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Abstract

In current scenario of innovative products, some of the products which hold a premier stand are those that combine, in some combination or others, elements of drugs, devices, and biologics. Drug-device combination products introduced a new change in medical product development, regulatory approval, and industrial interaction that provide valuable lessons for the development of new generations of medical products. These cutting-edge technologies have yielded the products to deliver drugs and biologics to specific targets within the body. In this paper, an introduction is given about combination products, their usefulness in the current drug delivery technologies, challenges in their regulation along with a brief history of these products, and overview of their regulatory status in major pharmaceutical jurisdictions. A brief review on regulatory path for their approval in various countries with special focus on drug device combinations along with the challenges faced by industries regarding their market approval is also given. For their market approval, the role and responsibilities of regulatory authority are addressed along with a brief description on review steps taken by Food and Drug Administration.

Keywords

Combination products drug-device combinations Office of Combination Products Primary Mode of Action European Union USA (United States of America)

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A comparative study of regulatory prospects for drug-device combination products in major pharmaceutical jurisdictions

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