Drug, Device, or Both? Overview of FDA Premarket Regulation of Combination Products

A vaccine in a prefilled syringe. A metered-dose inhaler. A nicotine patch. A drug-eluting stent. These are examples of so-called “combination products” that mix drug, device, and/or biologic. They are among the most closely scrutinized products by FDA, European, and other authorities. While these combination products are subject to overlapping regulatory oversight, their compliance pathway is not always clear-cut. In this article, we will explain the basics of how they are regulated. Examples of Combination Products Before we take a […]

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