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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


Global Privacy & Cybersecurity Update Vol. 11 - September 2016
  • Jones Day
  • Australia, European Union, France, USA
  • September 12 2016

Multinational companies have faced new developments over the past year in the area of EU data protection law, from the invalidation of the U.S.-EU


Global privacy & data security update vol. 11 - September 2016
  • Jones Day
  • Australia, European Union, France, USA
  • September 12 2016

Multinational companies have faced new developments over the past year in the area of EU data protection law, from the invalidation of the U.S.-EU


New Private Use Safe Harbors for Tax-Exempt Hospitals and Other Qualified Users: New Flexibility, New Restrictions, and Open Questions
  • Jones Day
  • USA
  • September 8 2016

New safe harbor guidelines released by the IRS on August 22, 2016 (Rev. Proc. 2016-44) are likely to have a significant impact on a variety of


Affordable Care Act Drug "Test" is Thin Cover for More Obamacare Executive Overreach, Forbes
  • Jones Day
  • USA
  • August 18 2016

The Affordable Care Act ("ACA," "the Act") has overwhelmed large swaths of the economy, and the Administration is poised to upend yet another, by


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 11
  • Jones Day
  • Brazil, European Union, USA
  • August 12 2016

On July 29, 2016, President Obama signed into law S.764, the bill that creates the "National Bioengineered Food Disclosure Standard." As discussed in


Digital Health Law Update, Vol. II, Issue 4
  • Jones Day
  • USA
  • August 8 2016

On May 18, 2016, the Department of Health and Human Services ("HHS") issued a final rule implementing Section 1557 of the Patient Protection and


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 6
  • Jones Day
  • European Union, United Kingdom, USA
  • August 3 2016

FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is


Post-Spokeo Decisions Rejecting "No Injury" Lawsuits
  • Jones Day
  • USA
  • July 15 2016

Multiple recent decisions have applied the U.S. Supreme Court's injury-in-fact analysis from Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016), to


180-Day Notice of Commercial Marketing Mandatory Even When Biosimilar Applicants Do the "Patent Dance"
  • Jones Day
  • USA
  • July 13 2016

On July 5, 2016, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition