An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms.

FDA在2016年批准的药物概述显示，长期趋势发生了戏剧性的破坏。新分子实体（NME）的数量下降，反映出近五十年来观察到的小分子批准率最低。此外，行业整合的步伐大大放缓。并购的影响使具有过往审批经验和持续研发活动的组织总数减少到102个，在较成熟的制药公司和较新的生物技术公司之间平均分配。尽管存在这些实质性差异，但该行业仍在继续寻求监管激励措施，证据是使用孤儿或优先级名称批准的NME比例持续增加，并且2016年批准的几乎所有肿瘤药物均采用了这些机制。