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Results:1-10 of 19

Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come


3D-printed food when will the laws take shape?
  • Gowling WLG
  • USA, Canada
  • September 12 2016

3D printing is the new buzz technology being used to replicate human tissues, fighter jet parts, and human prosthetics. The technology is also


Cybersecurity and medical devices: Electronic medical data increases product liability risk for medical device manufacturers
  • Gowling WLG
  • USA, Canada
  • May 3 2016

The value of stolen personal health information is ten to twenty times greater than a stolen credit card number.1 As the health-care industry


Coming soon to Canadian medical device manufacturers? "Failure to train" cases south of the border
  • Gowling WLG
  • USA, Canada
  • October 21 2014

Medical device manufacturers (“MDMs”) often have to defend against novel theories of liability put forward by plaintiff counsel. The most recent


U.S. FDA contemplates new rules for internet-delivered health information
  • Gowling WLG
  • USA
  • December 3 2009

In recognition of the increasing use of the Internet by consumers for health-related information, the FDA is seeking to determine whether it needs to regulate the promotion of drugs and medical devices on the Internet.


FDA approves guidelines to inform doctors of "off-label uses" for medicine and medical devices
  • Gowling WLG
  • USA
  • January 19 2009

The United States Food and Drug Administration (FDA) recently finalized guidelines which will allow pharmaceutical companies to inform doctors about unapproved uses of medicines and medical devices.


FDA clinical trial regulations - "Sentinal System"
  • Gowling WLG
  • USA
  • May 29 2008

On Thursday May 22, 2008, U.S. health officials announced that the FDA will implement a proactive system designed to help identify dangers associated with prescription drugs and medical devices that are currently on the market.


FDA seeks re-authorization of the Prescription Drug Fee User Act with higher fees
  • Gowling WLG
  • USA
  • June 21 2007

On June 12, 2007, the Deputy Commissioner for Policy of the FDA appeared before the House of Representatives (Subcommittee on Health) to discuss the reauthorization of the prescription drug user and medical device user fee programs.


Belinda A. Bain
  • Gowling WLG

Josh Hanet
  • Gowling WLG