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USFDA Guidance on Premarket Review of Combination Products

US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways for Combination Products on 31-January,2022.

This guidance presents the current thinking of FDA on principles for premarket review of combination products. This guidance offers general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed.

The remainder of this guide focuses on how to determine which type of premarket submissions may be appropriate for combination products. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews.

FDA is publishing this guidance as part of its efforts to implement Cures Act section 3038 and in keeping with the Agency’s long-standing commitment to transparency, efficiency, and regulatory consistency, to facilitate development of safe and effective combination products.


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