2017 Is Banner Year for Drug Approvals by the Food and Drug Administration

Alex M Ebied; Rhonda M Cooper-DeHoff

doi:10.1016/j.amjmed.2018.02.034

2017 Is Banner Year for Drug Approvals by the Food and Drug Administration

Am J Med. 2018 Sep;131(9):1025-1033. doi: 10.1016/j.amjmed.2018.02.034. Epub 2018 Apr 4.

Authors

Alex M Ebied¹, Rhonda M Cooper-DeHoff²

Affiliations

¹ Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, Fla. Electronic address: ebiedrx55@ufl.edu.
² Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, Fla.

PMID: 29626430
DOI: 10.1016/j.amjmed.2018.02.034

Abstract

In 2017, the US Food and Drug Administration approved 46 novel drugs, and 29 drugs received newly approved indications. This record setting year was due in part to the new expedited review pathways. A review of these drugs is summarized.

Keywords: Accelerated approval; FDA; Fast track; New indication; Novel drugs; Priority review.

Publication types

Review

MeSH terms

Drug Approval / statistics & numerical data*
Humans
United States
United States Food and Drug Administration*