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FDA issues plan for improving science
  • Shook Hardy & Bacon LLP
  • USA
  • August 25 2011

The Food and Drug Administration (FDA) has issued its “Strategic Plan for Regulatory Science,” a document deemed to be the agency’s “blueprint for overhauling the science it uses to develop and evaluate food, medicines, and medical devices.”


Sanitizer manufacturers warned about product effectiveness claims
  • Shook Hardy & Bacon LLP
  • USA
  • April 28 2011

The Food and Drug Administration (FDA) has issued warning letters to four companies that make sanitizing products, including first aid gels, mouth wash, antiseptic skin protectants, and hand cleaners and wipes, indicating that the companies' claims render their products "new drugs" under the Food, Drug, and Cosmetics Act, thus requiring that they be approved before marketing, and further are misbranded.


Eighth Circuit rules adulterated drug claims not preempted by federal law
  • Shook Hardy & Bacon LLP
  • USA
  • February 3 2011

The Eighth Circuit Court of Appeals has reinstated claims for economic injury brought against the maker of a hypertension medication, finding that allegations of adulteration and failure to comply with federal regulations were not impliedly preempted by the Federal Food, Drug, and Cosmetic Act.


Federal court dismisses OTC drug litigation; reliance on agency warning letter misplaced
  • Shook Hardy & Bacon LLP
  • USA
  • September 16 2010

A federal court in Ohio has dismissed with prejudice a putative class action alleging that promotions for over-the-counter (OTC) cold- and flu-symptom relief products with vitamin C were false or misleading and violated state consumer protection laws.


Federal court rules coalition lacks standing to force FDA to stop allowing thimerosal in pharmaceuticals
  • Shook Hardy & Bacon LLP
  • USA
  • July 22 2010

A federal court in the District of Columbia has determined that an organization opposed to the use of mercury-based preservatives, such as Thimerosal, in vaccines, lacks standing to challenge in court the Food and Drug Administration's (FDA's) denial of its citizen petition seeking to ban the use of Thimerosal in pharmaceutical products, including vaccines.


FDA orders recall and destruction of infusion pumps
  • Shook Hardy & Bacon LLP
  • USA
  • May 13 2010

The Food and Drug Administration (FDA) has ordered a medical device manufacturer to recall and destroy some 200,000 infusion pumps currently in use in hospitals and health care clinics to accurately deliver fluids, such as nutrients and medications, into a patient's body.