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FDA Releases Guidance for Industry on Developing Appropriate Warning Labeling
Amended labeling requirements aimed to help ensure clear, useful, informative, and consistent warning labeling are described in a new FDA guidance document. The document, “Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format,” was developed to assist applicants in drafting the warnings and precautions, contraindications, and boxed warning sections of labeling. The guidance advises applicants on topics including adverse reactions that should be included, risks or hazards that should be included, and when contraindications and boxed warnings should be included, as well as guidance on content and format.
