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The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
On May 30, 2018, FDA published draft guidance that provides sponsors with advice on the premarketing assessment of a drug’s effect on blood pressure.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.