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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

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

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

Pharmaceutical & medical device regulatory update, vol. II, issue 3

  • Jones Day
  • -
  • USA
  • -
  • February 13 2015

Dr. Margaret Hamburg has announced she will resign from her post as FDA Commissioner in March 2015, citing her long service to the Agency and the

Pharmaceutical & medical device regulatory update, vol. II, issue 2

  • Jones Day
  • -
  • USA
  • -
  • January 29 2015

President Obama Paid Special Attention To Medical Innovation During His State Of The Union Address last week when he highlighted a "precision

Pharmaceutical & medical device regulatory update, vol. II, issue 1

  • Jones Day
  • -
  • USA
  • -
  • January 15 2015

As part of its MDUFA III negotiations with industry, FDA agreed to publish and seek feedback on an annual list of prioritized draft and final

Pharmaceutical & medical device regulatory update, issue 20

  • Jones Day
  • -
  • USA
  • -
  • December 22 2014

This week, the U.S. Department of Justice ("DOJ") indicted 14 owners and senior officials of a Massachusetts pharmacy that manufactured and

Jury finds for drug manufacturers in first post-Actavis "reverse payment" trial

  • Jones Day
  • -
  • USA
  • -
  • December 11 2014

In the first "reverse payment" trial since the U.S. Supreme Court’s Actavis decision held that "reverse payment" settlements potentially could be

2015 HHS OIG Work Plan focuses on payment accuracy, privacy concerns, and insurance marketplaces

  • Jones Day
  • -
  • USA
  • -
  • November 19 2014

On October 31, 2014, the Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") published its Work Plan for Fiscal Year

Pharmaceutical & medical device regulatory update, issue 19

  • Jones Day
  • -
  • USA
  • -
  • November 18 2014

The Justice Department is investigating generic drug companies for potential violations of antitrust laws related to sudden spikes in prices for what