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# Safety Labeling Changes Guidance
- URL: https://www.fdaweb.com/safety-labeling-changes-guidance/
- Published: 2025-09-18T12:00:00.000Z
- Updated: 2026-09-14T15:22:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159894

FDA has published a draft guidance, *Safety Labeling Changes—Implementation of Section 505 (o)(4) of the Federal Food, Drug, and Cosmetic Act*, to provide information on the agency’s implementation of a provision authorizing it to require application holders for certain drugs to make labeling changes based on new safety information, including information related to reduced effectiveness, that becomes available after approval of the drug, that FDA determines should be included in its labeling. The [document](https://www.fda.gov/media/188793/download?ref=fdaweb.com) revises a 7/2013 guidance and will replace it once the draft is approved.

Significant changes from the 2013 guidance, FDA says, include the inclusion of information related to Congress’ 2018 changes to the statutory definition of “adverse drug experience,” and a description of how the agency reviews and acts on safety labeling changes when new safety information applies to multiple application holders and the safety labeling change is issued to multiple applicants. The guidance also is said to clarify when FDA may disclose safety labeling changes and order letters, and to reflect current safety labeling change processes and procedures that have been updated since 2013.