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GUIDANCE DOCUMENT

Assessment of Pressor Effects of Drugs Guidance for Industry May 2018

Draft

Not for implementation. Contains non-binding recommendations.

Assessment of Pressor Effects of Drugs Guidance for Industry

Docket Number:
2018-11642
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure can therefore be an important consideration in benefit-risk assessment.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2018-11642.