Posted by bogluem on August 9, 2005, at 12:38:44
On June 16, 2005 the FDA indicated it had accepted Somerset's May 26, 2005 response as complete and issued a Prescription Drug User Fee Act (PDUFA) "goal date" of November 27, 2005. Does anyone know what that November 27, 2005 goal date means? Does it mean it is likely that the FDA's final approval will be by that date. I read somewhere that the FDA met the PDUFA goal date in over 90+% cases.
poster:bogluem
thread:539605
URL: http://www.dr-bob.org/babble/20050803/msgs/539605.html