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Combination products
Book chapter

Combination products

Andrew L. DiMatteo, Jessica Barson and Ramesh Raghupathi
Handbook for Designing and Conducting Clinical and Translational Surgery, pp 539-545
01 Jan 2023
DOI: https://doi.org/10.1016/B978-0-323-90300-4.00072-0

Abstract

Abbreviated new drug application (ADNA) Biologics License Application (BLA) 510(k) Combination product Copackaged combination product Cross-labeled combination product New drug application (NDA) Office of Combination Products (OCP) Primary mode of action Single entity combination product
This chapter provides an understanding of what combination products are, presents common examples, explains the basics of the FDA approval process for combination products, discusses common challenges in the approval process, reveals some financial considerations, and mentions some funding resources for the development of combination products. As the marketplace for combination products continues to quickly rise, it is essential for current and future entrepreneurs, researchers, and scientists to understand these concepts. In doing so, they may avoid common pitfalls in combination with product development and regulatory approval. After reading this chapter, one should have a basic comprehension of what are combination products and how they are brought to market in the United States.

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