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# Suggestions for Use Instructions Guidance
- URL: https://www.fdaweb.com/suggestions-for-use-instructions-guidance/
- Published: 2019-09-11T12:00:00.000Z
- Updated: 2026-09-15T01:49:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144977

Bayer says an FDA draft guidance on the content and format of instructions for use (IFU) for drug, biologic, and combination products “provides an opportunity to align with the previous effort by FDA to consolidate the current formats of patient labeling into patient medication information (PMI). The finalization of this initiative may be an opportunity to clarify which topics should solely be included in PMI, those topics that may be repeated in an IFU, and those topics that are appropriate to appear in both. This is also an opportunity to clarify those cases where an IFU is a subsection of PMI.” The company comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-1615-0008&ref=fdaweb.com) has general comments on FDA-approved patient labeling, implementation schedule, product title nonproprietary name, and drug device combination software. It also provides line-by-line specific comments.

The Pharmaceutical Printed Literature Association [says](https://www.regulations.gov/document?D=FDA-2019-D-1615-0009&ref=fdaweb.com) that as the agency considers guidance for IFU, cognitive principles must be implemented to increase the amount and depth of the intended message sought to be conveyed to patients. “The IFU draft guidance properly identifies the importance of visuals, spacing, and color,” it says, “yet does not standardize the application of these layout and design elements.”

Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/document?D=FDA-2019-D-1615-0009&ref=fdaweb.com) it appreciates issuance of the guidance, which is a PDUFA 6 commitment, to help ensure IFC consistency and provide additional clarity for sponsors. The trade group recommends that FDA solicit input on the guidance from CDRH since it covers drug-device and biologic-device combinations. PhRMA comments on dosing information, documents related to the IFU, and visual of the drug product, and has line-by-line specific comments.

Finally, AbbVie [says](https://www.regulations.gov/document?D=FDA-2019-D-1615-0011&ref=fdaweb.com) it supports the PhRMA comments and specifically addresses factors to consider for IFU acceptability, considerations to address various IFC formats, and IFUs intended for multiple user groups. It also includes line-by-line comments.