FDA releases new guidance on instructions for use for biologicals

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The US Food and Drug Administration (FDA) has released new guidance on Instructions for Use (IFU) for human prescription drugs and biological products. The guidance is an updated version of a 2019 draft and explains how to create safe and consistent IFUs.

Label FDA V14b20

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

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.

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View last week’s headline article: Perspectiva de la regulación de biosimilares en América Latina para mejorar el acceso al tratamiento del cáncer

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de de la semana pasada: Perspectiva de la regulación de biosimilares en América Latina para mejorar el acceso al tratamiento del cáncer

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


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Source: US FDA

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