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Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority

USA - March 13 2017 At 40, the number of new corporate integrity agreements (CIAs) in 2016 remained in line with the average in recent years, but some important new...

Alexandra M. Gorman, Sydney Sgambato, Michael K. Loucks, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce.


FDA Publications Double Down on Agency's Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate

USA - February 2 2017 On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding...

Alexandra M. Gorman, Michael K. Loucks, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce.


FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate

USA - February 1 2017 On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding...

Alexandra M. Gorman, Michael K. Loucks, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce.


The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

USA - December 13 2016 On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life...

Caroline Van Zile, Alexandra M. Gorman, Michael K. Loucks, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce.


Supreme Court Holds That Violations of the False Claims Act's Seal Requirements Do Not Require Automatic Dismissal

USA - December 7 2016 On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby...

Rene H. DuBois, Alexandra M. Gorman, Michael K. Loucks, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce, Catherine Fisher.