDASIA食品和药物管理局安全和创新法FDCP固定剂量组合产品FPG禁食产品FPG禁食等质量等离子体葡萄糖
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