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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


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


The application of the medical device excise tax to foreign manufacturers selling to end-users in the United States
  • Hodgson Russ LLP
  • USA
  • May 6 2013

As of January 1, 2013, the first sale of a taxable medical device in the United States by a manufacturer, producer, or importer has been subject to a


Mobile apps: the FDA publishes its final guidance on regulating mobile medical apps
  • Hodgson Russ LLP
  • Canada, USA
  • October 4 2013

Canadian mobile medical app developers will be interested in the FDA's recent guidance on the regulation mobile medical apps in the United States. On


Mobile apps: the FDA is on its path of enforcement actions
  • Hodgson Russ LLP
  • USA
  • July 24 2013

Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No


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


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


Employer not penalized for failing to provide timely COBRA notice
  • Hodgson Russ LLP
  • USA
  • March 31 2014

The U.S. District Court for the Northern District of Iowa held that a family, mistakenly receiving almost a year's worth of free employer coverage


Sunshine Act data collection checklist
  • Hodgson Russ LLP
  • USA
  • August 13 2013

As we discussed in an earlier post, the data collection obligations under the Physician Payment Sunshine Act commenced on August 1, 2013, and all


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