The Tufts Center for the Study of Drug Development has collected data on th
e clinical and approval phases of the 26 new biopharmaceuticals approved by
the US Food and Drug Administration between 1980 and 1999, Here, the data
for biopharmaceuticals approved between 1995 and 1999 are presented grouped
by product category, review status, orphan-drug designation and therapeuti
c indication, and the mean phase lengths are compared. They are also compar
ed with the data for approvals during the periods 1982-1989, 1990-1994 and
1996-1998.