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Pharmaceutical & medical device regulatory update, vol. II, issue 9
  • Jones Day
  • USA
  • May 7 2015

FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of


Digital health law update, vol. I, issue 2
  • Jones Day
  • USA
  • April 28 2015

With investment in digital health start-ups growing exponentially in recent years, it is important that interested parties proceed with a


Texas Attorney General settles alleged boycott case
  • Jones Day
  • USA
  • April 27 2015

The Texas Attorney General has settled its challenge to an agreement among sellers of dental supplies that, in the State's view, prevented


Pharmaceutical & medical device regulatory update, vol. II, issue 8
  • Jones Day
  • European Union, USA
  • April 24 2015

The first U.S. biosimilar product Zarxio overcame another legal challenge earlier this month when a federal court in California denied a motion to


Defining the bounds of the public disclosure bar and the scope of "news media"
  • Jones Day
  • USA
  • April 15 2015

On March 3, 2015, a court in the Southern District of Texas granted a defendant pharmaceutical company's motion for summary judgment on claims


Pharmaceutical & medical device regulatory update, vol. II, issue 7
  • Jones Day
  • USA
  • April 10 2015

Last week, Margaret A. Hamburg completed a nearly six-year stint as FDA Commissioner. In a departing interview with National Public Radio, Hamburg


HHS announces Next Generation ACO model of payment and care delivery
  • Jones Day
  • USA
  • April 6 2015

On March 10, 2015, the U.S. Department of Health and Human Services ("HHS") announced the Next Generation Accountable Care Organization Model ("Next


Digital health law update - an overview of notable happenings affecting digital health, mobile health, and telemedicine, volume I, issue I
  • Jones Day
  • USA
  • March 30 2015

In the face of increasing demands to improve the convenience and accessibility of health care while also controlling costs, health care providers are


Pharmaceutical & medical device regulatory update, vol. II, issue 6
  • Jones Day
  • USA
  • March 27 2015

A federal court in California has ruled that under the Biologics Price Competition and Innovation Act ("BPCI Act") a biosimilar applicant is not


Supreme Court clarifies liability standard for opinions expressed in registration statements
  • Jones Day
  • USA
  • March 26 2015

On March 24, 2015, the United States Supreme Court clarified the circumstances under which a company can be liable under 11 of the Securities Act