FDA Publishes Guidance on the Effects of Drugs on Blood Pressure

May 30, 2018

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

On May 30, 2018, FDA published draft guidance that provides sponsors with advice on the premarketing assessment of a drug’s effect on blood pressure. The agency states that, because elevated blood pressure in patients can increase risk of stroke, heart attack, and death, the effect of a drug on blood pressure should be considered in a benefit-risk assessment.

The guidance addresses precision of blood pressure measurements, and FDA recommends systemic characterization of a drug’s effect on blood pressure during drug development. The guidance also addresses impact in short-term use of a drug compared to long-term use.

Source: FDA