The Combination Products Handbook - A Practical Guide for Combination Products and Other Combined Use Systems (Hardcover)

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 combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important 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 with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.