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Results: 1-10 of 7,346

Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, andor to be relied upon for marketing authorization for pharmaceuticals

Attention to lithium and lithium ion battery safety continues and enforcement increases

  • Wiley Rein LLP
  • -
  • USA
  • -
  • March 25 2008

The safety of lithium cells and batteries recently has been scrutinized by such agencies and organizations as the Consumer Products Safety Commission, U.S. Department of Transportation (DOT), United Nations Subcommittee of Experts on the Transport of Dangerous Goods, International Civil Aviation Organization and International Federation of Air Line Pilots Associations (IFALPA

"Organic" wines - it depends on where you drink it

  • Fox Rothschild LLP
  • -
  • European Union, USA
  • -
  • August 9 2012

If you want to drink organic wine, you will begin finding a much larger selection in Europe with the 2012 vintage

Another medtronic preemption win

  • Dechert LLP
  • -
  • USA
  • -
  • April 20 2011

It's not a complete win, but 8 out of 9 ain't bad

Anti-GMO groups ask Supreme Court to reconsider standing to bring declaratory judgment action against GMO patent holder

  • Baker & Hostetler LLP
  • -
  • USA
  • -
  • September 19 2013

Recently, a group of 73 organic and conventional farmers, seed businesses, and public advocacy groups petitioned the Supreme Court to review the

Supreme Court to hear generic drug labeling issue

  • Edwards Wildman Palmer LLP
  • -
  • USA
  • -
  • December 10 2010

On December 10, 2010, the Supreme Court agreed to hear appeals by Teva Pharmaceutical Industries Ltd., Mylan Inc.'s UDL Laboratories, and Actavis, Inc

Third Circuit finds certain food labeling claims expressly preempted by Food, Drug & Cosmetic Act

  • Barnes & Thornburg LLP
  • -
  • USA
  • -
  • May 23 2013

The U.S. Court of Appeals for the Third Circuit recently issued a non-precedential opinion affirming a finding that alleged food labeling claims

California’s green chemistry law become effective October 1, 2013

  • Seyfarth Shaw LLP
  • -
  • USA
  • -
  • September 30 2013

California's Safer Consumer Product regulations, which implement the state's "Green Chemistry" law, will take effect October 1, 2013. The regulations

Premature development causes unease in China

  • Shook Hardy & Bacon LLP
  • -
  • China, USA
  • -
  • August 20 2010

Chinese health experts have reportedly estimated that "at least 30,000 children developed early maturity" in Shanghai alone, raising concerns about food additives and pesticides allegedly laden with sex hormones

Indiana Court of Appeals: jury to decide whether generic advertising language creates liability for fraud

  • Barnes & Thornburg LLP
  • -
  • USA
  • -
  • September 14 2012

In Kesling v. Hubler, decided on Sept. 4, 2012, the Indiana Court of Appeals ruled that an advertisement could be the basis for intentional fraud claims, creating the possibility for treble damages and punitive damages for conduct that has historically been limited to non-punitive breach of contract damages