Abstract：
An analysis of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 69 new entities in the year 2023, 50 % more than in the previous year. Oncology drugs tied with congenital and infectious diseases drugs for the most approvals. Although orphan and priority approvals continued at a high pace, the rate of fast-track approvals continued to decline. The rate of industry consolidation also picked up again after decreasing slightly in 2022.
摘要：
对药物评估与研究中心（CDER）和生物制品评估与研究中心（CBER）批准的所有新实体的分析确定了68个{AuQ：这应该是69，如图1A和B所示？}2023年的新实体，比上一年增加50％。肿瘤药物与先天性和感染性疾病药物结合，获得最多批准。尽管孤儿和优先批准仍在继续，快速批准率继续下降。行业整合率在2022年略有下降后也再次回升。
