title: Drug-device combination products: regulatory landscape and market growth.
abstract: Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years.
authors.affiliation: Thomson Reuters, Barcelona, Spain. scientific.prousjournals@thomsonreuters.com.
authors.forename: L
authors.initials: L
authors.lastname: Bayarri
mesh_terms: D018795:Device Approval; D017277:Drug Approval; D054855:Drug-Eluting Stents / Q000592:standards*; D006801:Humans; D040541:Marketing; D014481:United States; D014486:United States Food and Drug Administration
keywords: Combination product; Drug-device combination; Medical device; Regulatory