期刊
AMERICAN JOURNAL OF MEDICINE
卷 136, 期 6, 页码 545-550出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.amjmed.2023.02.019
关键词
Accelerated approval; Fast track; FDA; Novel drugs; Priority review
In 2022, the FDA approved 37 novel drugs, with 24 (65%) of them being reviewed and approved through an expedited pathway and 20 (54%) approved for rare disease treatment. This article provides a summary of the novel drugs approved by the FDA in 2022.
In 2022, the US Food and Drug Administration (FDA) approved 37 novel drugs. Twenty-four of the 37 (65%) novel drug approvals were reviewed and approved through an expedited review pathway and 20 of the 37 (54%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2022.(c) 2023 Elsevier Inc. All rights reserved. center dot The American Journal of Medicine (2023) 136:545-550
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