Pharmacogenomics is the study of how genes affect a person’s response to drugs. Genomics is playing a major role in identifying information from the human body and applying it to current drug therapy. It raises significant regulatory complexities for the diagnostics arm of regulatory agencies. As it contains genetic testing (E.g. DNA, RNA), complexity of genetic arrangements makes it difficult to find correct gene that affect the drug response. As currently FDA is recommending the use of pharmacogenomics in drug development the USFDA regulations assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug’s pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The purpose of the regulations is to provide advice on general principles of study design, data collection, data analysis in early-phase trials, labelling and data submission.