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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


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


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


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


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:


FDA issues draft guidance on medical device reporting for manufacturers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On July 9, 2013, the FDA issued a draft guidance document titled "Medical Device Reporting for Manufacturers."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


Issues facing foreign exporters: finding an initial distributor
  • Hodgson Russ LLP
  • USA
  • October 24 2011

Companies that manufacture medical devices abroad (considered “foreign exporters” by the FDA) face a number of regulatory hurdles if they want to market their products in the U.S


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


The Physician Payment Sunshine Act: reporting obligations and achieving compliance
  • Hodgson Russ LLP
  • USA
  • April 17 2012

Many device and drug manufacturers may not be aware of the upcoming requirements to collect data on payments made to physicians or teaching hospitals in 2012 and report them to the Centers for Medicare and Medicaid Services (CMS) in 2013


Premarket notification (510k), Pt. II: transfer
  • Hodgson Russ LLP
  • USA
  • March 24 2011

A 510(k) may be bought, sold, or transferred