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DOJ Makes Significant Revisions to Corporate Enforcement Policy

USA - January 20 2023 The U.S. Department of Justice (DOJ) recently announced "the first significant changes" to its Corporate Enforcement Policy (CEP) since…

Wifredo A Ferrer, William F. Gould, Eddie A. Jauregui, Megan Mocho

Oversight and Investigations Related to COVID-19 Pandemic Spending and Federal Programs

USA - April 24 2020 Holland & Knight attorneys and policy professionals provide an overview and analysis of the likely wave of congressional oversight and government…

Christopher J Armstrong, Charles E. Borden, Samuel Brown, Christopher "Chris" DeLacy, Leila S. George-Wheeler, Kelsey M. Hayes, Marissa C Serafino, Robert K. "Bob" Tompkins

Security Assessments May be Part of DoD Government Contracts Acquisition Process

USA - September 17 2018 Identifying threats and improving network and supply chain security has been an ongoing effort by Congress and the Department of Defense (DoD) for the…

David S. Black, Amy L. Fuentes

Second Circuit vacates pharmaceutical misbranding conviction on free speech grounds

USA - January 31 2013 After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that…

Bradley S. Gould

Second Circuit vacates misbranding conviction for pharmaceutical representative on First Amendment grounds

USA - December 6 2012 In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of [a U.S. Food and Drug Administration] FDA-approved drug."

William F. Gould