The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era

This is the fifth in a series of triennial reports by the Tufts Center for the Study of Drug Development (CSDD) examining various aspects of recent new drug approvals in the United States. In 1996, 1997, and 1998 the United States Food and Drug Administration (FDA) approved 122 new drugs, 110 of which met Tufts CSDD’s definition of a new chemical entity (NCE). Of the 110, 38 (35%) received priority review, while 72 (65%) had standard review. The...