FDA Finalizes Instructions for Use Guidance

The following is an abbreviated version of the original announcement.

The FDA has announced the availability of a guidance for industry entitled “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products—Content and Format.” The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products and to help provide consistency to the content and format of IFU documents.

For drugs for which self-administration may be complicated, the IFU is intended to give directions that are clear and understandable for patients, and therefore, promote the safe and effective use of that drug. For example, IFUs may be appropriate for a drug product with one set of dosing instructions for adult patients and another set for pediatric patients. The IFU is developed by the applicant, reviewed and approved by FDA, and provided to patients when the drug product is dispensed.

This guidance finalizes the draft guidance entitled “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format,” issued on July 2, 2019. The FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include a change in title. in addition to editorial changes to improve clarity.

This guidance has been issued consistent with the FDA’s good guidance practices regulation and represents the current thinking of FDA on “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products—Content and Format.” It does not establish any rights for any person and is not binding on the FDA or the public. An alternative approach can be used if it satisfies the requirements of the applicable statutes and regulations. To download a copy of the guidance, click here.