Combination Products: A Comprehensive Guide to Development, Regulations, and Best Practices

Combination products, as defined by the US Food and Drug Administration (FDA), are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. These products include a wide range of items such as 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, edited by a recognized international Combination Products and Medical Device expert with over 35 years of industry experience, 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.

Endorsed by AAMI (Association for the Advancement of Medical Instrumentation), this comprehensive guide reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market. It also reviews medical product classification and assignment issues faced by global regulatory authorities and industry.

Product Details:

Publisher: CRC Press; 1st edition (May 16, 2023)
Language: English
Hardcover: 592 pages
ISBN-10: 1032291621
ISBN-13: 978-1032291628