title: The new drug approvals of 1990, 1991, and 1992: trends in drug development.
abstract: Efforts to speed the development and review of new drugs have increased sharply in recent years. This report, which is the third in a series on trends in drug development, examines the new drug approvals of 1990, 1991, and 1992. During the 3-year study period, the Food and Drug Administration (FDA) approved 79 new drugs, 74 of which met the Center for the Study of Drug Development's definition of a new chemical entity (NCE). Of the 74 NCEs, 36 (49%) were considered by the FDA to represent notable therapeutic gains and were selected for "priority" review (i.e., drugs rated 1P, 1A, 1AA, and 1B), and 38 (51%) were considered to represent little or no gain and received "standard" reviews (i.e., drugs rated 1S and 1C). Investigational new drug application (IND) filing and new drug application (NDA) submission dates on all 74 drugs were obtained from responses to our manufacturer surveys as well as from FDA and public sources. The mean length of the clinical phase (IND filing to NDA submission) was 6.1 years and that of the review phase (NDA submission to approval) was 2.6 years. Of the 74 NCEs, 43 (58%) were available in foreign markets at least 1 year before U.S. approval, with a mean of 5.6 years of foreign marketing. In general, 1990 to 1992 figures are similar to those in the last half of the 1980s.
authors.affiliation: Center for the Study of Drug Development, Tufts University, Boston, Massachusetts 02111.
authors.forename: K I
authors.initials: KI
authors.lastname: Kaitin
authors.forename: M
authors.initials: M
authors.lastname: Manocchia
authors.forename: M
authors.initials: M
authors.lastname: Seibring
authors.forename: L
authors.initials: L
authors.lastname: Lasagna
mesh_terms: D017277:Drug Approval / Q000191:economics / Q000706:statistics & numerical data*; D015507:Drugs, Investigational; D006801:Humans; D017387:Investigational New Drug Application / Q000706:statistics & numerical data; D009965:Orphan Drug Production / Q000706:statistics & numerical data; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational