Evaluating the Pressor Effects of Drugs; Public Workshop

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled ``Evaluating the Pressor Effects of Drugs.'' This public workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of this public workshop is to bring the stakeholder community together to discuss 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. Agency staff will present findings related to the use of ambulatory blood pressure monitoring to assess treatment effects.