The requirements of FDA (United States) to bioanalytical method validation published in the new 2018 guidance are reviewed. The validation is needed to confirm the reliability of bioanalytical methods used for the determination of analyte concentration. The history of regulation of bioanalytical method validation is briefly described. An overview of the key changes and additions to the FDA guidance on bioanalytical validation is given, which includes the unified requirements to chromatographic analyses and ligand binding assays, reference to biomarkers validation, new technology section (e.g. Dry Blood Spots), and fit-for-purpose concept. A comparison of the FDA and Eurasian Economic Union (EAEU) requirements to the validation parameters of chromatographic assays is made. Despite some differences both the number of parameters and the acceptance criteria, the FDA and EAEU requirements are generally consistent.