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...

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