ABSTRACT
There are two unique pathways for the regulatory qualification and approval of biomarkers at the FDA: the Biomarker Qualification Pathway (BQP) at the Center for Drug Evaluation and Research (CDER) and the Companion Diagnostic Approval (CDA) at the Center for Devices and Radiological Health (CDRH). Both of these regulatory pathways have witnessed a decade of development and use. Both of these regulatory pathways started with the Pharmacogenomics Guidance [1] and Critical Path for Innovation [2] documents in 2004 and 2005. These documents opened in the FDA both the science and regulatory review of genomic data, as well as the concept of biomarkers as critical components for the development of precision medicine. Although the genesis for both of these pathways has a lot in common, the outcomes for their application and their impact on the development of Precision Medicine have been dramatically different.
