The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (EPUB)

The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (EPUB)

Combination Products Handbook by Susan Neadle Dive into the innovative realm of combination products—therapeutic and diagnostic solutions integrating drugs, devices, and/or biological products. Per the US Food and Drug Administration (FDA), a combination product encompasses any blend of a drug and a device, a biological product and a device, a drug and a biological product, or all three together. Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits combining drug administration devices with drugs and/or biological products. This authoritative handbook offers the most current insights on developing combination products, covering cutting-edge technology to effective market delivery. The authors deliver vital pre- and post-market evaluations of international combination product regulations, guidance, considerations, and best practices.

This indispensable resource: • Illuminates global combination product regulations and guidance for clear comprehension • Explores state-of-the-art best practices and considerations across the full combination product lifecycle, from pre-market to post-market • Analyzes medical product classification and assignment challenges confronted by global regulatory authorities and industry experts

Edited by Susan Neadle, a globally esteemed Combination Products and Medical Device authority with over 35 years of industry expertise, alongside a distinguished team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation. Secure your copy now and lead the way in mastering combination product development!