A patient instruction for use (IFU) document for human prescription drug and biological products by FDA

In July 2022, the FDA published guideline providing recommendations for developing the content and format of documentation for labels and instructions for use (IFU) for prescription drugs for human and biological products.

About the content:

1. Consistence

Content is consistent with FDA-approved prescribing information.

2. Language

– Using language appropriate to the intended audience.

– Using sentences with a structure that starts with a verb will make the content short and easy to follow.

E.g.: “Wash your hands” (instead of “You should wash your hands”) and “Shake the vial until the solution is dissolved and clear” (instead of “You should shake the vial until the solution is dissolved and clear”).

– FDA recommends limiting the use of technical words.

E.g.: “patch” should be used instead of the term “percutaneous treatment”.

– Acronyms are not recommended.

– Dose indications must be clearly written.

E.g.: “1 mg” instead of “1.0 mg”.

3. Heading

Standardized headings improve readability for patients. Main headings and sub-headings must clearly identify the main content; helps organize and differentiate topics; helps patients to find information quickly and easily.

In addition, this guideline also covers the basic content that should be presented in the IFU.

About the format

– FDA recommends using sans-serif fonts for IFU content. Recommended sans-serif fonts include, but are not limited to, Verdana and Arial.

– It is not recommended to use any inversions (e.g. white or neutral styles on a darker background), lightface, shading, highlighting, condensed type, or narrow fonts.

– The font size should not be less than 10 for any part of the IFU, except not less than 8 for the following:

• Name and place of business of the manufacturer, packer, and/or distributor (for products marketed under New Drug Application or Abbreviated New Drug Application)
• Name, address, and license number of the manufacturer (and, if applicable, distributor) (For products marketed under the Biologics License Application)
• Claim statement (Example: This leaflet is approved by the U.S. Food and Drug Administration)
• Month and year of initial approval or date of IFU modification.

REFERENCES:

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format