We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 134

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


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


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


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


Recall: prevent, manage, mitigate, and survive
  • Hodgson Russ LLP
  • USA
  • February 28 2011

Surviving a medical device recall is no easy feat


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


Utilizing the concurrent de novo review
  • Hodgson Russ LLP
  • USA
  • October 11 2011

The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?


Legal challenges to health care reform continue to work through the courts
  • Hodgson Russ LLP
  • USA
  • April 15 2011

In late January, a district court in Florida ruled that the Patient Protection and Affordable Care Act (PPACA) is unconstitutional