FDA Leveraging

Paper Summary:

In this paper, FDA leveraging and the impact special interest groups could have on protection of human research subjects is discussed. Initially, an overview is provided of FDA leveraging, including a definition of leveraging and a discussion of relevant background information, basic principles, and types of partnerships involved in the process. Subsequently, the oversight of FDA leveraging is described. This is followed by a discussion of the legal and ethical issues associated with the process. Conflicts of interests (COI) as well as potential conflicts of interest are identified. After this, information is provided as to strategies to avoid the emergence of COIs. Finally, a summary of the information provided within the paper is provided.

From the Paper:

"Leveraging, as implemented and utilized by the US Food and Drug Administration (FDA), has been defined as the development of relationships and/or formal agreements with others outside the FDA, designed and intended to enhance FDA's capacity to meet its public health mission. As such, leveraging within FDA represents a continuum for gaining advantage and support in fulfilling its public health goals and undertaking."

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