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OIG 2017 Work Plan Lists New Enforcement Priorities
  • Arent Fox LLP
  • USA
  • November 29 2016

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for Fiscal Year 2017 (2017 Work


US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetryMedNet
  • Arent Fox LLP
  • USA
  • November 29 2016

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its


FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • Arent Fox LLP
  • USA
  • November 28 2016

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which is available


Podcast: What's Next For Obamacare (Part II)
  • Arent Fox LLP
  • USA
  • November 22 2016

With President-elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In


Podcast: What's Next For Obamacare (Part I)
  • Arent Fox LLP
  • USA
  • November 22 2016

With President-Elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In


FDA Announcement on Guidance for Industry, Generic Drug User Fee Amendments of 2012
  • Arent Fox LLP
  • USA
  • November 22 2016

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions


Key Issues for the California Cannabis Industry
  • Arent Fox LLP
  • USA
  • November 21 2016

In the wake of the legalization of cannabis in the State of California following last week’s election, it is important for businesses to take stock


CMS Published the Covered Outpatient Drug Final Rule
  • Arent Fox LLP
  • USA
  • November 16 2016

On Monday, CMS issued a notice that, in effect, gives drug manufacturers a three-year reprieve to updating their systems to include sales in US


Election analysis
  • Arent Fox LLP
  • OECD, USA
  • November 9 2016

This election has produced a stunning result surprising the pundits, pollsters and many Americans. Despite the often


Supreme Court Unlikely to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement
  • Arent Fox LLP
  • USA
  • November 8 2016

On November 1, 2016, the Supreme Court heard argument in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby, a False Claims Act case in