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FDA (CDER)
GUIDANCE DRAFT
Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry
Published: 9/18/2025Detected: 3/20/2026

Summary preview

Establishes draft safety labeling implementation expectations to carry out FD&C Act section 505(o)(4), which may affect how sponsors incorporate and update safety-related labeling information for approved products.

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