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Imprese · 31/05/20181 min di lettura
Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability
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Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessment of Pressor Effects of Drugs."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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →