Chapter 23 - Clinical Translation and Regulations of Theranostics

Abstract

This chapter is an overview of the regulatory aspects of cancer theranostics. The regulatory requirements for theranostics as a field have not been discussed. The ethics and regulatory oversight of pharmacogenomics and nanomedicine are likely to affect the future review of theranostics. The FDA has stated that nanotechnology applications will be reviewed according to existing regulations for devices, drugs, and biologics. However, academic groups voice concerns that the current regulatory structure does not have the means to provide adequate oversight of this rapidly emerging technology. Similarly, pharmacogenomics, another rapidly growing field, has issues related to standardization, safety, and efficacy research that may require additional regulatory oversight. In this chapter, the ethics of human subject protection and FDA review of investigational drugs and devices as they relate to theranostics are discussed. The scope of the chapter is limited to the initial translation from preclinical to early phase studies.