Recent updates and challenges on the regulation of precision medicine: The United States in perspective.

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Abstract

The rapid progress in "omics", such as genomics, metabolomics, microbiomics, has paved the path for precision medicine and revolutionized the development of drugs and devices promising to meet unmet medical needs. The aim of the present study was to investigate the current regulatory framework established by the United States Food and Drug Administration (USFDA) and to identify challenges and concerns through study of related literatures in the PubMed database. We found that efforts were made to facilitate the implementation of precision medicine through organizational reform, publication of guidance documents, and continuous post-market surveillance. The challenges identified included the critical, fundamental structural requirements of databases, essential regulatory considerations for market approval, and the appropriate clinical use such as whole genomic sequencing tests especially for a newborn or even fetus. These issues are worth further research to devise an integral approach involving scientific, ethical, legal, and social considerations.