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What is Overview of Combination Products about?

This document discusses combination products, which are defined as products containing two or more regulated components such as drugs, devices, and biologics. It describes 8 types of combination products and provides examples. The roles of the Office of Combination Products include classifying products, assigning them to FDA centers, and overseeing reviews involving multiple centers. Combination products approved for marketing include drug-coated stents, prefilled drug delivery systems, surgical kits contai

Author

Pradipta Mondal

Language

EN