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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FDA issues draft guidance on medical device reporting for manufacturers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On July 9, 2013, the FDA issued a draft guidance document titled "Medical Device Reporting for Manufacturers."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


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


Departments issue wellness program final regulations
  • Hodgson Russ LLP
  • USA
  • July 31 2013

The Departments of Health and Human Services, Labor, and Treasury issued final wellness program regulations. These final rules are applicable to


New French Sunshine Act guidance
  • Hodgson Russ LLP
  • USA, France
  • 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


Lifewatch Services to pay $18.5m to resolve False Claims Act allegations
  • Hodgson Russ LLP
  • USA
  • April 5 2012

The U.S. Department of Justice recently announced an $18.5 million False Claims Act settlement in a case brought by two whistleblowers against LifeWatch Services Inc., an Illinois-based company


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:


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

Surviving a medical device recall is no easy feat


Premarket notification (510k), Pt. i: ownership and licensing
  • Hodgson Russ LLP
  • USA
  • March 21 2011

We are often asked by our clients about the transfer of the FDA marketing approvals from one entity to another


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

Teleradiology is becoming more and more common