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

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 patches, 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 combination product regulations,
guidance, considerations and best practices.

This handbook:

-  Brings clarity of unders