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 - Lixia Fu; Songtao Dong; Ran Xie; Guoshu Jia; Nan Zhao; Qian Xiang; Xiwei Ji; Xia Zhao; Xiaoyuan Chen; Lingyue Ma; Yimin Cui (Regulatory Toxicology and Pharmacology, 2025)