FDA Issues Draft Guidance on Labeling for NDAs, BLAs and Combo Products

July 10, 2019

The FDA released draft guidance on Monday on the content and formatting of Instructions for Use (IFU) for prescription drugs, biologics, and drug- or biologic-device combinations.

IFUs should be “written in nontechnical language and clearly state the actions a patient should take to use the product,” the agency says. The guidance recommends using active voice and commands, with sentences that start with an action verb. It also provides sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal.

The agency notes that the main purpose of an IFU is to provide “detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner.” The FDA recommends including any relevant information from the prescribing information that describes how to use the product, as well as any additional details necessary for safe and effective use.

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