Journal
AMERICAN JOURNAL OF MEDICINE
Volume 134, Issue 9, Pages 1096-1100Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.amjmed.2021.03.034
Keywords
Accelerated approval; Fast track; Novel drugs; Priority review; US Food and Drug Administration
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In 2020, the US Food and Drug Administration approved 53 novel drugs, with the majority being reviewed and approved through an expedited review pathway, and over half being approved for the treatment of rare diseases.
In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020. (C) 2021 Elsevier Inc. All rights reserved.
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