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As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

USA - January 23 2018 The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the...

John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce.


A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

USA - December 5 2017 On November 14, 2017, Skadden hosted its Seventh Annual Pharmaceutical and Medical Device Seminar in New York City, which focused on U.S. enforcement...

Mitchell S. Ettinger, Warren Feldman, Alexandra M. Gorman, John T. Bentivoglio, Jennifer L. Bragg, Colleen P. Mahoney, Maya P. Florence, Avia M. Dunn.


Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

USA - September 28 2017 On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S...

Alexandra M. Gorman, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce, Maya P. Florence, Avia M. Dunn.


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, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce, Maya P. Florence, Sydney Sgambato.


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, John T. Bentivoglio, Jennifer L. Bragg, Gregory M. Luce, Maya P. Florence.