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Faster review offset by longer drug development
  • Gowling WLG
  • USA
  • January 19 2009

According to the report Outlook 2009 released by the Tufts Center for the Study of Drug Development, gains made by the U.S. FDA in the speed of review of new drugs (average review time declined by 1.1 years in time 2005-2007 period) have been largely offset by longer clinical development times due to the complexity of the diseases being studied.


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).


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.


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.


New Drug Safety Bill in the US
  • Gowling WLG
  • USA
  • October 4 2007

President Bush signed a Drug Safety Bill giving the FDA more money and new powers to police potentially serious side effects of marketed prescription drugs.


Isabel Raasch
  • Gowling WLG

Scott E. Foster
  • Gowling WLG


John Norman PhD
  • Gowling WLG

Wendy J. Wagner
  • Gowling WLG