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A multi-dimensional comparative study of 505(b)(2) NDAs approved by FDA and Class 2 NDAs approved by NMPA from 2017 to 2023: Uncovering trends, characteristics, and regulation of modified new drugs

Author:

Lixia Fu,Songtao Dong,Ran Xie,Guoshu Jia,Nan Zhao,Qian Xiang,Xiwei Ji,Xia Zhao,Xiaoyuan Chen,Lingyue Ma,Yimin Cui

Publication:

Regulatory Toxicology and Pharmacology

Publisher:

Elsevier

Date:

November 2025

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