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Results: 1-10 of 134

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


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


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


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


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

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


Developments in medical device industry may bring big change
  • Hodgson Russ LLP
  • USA
  • August 1 2011

On July 26, 2011, the FDA released a much anticipated revision to the medical device guidance document "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."


New guidance regarding the age-26 dependent coverage mandate
  • Hodgson Russ LLP
  • USA
  • May 28 2010

Under the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, group health plans that extend coverage to dependent children must continue to make such coverage available until age 26


New guidance regarding preventive services, cost sharing, and wellness
  • Hodgson Russ LLP
  • USA
  • March 31 2014

On January 9, 2014, the Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the "Departments") issued


Medical plan preauthorization language violates SPD standards
  • Hodgson Russ LLP
  • USA
  • August 29 2012

In Koehler v. AETNA Health Inc., the U.S. Court of Appeals for the Fifth Circuit held that Aetna’s benefits decision was not, as a matter of law, entitled to deference where the same document, Aetna’s certificate of coverage, served as both the plan document and summary plan description (SPD