FDA Drug Interaction Information in Human Prescription Drug and Biological Product Labeling—Content and Format; Draft Guidance for Industry (Catapult’s regulatory round-up – October 2024)

This draft guidance provides recommendations to applicants of human prescription drug and biological products on appropriate placement and content of drug interaction (DI) information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. Comments can be submitted until 22nd January 2025. Text published on the 5th of November 2024 in Catapult’s Regulatory Round-up – October 2024 (catapult.org.uk).