FDA Draft Guidance: Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format

FDA Draft Guidance: Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format

Today, the U.S. Food and Drug Administration issued a draft guidance, “Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products  — Content and Format” that provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. The recommendations in this guidance are intended to promote development of consistent content and format across IFUs to ensure that patients receive clear, concise information that is easily understood for the safe and effective use of such prescription products.

This guidance is one in a series of guidances the agency has developed to assist applicants with the content and format of labeling for human prescription drug and biological products to make information easier for health care providers and patients to access, read, and use. This guidance also fulfills the performance goals under the Prescription Drug User Fee Act (PDUFA) VI related to guidance on FDA-approved patient-oriented information (e.g., instructions-for-use). For more information about the guidance and how to submit comments to the docket (2019-14060), please see visit: Instructions for Use (IFU).