by Susan Neadle
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.
