The guidance, released in July 2022, relates to the content and format of Instructions for Use (IFU) submitted to the FDA under a new drug application (NDA) or a biologics license application (BLA).

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry
Date: July 2022
https://www.fda.gov/media/128446/download

IFUs are written for patients and caregivers and explain how to use the drug or product. Commonly they include instructions for preparation, use, handling, storage, and disposal and are written in detailed, step-by-step instructions.

The FDA guidance aims to ensure that IFUs are clear, concise and easy to understand, helping to safeguard the safe and effective use of drug products. The FDA also wants to ensure that IFUs are consistent across different FDA-approved drug products.

The document is a revised version of a draft released for comment in 2019. Changes to this draft include a longer discussion of the role of human factors in the development of IFU, stating that more human factor data should be used to support the content and design of IFUs.

This version also adds more detail on the language to be used for labelling drugs for self-administration. It states that when self-administration of the drug might be complicated, the IFU should give clear directions to promote the safe and effective use of the drug.

It also states that drug labels should include a phone number to allow patients and caregivers to report problems and adverse reactions and advises applicants to meet with the Agency during the development phase to discuss creation of the IFU.

Other recommendations in the document include how to achieve consistency with FDA-approved prescribing information and specific content and formatting recommendations, including important information for patients, how to create visuals of drug products, and which typefaces to use.

Related articles
FDA releases new guidance on bioavailability studies

FDA issues draft guidance on immunogenicity labelling

FDA issues new guidance on biosimilar development and the BPCI Act

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

 COMMENTS (0)