Regulatory Blog

The U.S. regulatory landscape continues to evolve to ensure data reliability and scientific rigor in drug development, particularly in the growing use of biomarkers. As biomarkers become increasingly critical for evaluating drug safety and efficacy, the FDA has issued specific guidance to standardize how bioanalytical methods for these measurements should be validated. The guidance Bioanalytical Method Validation for Biomarkers was published in April 2026 , providing recom