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, John T. Bentivoglio, Maya P. Florence, 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, John T. Bentivoglio, Maya P. Florence, 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, John T. Bentivoglio, Maya P. Florence, Jennifer L. Bragg, Gregory M. Luce.
Republicans Chart New Course for US Health Care System
USA - January 28 2017 While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details...
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, John T. Bentivoglio, Maya P. Florence, Jennifer L. Bragg, Gregory M. Luce.
