Instructions for Use -- Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products -- Content and Format; Draft Guidance for Industry; Availability

Please see the attached comments of the National Association of Chain Drug Stores on the draft guidance outlining the content and format of an Instructions for Use (IFU) document for patients who use drug products that have complicated or detailed patient-use instructions. We thank the Food and Drug Administration for considering our input on this matter.