← FDA GUIDANCE
FDA GUIDANCE · DRAFTSeptember 18, 2025
Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry
What this record is not
Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.
Status
Draft
Topic
Labeling
Issue date
September 18, 2025
This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.
READ THE FULL GUIDANCE
The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.
View on fda.gov →