title: The new drug approvals of 1987, 1988, and 1989: trends in drug development.
abstract: The new drug approvals of 1987, 1988, and 1989 were analyzed to determine whether there are any emerging trends in the US drug development and review processes. Sixty-four new drugs were approved by the FDA during this period, of which 55 met the Center for the Study of Drug Development's definition of a new chemical entity (NEC). For the 55 NCEs, the mean length of the investigational new drug application (IND) phase (IND filing to NDA submission) was 5.2 years, the new drug application (NDA) phase (NDA submission to approval) was 2.9 years, and the total phase (IND filing to NDA approval) was 8.1 years. Nine of the 55 NCEs were classified by the FDA as 1A (important therapeutic gain), 15 were classified as 1B (modest gain), 29 were classified as 1C (little or no gain), and 2 were classified as 1AA (drugs to treat AIDS and AIDS-related conditions); 10 drugs were granted orphan status. The mean NDA phase for 1A drugs was 2.4 years; 1B drugs, 2.9 years; 1C drugs, 3.1 years; 1AA drugs, 1.4 years; and orphan drugs, 2.5 years. Forty-four of the 55 NCEs (80%) were available in foreign markets before US approval was given, with a mean of 6.5 years of prior marketing. These data are consistent with figures for previous years and suggest little change in the rate of new drug development and review in the United States.
authors.affiliation: Study of Drug Development, Tufts University, Boston, Massachusetts 02111.
authors.forename: K I
authors.initials: KI
authors.lastname: Kaitin
authors.forename: P A
authors.initials: PA
authors.lastname: DiCerbo
authors.forename: L
authors.initials: L
authors.lastname: Lasagna
mesh_terms: D015507:Drugs, Investigational / Q000737:chemistry / Q000145:classification; D006801:Humans; D013678:Technology, Pharmaceutical / Q000639:trends*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational