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Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format October 2011

Final

Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to assist applicants and reviewers in drafting the WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, and BOXED WARNING sections of labeling, as described in the final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (21 CFR 201.56 and 201.57). The recommendations in this guidance are intended to help ensure that the labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.
 


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.