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FDA regulating power & guidelines
Book chapter

FDA regulating power & guidelines

Temilolaoluwa O. Daramola and Aderinsola A. Aderonmu
Handbook for Designing and Conducting Clinical and Translational Surgery, pp 87-91
01 Jan 2023

Abstract

Accelerated approval process Breakthrough therapy Investigational device exemption Sentinel initiative
A clear understanding of the other products regulated by FDA provides surgical researchers with better insight about legalities associated with the commercialization of products that can impact the population catchment that they serve. This chapter will provide an overview of those products and the FDA's scope of regulation.

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