이 기사의 번역을 준비하고 있습니다. 그동안 영어 원문을 임시로 표시합니다.
비즈니스 · 2022. 2. 4.1 분 읽기
Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Assessment of Pressor Effects of Drugs." This draft guidance is intended to advise sponsors on the premarketing assessment of a drug's effect on blood pressure.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 is, therefore, an important consideration in risk assessment and product labeling. This draft guidance revises the draft guidance for industry "Assessment of Pressor Effects of Drugs" issued on May 31, 2018.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →