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Results: 1-10 of 196

Privacy & cybersecurity update, issue 3 - October, 2014

  • Jones Day
  • -
  • Australia, Brazil, Canada, Chile, China, European Union, France, Germany, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Russia, Taiwan, USA
  • -
  • October 15 2014

On August 1, the Federal Trade Commission ("FTC") issued a report on mobile shopping applications. In it, the FTC found that such apps often fail to

Pharmaceutical & medical device regulatory update, issue 16

  • Jones Day
  • -
  • USA
  • -
  • October 10 2014

FDA recently released two draft guidance documents laying out FDA's proposed framework for regulating Laboratory Developed Tests ("LDTs") as medical

FDA releases framework for overseeing Laboratory Developed Tests

  • Jones Day
  • -
  • USA
  • -
  • October 7 2014

On September 30, 2014, the U.S. Food and Drug Administration ("FDA") released the two draft guidance documents setting forth FDA's proposed framework

IRS issues guidance regarding the deductibility of litigation fees incurred by branded pharmaceutical companies when defending their patents against challenges to market exclusivity by generic companies

  • Jones Day
  • -
  • USA
  • -
  • October 2 2014

There is welcome clarity for branded pharmaceutical companies seeking to deduct legal fees incurred in defending their patents against challenges to

Pharmaceutical & medical device regulatory update, issue 15

  • Jones Day
  • -
  • USA
  • -
  • September 26 2014

Last week, President Obama signed an Executive Order and issued a national strategy to spur action within the federal government to address the

Pharmaceutical & medical device regulatory update, issue 14

  • Jones Day
  • -
  • USA
  • -
  • September 11 2014

On September 9, 2014, FDA released the first edition of the "Purple Book,"which is the analogue to the Orange Book for biologics. The Orange Book has

Pharmaceutical & medical device regulatory update, issue 13

  • Jones Day
  • -
  • USA
  • -
  • August 28 2014

Hydrocodone with acetaminophen has been the most widely prescribed drug since 2007, with more than 135 million prescriptions written in 2012. Due to

Pharmaceutical & medical device regulatory update, issue 12

  • Jones Day
  • -
  • USA
  • -
  • August 14 2014

On August 4, 2014, FDA issued a draft guidance titled Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

Food, dietary supplement & cosmetics regulatory update, Issue 11

  • Jones Day
  • -
  • Canada, China, USA
  • -
  • August 8 2014

Last week, a divided federal appeals court ruled that FDA cannot be forced to ban antibiotics in food-producing healthy livestock. Thedecision comes

FDA issues draft guidance on determination of reference product exclusivity for biologics

  • Jones Day
  • -
  • USA
  • -
  • August 7 2014

On August 4, the U.S. Food & Drug Administration ("FDA") issued a draft guidance titled "Reference Product Exclusivity for Biological Products Filed