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Food, Dietary Supplement & Cosmetics Regulatory Update Vol. III, Issue 15
  • Jones Day
  • European Union, USA
  • November 19 2016

This month, in the middle of the renewal period for registration of food facilities, FDA has published the seventh edition of its draft guidance


The Future of the Affordable Care Act
  • Jones Day
  • USA
  • November 16 2016

President-elect Trump has made revamping our health care system a top priority for his new administration. He has been clear that action needs to be


PTAB Upholds Patent Claims on Methods of Using Ravicti
  • Jones Day
  • USA
  • November 11 2016

On November 3, 2016, the PTAB issued a Final Written Decision upholding a Horizon Therapeutics LLC (“Horizon”) patent, U.S. 8,642,012 (the ’012


Digital Health Law Update, Vol. II, Issue 5
  • Jones Day
  • USA
  • November 7 2016

The Americans with Disabilities Act of 1990, 42 U.S.C. 12101 et seq. ("ADA" or "Act"), is one of several important federal laws defining whether


PTAB Declines to Institute IPR Proceedings Against Three Biogen TYSABRI Formulation Patents
  • Jones Day
  • USA
  • November 2 2016

On October 17, 2016, the PTAB declined the requests of Swiss Pharma International AG (“Swiss Pharma”) in cases IPR2016-00912, IPR2016-00915, and


PTAB Invalidates Patent Claims on Gattex Formulation
  • Jones Day
  • USA
  • October 28 2016

On October 21, 2016, the PTAB issued two final written decisions in cases IPR2015-00990 and IPR2015-01093, invalidating claims 1-27, 31-40, 44-52 and


Food, Dietary Supplement & Cosmetics Regulatory Update Vol. III, Issue 14
  • Jones Day
  • European Union, USA
  • October 28 2016

Read the full Food, Dietary Supplement & Cosmetics Regulatory Update. Top News FDA Answers Questions on Compliance Dates for Nutrition Initiatives On


Beyond Rum and Cigars: Further Easing of Sanctions Paves Way for Increased Business Opportunities in Cuba
  • Jones Day
  • Cuba, USA
  • October 19 2016

On October 17, 2016, the U.S. government further eased the economic sanctions and trade embargo against Cuba to implement the administration's policy


Food, Dietary Supplement & Cosmetics Regulatory Update Vol. III, Issue 13
  • Jones Day
  • European Union, OECD, USA
  • October 6 2016

On September 28, 2016,FDA announced it has started a public process to redefine the "healthy" nutrient content claim for food labeling. On December 1


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 7
  • Jones Day
  • USA
  • September 21 2016

On November 9 and 10, 2016, FDA will host a public hearing to obtain feedback on the Agency's regulation of communications by manufacturers, packers