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GUIDANCE DOCUMENT

Assessment of Pressor Effects of Drugs Guidance for Industry Draft Guidance for Industry February 2022

Download the Draft Guidance Document
Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-1636
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This draft guidance is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure.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 is, therefore, an important consideration in risk assessment and product labeling. This draft guidance revises the draft guidance for industry “Assessment of Pressor Effects of Drugs” issued on May 31, 2018.

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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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