ABSTRACT
This chapter describes the safety and effective biomakers that the US Food and Drug Administration have included in drug or biologics labels for cancer treatment. It includes relevant regulations regarding diagnostics for biomarker testing. The chapter provides the regulatory process for the evaluation of biomarkers and rational for inclusion of biomarkers related information in the drug and device label. The mission of the United States Food and Drug Administration is to protect and promote public health through application of innovative science in drug development and drug usage. In cancer treatment, the objective is to destroy the malignant cells without harming the normal tissue or organs required for normal function. Biomarkers have been effectively used in detecting the stages of cancer, or prognosis of a particular cancer or in evaluating effect of a therapy. Biomarker has the potential to identify sources of inter-individual variability in drug response that affect both efficacy and safety.
