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Results: 1-10 of 77

Federal court dismisses strict liability claims against drug maker

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 14 2014

Citing a recent Pennsylvania Supreme Court decision reaffirming a long-standing bar on strict liability claims for prescription drugs under the

FDA plans to finalize generic drug labeling rule by December 2014

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 19 2014

According to the Department of Health and Human Services' semiannual agenda, the U.S. Food and Drug Administration (FDA) plans to issue a final rule

Off-label suture suit against Anulex dismissed as preempted under FDCA

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 19 2014

A North Carolina federal court has dismissed an unfair and deceptive trade practices lawsuit against medical device maker Anulex Technologies, Inc

Public Citizen sues FDA, claims warnings on anti-acid drug are inadequate

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 8 2014

Advocacy organization Public Citizen has sued the U.S. Food and Drug Administration (FDA), seeking a court order requiring the agency to issue a

Vermont House passes amended toxics in consumer products bill

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 8 2014

The Vermont House of Representatives has passed legislation (S. 239) that would givethe state's Health Department the authority to regulate

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

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

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

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

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