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Results: 1-10 of 130

Medical devices offer fertile ground for future whistleblower activity
  • Hodgson Russ LLP
  • USA
  • May 29 2014

Recent gatherings of False Claims Act attorneys who represent whistleblowers, the government, and the defense revealed a consensus


Guidance on HRAs and other employer payment plans
  • Hodgson Russ LLP
  • USA
  • November 26 2013

Under ACA for 2014. The Treasury and Department of Labor recently published guidance on the application of the Affordable Care Act Market Reforms on


Religious employers and the Women’s Contraceptive Mandate
  • Hodgson Russ LLP
  • USA
  • November 26 2013

This past July, the U.S. Departments of Labor, Health and Human Services, and the Treasury released final regulations regarding health plan coverage


FDA issues draft guidance on medical device reporting for manufacturers
  • Hodgson Russ LLP
  • USA
  • September 3 2013

On July 9, 2013, the FDA issued a draft guidance document titled "Medical Device Reporting for Manufacturers." Written in a question and answer


Industry reacts to FDA proposed revisions to acceptance of data from clinical studies for medical devices
  • Hodgson Russ LLP
  • USA
  • July 18 2013

On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical


HHS proposes substantial reinsurance fee
  • Hodgson Russ LLP
  • USA
  • February 28 2013

The Patient Protection and Affordable Care Act (PPACA) establishes, among other things, a transitional reinsurance program to provide payments to


The Physician Payment Sunshine Act final rule: key change from proposed rule affecting foreign entities
  • Hodgson Russ LLP
  • USA
  • June 26 2013

We now have only 36 days to go until August 1, 2013, when the new data collection obligations imposed on "applicable manufacturers" and group


Patent eligible subject matter: USPTO issues interim guidance post-Prometheus
  • Hodgson Russ LLP
  • USA
  • August 8 2012

On July 3, 2012, the U.S. Patent and Trademark Office (USPTO) issued a memorandum setting forth its interim procedures for examination of process claims involving so-called “laws of nature.”


New French Sunshine Act guidance
  • Hodgson Russ LLP
  • France, USA
  • July 11 2013

On June 12, 2013, the French Ministry of Health published Circulaire No. DGSPF22013224 relative to Article 2 of the Law No. 2011-2012 of December


Par pharmaceutical agrees to pay $45M to resolve liability
  • Hodgson Russ LLP
  • USA
  • March 6 2013

According to the Justice Department, Par Pharmaceutical Companies Inc. recently pleaded guilty and agreed to pay $45 million to resolve its liability