新药申请人与美国食品和药物管理局的非公开性会议

Close meeting with U. S. Food and Drug Administration for new drug development

对于一个新药,美国食品和药物管理局(FDA)从其临床试验的开始就着手了药物研发的监管。申请人可以要求与FDA会面来征求建议,使药物的研发符合相关法律法规。根据2008年的一份权威研究显示,新药申请人要求此类会议的次数越多,新药在第一轮审批后就获得批准的几率也越大。本文主要介绍了FDA与药物申请人的非公开性会议。

When a new drug goes into clinical trials stage, the U. S. Food and Drug Administration （FDA） starts its oversight. Sponsor is able to request meeting with FDA for comments in order to comply with related regulations. According to an authoritative survey, the more meeting with FDA is requested by sponsor, the higher rate of first-round approval achieves. This article introduces the close meetings between FDA and sponsor.