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Results: 1-10 of 198

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

Food, dietary supplement & cosmetics regulatory update, issue 16

  • Jones Day
  • -
  • USA
  • -
  • October 15 2014

FDA recently released a report showing the amount of antibiotics sold for use in livestock increased by 16 percent from 2009 to 2012. The report

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FDA recently released two draft guidance documents laying out FDA's proposed framework for regulating Laboratory Developed Tests ("LDTs") as medical

OIG seeks comment on recently published proposed rule expanding anti-kickback safe harbors

  • Jones Day
  • -
  • USA
  • -
  • October 9 2014

The federal Anti-Kickback Statute ("AKS") criminalizes the solicitation or payment of remuneration in order to induce business that is reimbursable

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On September 30, 2014, the U.S. Food and Drug Administration ("FDA") released the two draft guidance documents setting forth FDA's proposed framework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