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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

Proposed wellness plan legislation responds to lawsuits filed by EEOC

  • Jones Day
  • -
  • USA
  • -
  • March 19 2015

The United States House of Representatives' Education and the Workforce Committee will conduct a hearing on March 24, 2015 about the House version of

Pharmaceutical & medical device regulatory update, vol. II, issue 5

  • Jones Day
  • -
  • USA
  • -
  • March 13 2015

On March 6, 2015, FDA approved Zarxio (filgrastim-sndz), the first biosimilar product to be approved in the United States under the Biologics Price

New Dietary Guidelines Advisory Report: eggs and coffee are back, but sugar is out

  • Jones Day
  • -
  • USA
  • -
  • March 11 2015

On February 19, 2015, a group of 14 outside experts who formed the 2015 Dietary Guidelines Advisory Committee ("Committee") released the Scientific

Protecting your hospital's tax-exempt status: compliance with the Affordable Care Act and final IRS Section 501(r) regulations

  • Jones Day
  • -
  • USA
  • -
  • March 11 2015

The Patient Protection and Affordable Care Act (the "Affordable Care Act") imposes four new requirements that Section 501(c)(3) "hospital

Supreme Court requires state supervision of professional boards to secure antitrust immunity

  • Jones Day
  • -
  • USA
  • -
  • March 6 2015

In an important decision, the U.S. Supreme Court has held that, where a state professional regulatory board is controlled by active market

Food, dietary supplement & cosmetics regulatory update, vol. II, issue 5

  • Jones Day
  • -
  • European Union, United Kingdom, USA
  • -
  • March 5 2015

The Dietary Guidelines Advisory Committee ("DGAC") recently released the Scientific Report of the 2015 Dietary Guidelines for Americans (the "Advisory

Pharmaceutical & medical device regulatory update, vol. II, issue 4

  • Jones Day
  • -
  • USA
  • -
  • February 26 2015

FDA recently issued five new documents related to drug compounding and repackaging to provide compliance information to pharmacies, physicians, and

HHS announces new payment initiative designed to encourage better oncology care

  • Jones Day
  • -
  • USA
  • -
  • February 26 2015

On February 12, 2015, the U.S. Department of Health and Human Services ("HHS") announced the Oncology Care Model ("OCM"), a new initiative sponsored