This post was written by Erin Janssen and Areta Kupchyk. 

On October 12, 2011 the FDA announced the availability of guidance for the industry entitled “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 for human prescription drug and biological products. The recommendations in the guidance are designed to ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format. The guidance provides recommendations on how to determine which adverse reactions are significant enough to warrant inclusion in the “Warnings And Precautions” section; how to decide what situations warrant a “Contraindication,” and when to include a “Boxed Warning.” The guidance also provides recommendations on how to organize each section and what information to include when describing warnings and precautions, in situations when the use of the product is contraindicated, and in a boxed warning.