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French company prevails in dispute with FDA over drug-classification ruling

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements

Biopharma co. seeks $90 million for tainted raw material from China

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 3 2012

A biopharmaceutical company has sued companies in its supply chain, alleging they were negligent or vicariously liable for obtaining from China a raw material, contaminated with beef broth and avian products, for use in the creation of a bacterial master cell bank for the production of a biologic drug that will be used in patients with acute spinal cord injury

In-house counsel survey suggests biotech mass torts will increase

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 29 2012

Thousands of in-house counsel, surveyed over 11 years by BTI Consulting Group, are reportedly predicting that more class action attorneys with technological know-how will be needed in coming years because of an anticipated increase in chemical and biotech mass tort litigation

Dialysis equipment maker sues component part supplier for indemnification

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 17 2011

A company that makes dialysis equipment for use in clinics and by patients in their homes has filed a complaint in federal court against a company that supplied a component part which allegedly contained a defect that led to a recall and caused injuries and at least one death

Adequacy of generic drug warnings on U.S. Supreme Court agenda

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 7 2011

The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA

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