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Results: 1-10 of 134

FDA issues draft guidance on medical device reporting for manufacturers
  • Hodgson Russ LLP
  • USA
  • September 3 2013

On July 9, 2013, the FDA issued a draft guidance document titled "Medical Device Reporting for Manufacturers." Written in a question and answer


Health Care False Claims Act settlements increasing
  • Hodgson Russ LLP
  • USA
  • March 21 2012

March 1, 2012, was a big day for New York State taxpayers, as both the state and federal governments announced significant settlements impacting the state


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


Can personal injury lawyers be liable to medical plans?
  • Hodgson Russ LLP
  • USA
  • October 31 2013

The U.S. District Court for the Eastern District of New York recently held that a medical plan can enforce a lien against attorneys' fees received in


Vermont cannot require ERISA plans to report claims data
  • Hodgson Russ LLP
  • USA
  • April 30 2014

In October 2011, the State of Vermont enacted a statute requiring the establishment and maintenance of a unified health care database designed to


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The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?


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


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

Teleradiology is becoming more and more common


U.S. government accountability office update on FDA medical device oversight
  • Hodgson Russ LLP
  • USA
  • April 21 2011

On April 13, 2011, the United States Government Accountability Office (GAO) testified before the Senate Special Committee on Aging regarding FDA's regulation of high-risk medical devices


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: