Combination Products Handbook

<p>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 delivery systems 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 international combination product regulations guidance considerations and best practices.</p><p>This handbook:</p><ul> <li>Brings clarity of understanding for global combination products guidance and regulations</li> <li>Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle pre-market through post-market</li> <li>Reviews medical product classification and assignment issues faced by global regulatory authorities and industry</li> </ul><p>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.</p>