2018 年新药批准——又创历史新高！
New Drug Approvals in 2018 - Another Record Year!
机构信息
Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, Fla.
Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, Fla.
出版信息
Am J Med. 2019 Sep;132(9):1038-1043. doi: 10.1016/j.amjmed.2019.02.024. Epub 2019 Mar 7.
In 2018, the US Food and Drug Administration approved 59 novel drugs. This all-time record was due primarily to the expedited review pathways; 43 of the 59 (73%) novel drug approvals were designated in an expedited review pathway, and 34 of the 59 (58%) were approved for treatment of rare diseases. A review of these novel drugs is summarized.
2018 年，美国食品和药物管理局批准了 59 种新的药物。这一创纪录的数字主要得益于加速审查途径；59 种新批准药物中的 43 种（73%）被指定为加速审查途径，其中 34 种（58%）用于治疗罕见疾病。本文对这些新药进行了综述。
Zotero 插件