On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act...more
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more