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Business · 31/01/2022Updated: 10/17/2026 · 1 min read

FDA Publishes Final Guidance on Premarket Pathways for Combination Products

Summary

The Food and Drug Administration (FDA) has released a final guidance document outlining principles for premarket review of combination products, aiming to facilitate the development of safe and effective combination products in line with the 21st Century Cures Act.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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