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FDA approves expanded use of Medtronic’s CoreValve system; also receives regulatory approval in Japan
  • Knobbe Martens
  • USA, Japan
  • April 1 2015

This week the U.S. Food and Drug Administration announced its approval of Medtronic'sCoreValve system for "valve-in-valve" (VIV) replacement


Regulators continue to address radiation concerns
  • Shook Hardy & Bacon LLP
  • USA, Global, Japan
  • March 25 2011

The World Health Organization (WHO), U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) have continued to address public concerns about food produced in Japan, where a recent earthquake and tsunami compromised the Fukushima prefecture’s nuclear power plant, releasing radiation into the atmosphere.


EFSA declines to revise BPA risk assessment
  • Shook Hardy & Bacon LLP
  • European Union, Japan
  • October 1 2010

The European Food Safety Authority’s (EFSA’s) panel on food contact materials, enzymes, flavorings, and processing aids has released its latest risk assessment for bisphenol A, concluding that there was not any “new evidence which would lead them to revise the current Tolerable Daily Intake TDI for BPA of 0.05 mgkg body weight set in its 2006 opinion and re-confirmed in its 2008 opinion.”





Lynn L. Bergeson
  • Bergeson & Campbell PC