FDA Revises Drug Approval Process to Require Only One Clinical TrialThu 19th Feb, 2026The United States Food and Drug Administration (FDA) has announced a significant change to its drug approval framework. Under the revised guidelines, a single robust clinical trial demonstrating efficacy will now be the main requirement for market authorization. The FDA's updated policy emphasizes the value of scientifically sound alternatives to traditional clinical studies, leveraging advancements in biomedical research and drug development methodologies. The FDA maintains that the revised approval process will uphold rigorous standards for safety and efficacy, emphasizing that the quantity of studies does not inherently guarantee higher quality. Some critics have expressed apprehension that lowering the number of required clinical studies could increase the risk of ineffective or unsafe therapies reaching the market.

Source: The Munich Eye February 19, 2026 21:17 UTC