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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


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


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

Surviving a medical device recall is no easy feat


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:


Under Park Doctrine, FDA can prosecute individuals for company violations of FDCA
  • Hodgson Russ LLP
  • USA
  • March 18 2011

Since at least 1975, the FDA has had the authority to prosecute responsible corporate officers under the so-called Park Doctrine


Delegation and project management in the clinical trial process
  • Hodgson Russ LLP
  • USA
  • March 11 2011

Adaptive clinical trials in the US are complex exercises in management tasks, social collaboration, and clinical patient care


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


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