{"product_id":"9781032291635","title":"The Combination Products Handbook : A Practical Guide for Combination Products and Other Combined Use Systems by Susan Neadle","description":"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.   This handbook:Brings clarity of understanding for global combination products guidance and regulationsReviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-marketReviews medical product classification and assignment issues faced by global regulatory authorities and industryThe 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.\u003cbr\u003eBinding: Paperback \/ softback","brand":"Gardners","offers":[{"title":"Default Title","offer_id":56295920304501,"sku":"9781032291635","price":57.99,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0612\/7193\/3106\/files\/9781032291635.jpg?v=1762769621","url":"https:\/\/backstory.london\/products\/9781032291635","provider":"Backstory","version":"1.0","type":"link"}