Abstract
This chapter discusses the regulatory framework and ongoing policy challenges for genomic medicine. Regulation of the medical uses of genomic technologies is an evolving and controversial field. In the ideal case, medical product regulation strikes an appropriate balance between protecting patients and fostering innovation. Such balance is difficult to achieve during the dynamic evolution of a new area of technology. Currently, the fields of genomic testing and pharmacogenomics are experiencing active growth. Regulatory and policy interest has led to a debate about the appropriate level of regulation of these technologies. The landscape of genetic test regulation is confusing and the vast majority of available genetic tests are developed in laboratories. Development of specific assays for use in clinical medicine requires a basic understanding of regulatory regimes. Exploratory assay development using human samples, for example, tissues or body fluids, are usually conducted under general human subject protection and privacy provisions implemented by academic institutions. Prior to undertaking analytical validation or clinical studies, it would be prudent for a developer to determine the potential regulatory status of the test and regulatory clearances needed to bring the test to market successfully.
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