5/6 June 2024
Following the previously published Readability Guideline, the US FDA published now a guidance document on Instructions for Use (IFU) labeling. The guidance provides recommendations for developing the content and format of an IFU document for human prescription drugs and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).
The IFU is a form of prescription drug labeling and is written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions (such as requiring the patient to perform multiple steps to prepare, administer, store, and/or dispose the drug). The recommendations are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use. For a combination product that includes a device, the IFU provides directions on the use of the device (e.g., regarding device handling, injection of the drug or biologic, and product storage of the device or combination product as a whole). The IFU is developed by the applicant, reviewed and approved by FDA, and provided to patients when the product is dispensed.
The FDA recommends using a sans-serif font for all text in the IFU because sans serif is easier to read than a serif type font. Recommended sans-serif fonts include, but are not limited to, Verdana and Arial. In addition, the agency recommends not to use any reverse type (such as white or neutral color type on a darker color background), lightface, shading, highlighting, condensed type, or narrow fonts. These techniques can make reading more difficult for patients.
Overall, the agency recommends that the font size should be no smaller than 10 points for any section of the IFU, except no smaller than 8 points for the following:
More information is available in FDA´s Guidance document Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format.