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The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
On July 1, 2019, FDA published guidance on the content development and format of Instructions-for-Use documents (IFUs) to be submitted with a new drug application (NDA) or a biologics license application (BLA). The guidance was written to help applicants develop consistent content and formats across IFUs that will make patient information regarding complicated or detailed use instructions easy to understand.
The guidance applies to human prescription drugs, biological products, and drug-device or biologic-device combination products. It does not apply to labeling for standalone medical devices legally marketed under medical device application types or to labeling intended for use by healthcare providers. It also does not apply to devices regulated under a BLA, such as devices associated with blood collection and processing procedures.