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FDA modifies list of recognized standards

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 6 2014

The U.S. Food and Drug Administration (FDA) has announced the availability of its publication, "Modifications to the List of Recognized Standards

Biomedical device maker enters plea, failed to provide information to FDA

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 6 2014

San Diego-based Valor Medical, Inc., a biomedical device manufacturer, and four of its employees have reportedly pleaded guilty to counts of failing

Eighth Circuit finds no error in jaw disease verdict

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 16 2014

While the Eighth Circuit Court of Appeals has affirmed a $225,000 jury award to the estate of a woman who developed osteonecrosis of the jaw (ONJ

FDA seeks to create labeling parity for generic drug makers

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 27 2013

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would speed the dissemination of new safety information about generic

Court finds no error in remedy for inconsistent jury verdict in drug-warning case

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 27 2013

Rejecting the defendant's claim that a new trial should have been ordered when the jury initially returned an inconsistent verdict, a federal court

ASTM Committee agrees to develop voluntary standard for adult portable bed rails

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 27 2013

A newly formed ASTM committee has reportedly agreed to establish a voluntary standard for adult portable bed rails. Committee members, including

SCOTUS rules design-defect claims involving generic drugs are preempted

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 27 2013

The U.S. Supreme Court, in a 5-4 ruling, has determined that state-law design-defect claims that "turn on" the adequacy of a generic drug's warnings

FDA proposes regulations for stand-alone symbols on medical devices

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 25 2013

The Food and Drug Administration (FDA) has proposed revising medical device and biological product labeling regulations "to explicitly allow for the

Dietary supplement class stayed pending settlement in related litigation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 11 2013

Because a virtually identical class action pending before a state court is near settlement, a federal court in California has agreed, in the interest

Vermont lawmakers vote to ban flame-retardant chemicals

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 11 2013

Vermont state senators have voted unanimously in support of legislation (S. 81) that would ban the use of certain purportedly toxic flame-retardant