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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


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 5
  • Jones Day
  • USA
  • July 13 2016

On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for


Federal Circuit Decision Clarifies Application of On-Sale Bar to Third-Party Manufacturers and Suppliers
  • Jones Day
  • USA
  • July 13 2016

On July 11, 2016, in The Medicines Company v. Hospira, Inc., the Federal Circuit issued a rare unanimous en banc opinion addressing the circumstances


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


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 10
  • Jones Day
  • Cuba, European Union, USA
  • July 12 2016

On June 23, 2016, Senator Pat Roberts (R-Kansas) and Senator Debbie Stabenow (D-Michigan) reached an agreement to solve the state-by-state labeling


EEOC Issues Final Wellness Plan Regulations and Immediately Asserts Retroactive Effect
  • Jones Day
  • USA
  • July 6 2016

On May 16, 2016, the Equal Employment Opportunity Commission ("EEOC") finalized highly anticipated regulations that purport to define the extent to


Supreme Court Decides Validity of False Implied Certification Theory in Universal Health Services v. Escobar
  • Jones Day
  • USA
  • June 17 2016

On June 16, 2016, the U.S. Supreme Court decided Universal Health Services v. United States ex rel. Escobar, a widely anticipated decision with


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 9
  • Jones Day
  • European Union, USA
  • June 17 2016

FDA has published its last major regulation implementing the Food Safety and Modernization Act ("FSMA"): a final rule on mitigation strategies to


Digital Health Law Update, Vol. II, Issue 3
  • Jones Day
  • USA
  • June 15 2016

The U.S. Senate Committee for Health, Education, Labor and Pensions, known as HELP, recently passed its marked version of the Medical Electronic Data


Global Privacy & Cybersecurity Update, Issue 10 - June 2016
  • Jones Day
  • Australia, European Union, France, United Kingdom, USA
  • June 6 2016

The complicated fabric of privacy and data security regulations in Asia continues to challenge multinational clients. The last few months have seen