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Proposed regulations issued for excepted benefits

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • February 28 2014

The Departments of the Treasury, Labor, and Health and Human Services recently issued proposed regulations that generally expand the definition of

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 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

Patent eligible subject matter: USPTO issues interim guidance post-Prometheus

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • August 8 2012

On July 3, 2012, the U.S. Patent and Trademark Office (USPTO) issued a memorandum setting forth its interim procedures for examination of process claims involving so-called “laws of nature.”

Failure to notify participant that coverage is out of network may be a fiduciary breach

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 31 2014

The U.S. Court of Appeals for the Seventh Circuit, in an en banc decision, held that the husband of a deceased plan participant may continue with his

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

FDA and European Medicines Agency to do parallel evaluation of new drug marketing applications

  • Hodgson Russ LLP
  • -
  • European Union, USA
  • -
  • April 4 2011

FDA is always criticized and questioned about taking longer to approve regulated products than its counterpart agency in Europe, European Medicines Agency (EMA

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

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:

Agencies issue new FAQS regarding Affordable Care Act preventive care issues

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • April 30 2013

The Departments of Labor, Health, and Human Services and the Treasury have once again issued a set of FAQs regarding the implementation of the