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Clinical trial financial disclosure: French legislation
  • Hodgson Russ LLP
  • France
  • September 6 2011

The European Parliament and Council’s Directive 200120EC dated April 4, 2001, which has been modified several times, is related to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use


Decree on advertising medical devices in France
  • Hodgson Russ LLP
  • France
  • August 27 2012

A new French law wants to strengthen the safety of drugs and medical products


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


MEWA held to be not fully insured under ERISA
  • Hodgson Russ LLP
  • USA
  • April 15 2011

When unrelated employers join together in an association or other group to purchase or arrange for health insurance, the association is defined as a "multiple employer welfare arrangement" or "MEWA" under the law


Teleradiology ghost reading could present False Claims Act issues
  • Hodgson Russ LLP
  • USA
  • July 11 2011

Teleradiology is becoming more and more common


St. Jude Medical pays $3.65 million to settle overcharge claims
  • Hodgson Russ LLP
  • USA
  • June 1 2012

St. Jude Medical Inc. has settled, for $3.65 million, federal False Claim Act allegations arising from a qui tam case in which the relators alleged that the company inflated the cost of replacement pacemakers and defibrillators purchased by the Departments of Defense and Veterans Affairs, the U.S. Department of Justice announced recently


Commission recommendation: unique device identification (UDI)
  • Hodgson Russ LLP
  • European Union
  • August 10 2012

A proposed rule issued by the FDA pertaining to the unique device identification system likely foreshadows its mandatory implementation, as it is aimed at establishing compatible traceability systems between member states of the European Union


Developments in medical device industry may bring big change
  • Hodgson Russ LLP
  • USA
  • August 1 2011

On July 26, 2011, the FDA released a much anticipated revision to the medical device guidance document "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."


US fiscal cliff resolution
  • Hodgson Russ LLP
  • USA
  • February 25 2013

On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act (H.R. 8) effective January 1, 2013. The act was the culmination


Proposed regulations issued for excepted benefits
  • Hodgson Russ LLP
  • USA
  • February 28 2014

The Departments of the Treasury, Labor, and Health and Human Services recently issued proposed regulations that generally expand the definition of