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

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 understanding for 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.

Author: Susan Neadle