Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems


SKU: 9781032291628
Editor: Neadle, Susan
Publication Date: 05/16/2023
Publisher: CRC Press
Binding: Hardcover
Media: Book
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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 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 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.