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비즈니스 · 2023. 5. 26.1 분 읽기
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products; Draft Guidance for Industry; Availability
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요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products." This draft guidance is intended to help sponsors develop antidiabetic drugs for adults and children with type 1 and type 2 diabetes mellitus. In this draft guidance, antidiabetic drug refers to drugs intended to improve glycemic control, including drugs intended to reduce diabetes-related hyperglycemia (i.e., antihyperglycemic drugs) and drugs intended to mitigate iatrogenic hypoglycemia associated with diabetes management.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →