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Results:1-10 of 22

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


U.S. patients receive greater access to unapproved medications
  • Gowling WLG
  • USA
  • August 21 2009

Seriously ill patients will have greater and easier access to unapproved medicines due to new USFDA regulations.


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 clinical trial regulations - institutional review boards
  • Gowling WLG
  • USA
  • May 29 2008

As part of the FDA's and the HHS Office for Human Research Protections' initiative of issuing regulations instead of guidances for clinical trials, they are working on a final rule for registering institutional review boards (IRBs).


PMPRB asserts jurisdiction over US-based sales
  • Gowling WLG
  • USA, Canada
  • February 7 2008

In a recent decision, the Patented Medicine Prices Review Board (PMPRB) has ruled that it has jurisdiction over products sold in the U.S., but imported into Canada under Health Canada's Special Access Program (SAP).


PDUFA reauthorization package clears first hurdle
  • Gowling WLG
  • USA
  • October 4 2007

The United States' House of Representative recently passed the authorization of the Prescription Drug User Fee Act (PDUFA).


FDA announces new advisory committee for risk communication
  • Gowling WLG
  • USA
  • June 21 2007

On June 4, 2007, the FDA announced the formation of a new committee to advise on how to improve communication of the risks and benefits of FDA approved products to the public.



Scott E. Foster
  • Gowling WLG