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Results: 1-10 of 134

Mobile apps: the FDA publishes its final guidance on regulating mobile medical apps

  • Hodgson Russ LLP
  • -
  • Canada, USA
  • -
  • October 4 2013

Canadian mobile medical app developers will be interested in the FDA's recent guidance on the regulation mobile medical apps in the United States. On

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

The application of the medical device excise tax to foreign manufacturers selling to end-users in the United States

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • May 6 2013

As of January 1, 2013, the first sale of a taxable medical device in the United States by a manufacturer, producer, or importer has been subject to a

Whistleblower suit alleges inflated Medicare reimbursement charges

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • December 8 2011

On November 22, 2011, the Department of Justice announced that it filed a complaint in a False Claims Act case against BestCare Laboratories, Inc. and its founder

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The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?

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

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

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

Teleradiology ghost reading could present False Claims Act issues

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 11 2011

Teleradiology is becoming more and more common

Guidance on HRAs and other employer payment plans

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • November 26 2013

Under ACA for 2014. The Treasury and Department of Labor recently published guidance on the application of the Affordable Care Act Market Reforms on