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GUIDANCE DOCUMENT

Drug Interaction Information in Human Prescription Drug and Biological Product Labeling October 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-3903
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of drug interaction (DI) information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. The purpose of this guidance is to provide recommendations to help ensure that appropriate DI information is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners (HCPs) and includes content that guides the safe and effective use of the drug.

Submit Comments

Submit Comments Online

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-2024-D-3903.

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