| Literature DB >> 30853471 |
Alex M Ebied1, Juri Na1, Rhonda M Cooper-DeHoff2.
Abstract
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.Keywords: Accelerated approval; FDA; Fast track; Novel drugs; Priority review
Mesh：
Year: 2019 PMID： 30853471 DOI： 10.1016/j.amjmed.2019.02.024
Source DB: PubMed Journal: Am J Med ISSN： 0002-9343 Impact factor: 4.965