US FDA Plans To Standardize Review Of Blood Pressure Effects Of New Drugs

Approach is modeled after the interdisciplinary review team established more than a decade ago to review data on QT interval effects, FDA says; at a recent Duke meeting on assessing off-target pressor effects, discussion focused on lessons learned in the QT space that could be applied to studying blood pressure effects.

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The US FDA intends to adopt a more systematic approach to advice and data reviews on the blood pressure effects of new drugs that is modeled after its evaluation of pro-arrhythmic effects.

Norman Stockbridge, director of FDA’s Division of Cardiovascular and Renal Products, said the agency is looking to standardize its approach to evaluating pressor effect data much as it has done...

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