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IRS Denies Tax-Exempt Status to Non-MSSP ACO
  • Jones Day
  • USA
  • April 26 2016

Earlier this month, the IRS released a denial of an exemption application for an accountable care organization ("ACO") outside of the Medicare Shared


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 6
  • Jones Day
  • USA
  • April 14 2016

In early April 2016, FDA finalized the sixth major rule implementing the FDA Food Safety Modernization Act ("FSMA"). This latest rule, "Sanitary


Illinois Creates Health Care Fraud Elimination Task Force
  • Jones Day
  • USA
  • April 12 2016

On April 5, 2016, Illinois Governor Bruce Rauner signed Executive Order 16-05, creating a new Health Care Fraud Elimination Task Force to address


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 2
  • Jones Day
  • USA
  • April 8 2016

Earlier this week, FDA announced the availability of its long-awaited draft guidance on biosimilar labeling, titled "Labeling for Biosimilar Products


Digital Health Law Update, Vol. II, Issue 2
  • Jones Day
  • USA
  • April 6 2016

There is a saying making its way through the insurance marketplace that there are two types of companiesthose that already have purchased a cyber


Fourth Circuit Allows Lanham Act Unfair Competition Claims for Foreign Trademark Not Used in the U.S.
  • Jones Day
  • USA
  • March 30 2016

On March 23, the Fourth Circuit held that the owner of a Mexican trademark could bring false association and false advertising claims under


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 5
  • Jones Day
  • European Union, USA
  • March 24 2016

FDA recently announced a funding opportunity of $19M to states that support the implementation of the Food Safety Modernization Act ("FSMA") Produce


Federal Circuit Upholds Broad Hatch-Waxman Venue Options for Innovator Pharmaceutical Companies
  • Jones Day
  • USA
  • March 22 2016

On March 18, 2016, the United States Court of Appeals for the Federal Circuit issued a combined opinion in Acorda Therapeutics Inc. v. Mylan


Pharmaceutical & Medical Device Regulatory Update Vol. III, Issue 1
  • Jones Day
  • USA
  • March 18 2016

After weeks of opposition, on February 24, 2016, the Senate confirmed Dr. Robert Califf, President Obama's nominee for FDA Commissioner. Although his


Global Privacy & Cybersecurity Update, Issue 9 - March 2016
  • Jones Day
  • Belgium, Brazil, Spain, Taiwan, USA, Hong Kong, Italy, Japan, Mexico, Netherlands, Peru, Canada, China, Colombia, European Union, France, Germany
  • March 17 2016

For decades, EU data protection rules have set some of the world's highest standards of data protection and are currently undergoing significant