Navigating the New Era of FDA BIMO Enforcement and Sponsor Accountability

The U.S. Food and Drug Administration’s Bioresearch Monitoring (BIMO) program has entered a new phase of enforcement maturity. Once viewed primarily as a pharmaceutical oversight mechanism, BIMO has expanded into a robust compliance program that now actively scrutinizes clinical research in the food and dietary supplement sectors. Sponsors can no longer assume that non-drug studies fall outside the FDA’s enforcement scope….download for more.