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经13年的试行后,美国食品与药物管理局(FDA)终于实施了新的针对调查过的新药申请和审批的觇定。这一新规定于1987年6月17日起生效,但 FDA 将在1988年之前同时接受符合新或旧两种规定的申请。新规定的申请表格将大为简化,表中要填写调查计划的简短摘要、原始记录以及与该药物有关的支持性技术资料。对第一阶段的研究,FDA 缩小了审查的范围,将重点放在人体安全试验上。此外,临床调查人员将被允许根据其试验过程中得到的结果(虽未预先报告 FDA)而修改其原始记
After 13 years of trial, the US Food and Drug Administration finally implemented new regulations on the application for and approval of new drugs under investigation. The new rule came into force on June 17, 1987, but the FDA will accept both new and old regulations by 1988. The new application form will be greatly simplified. A short summary of the survey plan, the original records and supporting technical material related to the drug will be filled in. For the first phase of the study, the FDA narrowed the scope of the review by focusing on human safety trials. In addition, clinical investigators will be allowed to modify their original records based on the results obtained during the course of their trials, although not previously reported to the FDA