US FDA Blood Pressure Risk Assessment Guidance Uses Unique Format
As agency embraces bullet-point format, old-school draft full of call-outs and solicitations seems unlike anything before or since. Regardless of style, FDA's testing recommendations for developmental therapies are of broad, substantive interest to industry.
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Revised draft guidance proposes that sponsors of new drugs intended for chronic use should rule out a 3-mmHg blood pressure increase in pre-market trials.
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.
The CDER director said the US agency is always thinking about the next iteration of the prescription drug user fee program, but added that it has not yet discussed specifics.