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FDA Issues Final Guidance on Clinical Decision Support Software

USA - October 21 2022 On September 28, 2022, the U.S. Food and Drug Administration issued a final guidance regarding how FDA classifies different kinds of clinical…

Sean K. Burke, Coleen W. Hill

DOJ Announces an Enhanced Approach to Corporate Criminal Enforcement

USA - October 17 2022 On September 15, 2022, Deputy Attorney General Lisa O. Monaco of the Department of Justice (DOJ) delivered a speech at New York University addressing…

Eric R. Breslin, Brittany Pagnotta

FDA Issues Guidance on the Background and Evaluation of Therapeutic Equivalence Codes

USA - August 4 2022 In July 2022, FDA published guidance to industry regarding its therapeutic equivalence evaluations, including the assignment of therapeutic…

Patrick C. Gallagher, Irfan Hassam-Malani

FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising

USA - June 28 2022 The Federal Trade Commission (FTC) has announced proposed changes to its Endorsement Guides, 16 CFR Part 255, which assist entities in conforming…

Patrick C. Gallagher, Coleen W. Hill

DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability

USA - June 27 2022 On June 3, 2022, the Washington, D.C., office of the Civil Division of the Department of Justice (DOJ) filed a statement of interest in a relator's…

Eric R. Breslin, Brittany Pagnotta