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Results: 1-10 of 134

Mobile apps: the FDA is on its path of enforcement actions

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 24 2013

Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No

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

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

FDA's final rule for combination products

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 29 2013

On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable

Teleradiology ghost reading could present False Claims Act issues

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

Teleradiology is becoming more and more common

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

Government statistics show upward trend in False Claims Act settlements

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 31 2012

Data released by the U.S. Department of Justice reveal a substantial increase in False Claims Act recoveries over the past two years

Notice 2012-59 90 day waiting period limitation

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • September 28 2012

For plan years beginning on or after January 1, 2014, a group health plan or health insurance issuer may not use a waiting period that exceeds 90 days

Final rules: essential health benefits, cost-sharing, and actuarial value

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • May 31 2013

Beginning in 2014, non-grandfathered individual health insurance policies and policies issued to small employers must provide "essential health