In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially offering significant drug development and marketing advantages. Nonclinical testing programs for 505(b)(2) submissions are often reduced and, in some cases, are not even required. This paper provides an overview of the 505(b)(2) regulatory pathway with a focus on how nonclinical programs can be streamlined and accelerated.

在美国，FDA通过三种主要监管途径批准了药物：（i）505（b）（1）新药申请（NDA）；（ii）505（b）（2）保密协议；（iii）505（j）缩写为NDA（ANDA）。适当的途径取决于活性成分，已获批准的药品，药物制剂，临床适应症，接触途径以及其他因素。505（b）（2）NDA途径是一种监管批准途径，允许发起人使用现有的公共数据来代替进行研究；因此，有可能提供重大的药物开发和营销优势。505（b）（2）提交的非临床测试程序通常会减少，在某些情况下甚至不需要。本文概述了505（b）（2）调节途径，重点关注如何简化和加速非临床程序。