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

Abstract

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 mean length of the clinical phase (investigational new drug application [IND] filing to new drug application [NDA] submission) was 70.3 months (ie, 5.9 years), and the approval phase (NDA submission to approval) was 16.8 months (1.4 years). Both the clinical and approval phases represent decreases from those values for the previous three-year period (19% and 31%, respectively). The decrease in the clinical phase for the 1996 to 1998 NCEs represents the first such decline since the mid-1980s. The mean approval phase for priority NCEs (11.8 months) was 38% shorter than that for standard NCEs (19.5 months). Of the 107 NCEs for which foreign marketing data were available, 49% were first approved for marketing in the United States, while 26% were available in foreign markets one or more years prior to United States approval, with a mean of 5.7 years of prior foreign marketing. The percent of products first available in the United States represents a considerable increase over that number for previous years.

Keywords

New chemical entity Drug development Pharmaceutical innovation Pharmaceutical industry Food and Drug Administration Prescription Drug User Fee Act of 1992 FDA Modernization Act of 1997

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