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Results: 1-10 of 134

Government statistics show upward trend in False Claims Act settlements
  • Hodgson Russ LLP
  • USA
  • January 31 2012

Data released by the U.S. Department of Justice reveal a substantial increase in False Claims Act recoveries over the past two years


FDA's final rule for combination products
  • Hodgson Russ LLP
  • USA
  • January 29 2013

On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable


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


Failure to notify participant that coverage is out of network may be a fiduciary breach
  • Hodgson Russ LLP
  • USA
  • January 31 2014

The U.S. Court of Appeals for the Seventh Circuit, in an en banc decision, held that the husband of a deceased plan participant may continue with his


American Sleep Medicine to pay more than $15.3m to resolve allegations of Medicare fraud
  • Hodgson Russ LLP
  • USA
  • February 7 2013

The federal government recently settled a $15 million False Claims Act (FCA) case against American Sleep Medicine LLC, according to a recent Justice


New COBRA subsidy rules
  • Hodgson Russ LLP
  • USA
  • March 19 2010

The Temporary Extension Act of 2010 (TEA), signed into law by President Obama on March 2, 2010, includes a number of important changes to the COBRA premium subsidy provisions enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA


New Obamacare guidance
  • Hodgson Russ LLP
  • USA
  • July 31 2013

The Departments of Labor, Health and Human Services, and the Treasury have issued more Frequently Asked Questions (FAQs) regarding implementation


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


FDA regulation of medical devices: hot topics and recent news
  • Hodgson Russ LLP
  • USA
  • July 9 2012

Here are a few recent topics of interest to the medical device industry:


European Commission's roadmap for the recast of three medical devices directives
  • Hodgson Russ LLP
  • European Union
  • August 15 2012

In the 1990s, the European Union (EU) regulation of medical devices across the European Economic Area (EEA) was harmonized under three medical device directives