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RECENT UPDATES

Mar 13, 2026
424 - Comparative and Superiority Claims - addition of FDA Untitled Letters alleging misleading implied superiority claims
Mar 12, 2026
427 - Other Claims for Prescription Drugs - updated with information on enforcement actions due to claims implying sameness with FDA-approved products
Feb 13, 2026
422 - Accelerated Approvals and Surrogate Markers - updated with information on handling Complete Response Letters
Feb 1, 2026
931 - Untitled Letters for Prescription Drugs - updated with recent numbers and policy changes
Dec 10, 2025
527 - Considerations for Prescription Biological Reference and Biosimilar Products - information from final guidance issued in December 2025

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