FDA Issues Guidance for Industry On Drafting Warnings in Drug Labels

The Food and Drug Administration released a guidance to assist applicants and reviewers in drafting the warning sections of labeling for prescription drug and biological products, according to a notice published Oct. 12 in the Federal Register (76 Fed. Reg. 63303).

FDA said the guidance, Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format, 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 ...