ABSTRACT

Why a chapter on medical devices in a book on pharmaceutical information? The device and pharmaceutical industries, along with their attendant information needs, have for the most part operated independently of each other. However, the trend toward so-called combination products-comprising two or more drug, medical device, or biologic components-is bringing the device and pharmaceutical industries much closer together, often via formal licenses or partnerships. The Food and Drug Administration (FDA), with separate centers for regulating drugs and devices, created the office of combination products

(OCP) in 2003 to more effectively deal with the intersecting regulatory aspects of such products.