Comments on the FDA’s Draft Guidance on the Assessment of Pressor Effects of Drugs

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Public Citizen, joined by two academic physicians, urged the Food and Drug Administration (FDA) to revised its draft guidance on the assessment of pressor effects of drugs to specify, among other things, the following: (a) a time interval that distinguishes short-term drug use from long-term use; (b) what constitutes a large blood pressure increase for drugs intended for short-term use; and (c) for drugs intended for long-term use, a requirement for premarket cardiovascular safety data for drugs that raise SBP more than 2 mm Hg or that raise DBP more than 1 mm Hg compared with a placebo.