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Mossinghoff先生1990年1月17日在华盛顿宣布:1989年FDA批准23个新分子实体(NME_s),这23个新药平均批准时间为32.5月,略长于前年(1988年31.3月),每个新药平均至少需要10年时间来进行开发和规则审查(其中包括至少1年的临床前开发和平均6.4年的人体试验)。1989年FDA还批准14个生物制品上市。这些药物的结构如下:
Mr. Mossinghoff announced in Washington on January 17, 1990: The FDA approved 23 new Molecular Entities (NMEs) in 1989. The average approval time for these 23 new drugs was 32.5 months, slightly longer than the previous year (March 31, 1988) with an average of each new drug It will take at least 10 years for development and regulatory review (including at least 1 year of preclinical development and an average of 6.4 years of human testing). The FDA also approved 14 biological products in the market in 1989. The structure of these drugs is as follows: