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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


Agencies issue amendments to the PPACA claims and appeals processes
  • Hodgson Russ LLP
  • USA
  • July 29 2011

The Treasury, DOL, and the Department of Health and Human Services jointly issued amendments to the interim final rules governing the internal claims and appeals and the external review processes required under the Patient Protection and Affordable Care Act (PPACA


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


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


How to avoid import detention by the FDA
  • Hodgson Russ LLP
  • USA
  • August 3 2011

An import detention notice from the FDA is received by many importers of foreign goods with mixed feelings of surprise, confusion, and anxiety


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


MEWA held to be not fully insured under ERISA
  • Hodgson Russ LLP
  • USA
  • April 15 2011

When unrelated employers join together in an association or other group to purchase or arrange for health insurance, the association is defined as a "multiple employer welfare arrangement" or "MEWA" under the law


NYS Legislature establishes state Justice Center for the Protection of People With Special Needs
  • Hodgson Russ LLP
  • USA
  • August 26 2013

The Justice Center for the Protection of People With Special Needs opened on June 30, 2013. The center, established by the Protection of People with


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


The Physician Payment Sunshine Act final rule: key change from proposed rule affecting foreign entities
  • Hodgson Russ LLP
  • USA
  • June 26 2013

We now have only 36 days to go until August 1, 2013, when the new data collection obligations imposed on "applicable manufacturers" and group