Wednesday, March 26, 2008
Today's Wall Street Journal includes an interesting article by Jeanne Whalen comparing the FDA's approval process for new drug applications with the European process:
It is unclear whether getting FDA approval has become tougher than getting approval from its European Union counterpart in London, the European Medicines Agency, known as the EMEA. Current data on the speed of approvals in the regions aren't available. In a study comparing the FDA and EMEA from 2000 to 2005, Tufts University researchers found that mean approval times were similar at the agencies -- about 15.7 months -- but that there was "considerably more variability" in FDA approval times.
Some industry executives theorize that the FDA faces more public and political pressure when considering approvals.