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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

Pharmaceutical & medical device regulatory update, issue 18

  • Jones Day
  • -
  • USA
  • -
  • November 7 2014

Last week, Amgen filed a complaint in federal court against Sandoz, the first domestic biosimilar applicant that seeks to issue a biosimilar version

FDA voices privacy concerns and promotes medical device cybersecurity with new guidance, collaborative information-sharing

  • Jones Day
  • -
  • USA
  • -
  • November 6 2014

FDA recently issued guidance on cybersecurity requirements for premarket submissions of medical devices and held a two-day workshop among

CMS announces new initiative designed to support clinicians in developing comprehensive quality improvement strategies

  • Jones Day
  • -
  • USA
  • -
  • October 31 2014

On October 23, 2014, the Centers for Medicare & Medicaid Services ("CMS")announced the Transforming Clinical Practice Initiative ("TCPI"), a new

Food, dietary supplement & cosmetics regulatory update, issue 17

  • Jones Day
  • -
  • USA
  • -
  • October 31 2014

Earlier this month, the Center for Food Safety ("CFS") announced it had reached a settlement agreement with FDA requiring the agency to finalize the