FDA’s Draft Guideline for Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic- Device Combination Products – Content and Format

FDA released Draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products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.

“FDA recommends that information appear as logically ordered, detailed, step-by-step instructions so that patients can safely and effectively take or administer the drug product. For drug products with more than one method of administration (for example, sprinkle capsule contents into food or drink; administer by feeding tube for patients who have difficulty swallowing), FDA recommends using distinct sections to separate the instructions for each administration method,” the draft says.

 

For more detail, please refer below detail:

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