Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability

Resumen

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Assessment of Pressor Effects of Drugs." This draft guidance is intended to advise sponsors on the premarketing assessment of a drug's effect on blood pressure.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 This draft guidance revises the draft guidance for industry "Assessment of Pressor Effects of Drugs" issued on May 31, 2018.