This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug 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 written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions.


The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products.

 

The recommendations in this guidance are also intended to help provide consistency to the content and format of IFU documents.


The recommendations in this guidance do not apply to labeling for stand alone devices or for device constituent parts of cross-labeled combination products if the device constituent is marketed under a device authorization (i.e., devices that are not constituent parts of drug- device, biologic-device, or biologic-drug-device combination products submitted under BLA or NDA), labeling for combination products for which the device constituent part provides the primary mode of action, or labeling intended for use by health care providers.


The recommendations in this guidance also do not apply to stand-alone devices regulated under a BLA, such as devices associated with blood collection and processing procedures.


In particular, this guidance relates to the PDUFA VI performance goal regarding guidance on patient-oriented labeling (e.g., IFU documents).


Resource Person: Barbara Pirola