Assessment of Pressor Effects of Drugs

On 3 February 2022 the FDA published the draft guidance for industry.

This draft guidance is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure.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.

The recommendations in the guidance are generally applicable to new drugs with systemic bioavailability and to approved drugs for a new indication/population with a higher cardiovascular risk or when a new dosing regimen results in significantly higher or more prolonged exposure.

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