Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability

Özet

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessment of Pressor Effects of Drugs."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.