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Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), 'a combinationproduct is one composed of any combination of a drug and a device; a biological product anda device; a drug and a biological product; or a drug, device and a biological product.' Examplesinclude prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-elutingstents, and kits containing drug administration devices co-packaged with drugs and/or biologicalproducts. This handbook provides the most up-to-date information on the development of combinationproducts, from the technology involved to successful delivery to market. The authors presentimportant and up-to-the-minute pre- and post-market reviews of combination product regulations,guidance, considerations and best practices.This handbook:• Brings clarity of understanding for combination products guidance and regulations• Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market• Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert withover 35 years of industry experience and has an outstanding team of contributors. Endorsed byAAMI - Association for the Advancement of Medical Instrumentation.
