Monday, December 10, 2001
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.