FDA Issues Final Guidance on Instructions for Use Documents

July 14, 2022

The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.”

The Instructions for Use (IFU) document is written for patients or their caregivers who use prescription drug and biological products that have complicated or detailed instructions. The recommendations in this guidance are intended to help provide consistency to the content and format of IFU documents and to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products.

This guidance finalizes the draft guidance that FDA issued in July 2019 titled “Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format, Guidance for Industry.” In the final guidance, FDA added clarifying language, consolidated discussions of human factors, and aligned the final guidance with the standards used in other Center for Drug Evaluation and Research policy documents.

This final guidance is a commitment included in the Prescription Drug User Fee Act (PDUFA) VI performance goals letter related to guidance on patient-oriented labeling (e.g., IFU documents).

Download the Final Guidance Document

Read the Federal Register Notice

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.




FDA North America

July 14, 2022

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...

Read More
ANDA CDER

July 14, 2022

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...

Read More
ANDA FDA

July 14, 2022

How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”

On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...

Read More