Drugmakers given new guidance on "Instructions for Use" documents

2 July 2019

The US Food and Drug Administration has issued new draft guidance providing recommendations for drugmakers on how to create an Instructions for Use (IFU) document.

The guidance document is designed to help drugmakers in developing the content and format of IFUs, for both regular drugs and biologics, as well as drug-device or biologic-device combinations.

The IFU is developed by applicants for patients who use drug products that have complex or more detailed patient-use instructions.

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