Craig Bleifer

McGuireWoods LLP

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First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard

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

3/5/2025 / Anti-Kickback Statute , Appeals , Causation , Department of Justice (DOJ) , False Claims Act (FCA) , Healthcare Fraud , Medicare , Pharmaceutical Industry , Relators

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

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

1/30/2025 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC , New Guidance , Pharmaceutical Industry

Dairy Industry Alerted to New USDA Order Requiring National Raw Milk Testing

In response to an outbreak of the H5N1 strain of bird flu among dairy cows in at least 15 states, the U.S. Department of Agriculture (USDA) issued a new federal order (the Order) requiring dairy farms and other entities...more

12/11/2024 / Dairy Farmers , Department of Health and Human Services (HHS) , Food Manufacturers , Food Safety , Food Supply , USDA

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