PDUFA Countdown

Backsliding is apparent

By some measures, PDUFA and PDUFA-II have been tremendously successful in reducing overall development times for drugs and biologics. But over the last year there has been erosion in the gains, according to FDA data and analyses by academic researchers.

On the positive side, the total clinical development time for a drug or biologic has decreased 22% from 1992 to 2001, according to the Tufts Center for the Study of Drug Development. During the same period, approval times decreased 92% and there was a 33% increase in the number of applications approved.