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GUIDANCE DOCUMENT

Assessment of Pressor Effects of Drugs Guidance for Industry May 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-1636
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.

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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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1636.

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