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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and 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 help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of such prescription products. Thus, the recommendations in this guidance are ultimately intended to enhance patients’ understanding of IFUs and facilitate the development and approval of IFUs that are clear and helpful to patients.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 2019-14060 .