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FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is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


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


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


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