The new drug approvals of 1990, 1991, and 1992: trends in drug development.
作者： Kenneth I. Kaitin , Michael Manocchia , Mark Seibring , Louis Lasagna
DOI: 10.1002/J.1552-4604.1994.TB03975.X
关键词:
摘要: Efforts to speed the development and review of new drugs have increased sharply in recent years. This report, which is third a series on trends drug development, examines approvals 1990, 1991, 1992. During 3-year study period, Food Drug Administration (FDA) approved 79 drugs, 74 met Center for Study Development's definition chemical entity (NCE). Of NCEs, 36 (49%) were considered by FDA represent notable therapeutic gains selected "priority" (i.e., rated 1P, 1A, 1AA, 1B), 38 (51%) little or no gain received "standard" reviews 1S 1C). Investigational application (IND) filing (NDA) submission dates all obtained from responses our manufacturer surveys as well public sources. The mean length clinical phase (IND NDA submission) was 6.1 years that (NDA approval) 2.6 43 (58%) available foreign markets at least 1 year before U.S. approval, with 5.6 marketing. In general, 1990 1992 figures are similar those last half 1980s.
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