FDA Publishes Guidance on Instructions for Use in Patient Labeling

Article

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.

Source: FDA

 

Recent Videos
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Kate Coleman, vice president regulatory affairs, quality and compliance, Arriello, chats about industry trends and technological advances.
Industry Outlook 2025: The Rising Prominence of AI in Pharma
Adam Sherlock, CEO of Qinecsa, discusses the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.
Related Content
© 2025 MJH Life Sciences

All rights reserved.