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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).


Scott E. Foster
  • Gowling WLG

John Norman PhD
  • Gowling WLG


Gordon Harris
  • Gowling WLG