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

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. The US Food and Drug Administration (FDA) defines a combination product as 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.

Global Combination Products Guidance and Regulations

This handbook brings clarity of understanding for global combination products guidance and regulations. It reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market. The handbook also reviews medical product classification and assignment issues faced by global regulatory authorities and industry.

About the Editor

The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. The editor has an outstanding team of contributors who are experts in their respective fields.

Endorsement

This handbook is endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

Product Details

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