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

Issue Date: October 12, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Final

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

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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