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비즈니스 · 2018. 5. 31.1 분 읽기
Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessment of Pressor Effects of Drugs." This guidance is intended to advise sponsors on the premarketing assessment of a drug's effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure may therefore be an important consideration in benefit-risk assessment.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →