Written by Susan Neadle
Therapeutic and diagnostic goods that mix medications , equipment, and/or biological components are known as combination products . ” 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,” said the US Food and Drug Administration (FDA). Prefilled syringes, autoinjectors, pen injectors , inhalers, transdermal delivery systems, drug-eluting stents, and kits that combine pharmaceuticals and/or biological materials with drug administration devices are a few examples. The most recent information on combination product development, from the technologies involved to a successful launch, may be found in this handbook. Important and current pre- and post-market evaluations of worldwide combination product legislation, guidelines, best practices, and considerations are presented by the writers .
This guidebook :
Streamlines comprehension of global combination product guidelines and regulations
Examines the most recent cutting-edge factors and recommended procedures throughout the whole combination product lifecycle, from pre-market to post-market.
Examines the challenges with medical product assignment and classification that international regulatory bodies and business encounter.
With over 35 years of business experience, the editor is a known worldwide authority in Combination Products and Medical Devices, and he has an exceptional team of contributors. The Association for the Advancement of Medical Instrumentation (AAMI) has endorsed this.
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