Journal
AMERICAN JOURNAL OF MEDICINE
Volume 132, Issue 9, Pages 1038-1043Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.amjmed.2019.02.024
Keywords
Accelerated approval; Fast track; FDA; Novel drugs; Priority review
Categories
Ask authors/readers for more resources
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. (C) 2019 Elsevier Inc. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available
Share Paper
