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Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia

Authors :
Jasmeet K. Kalsi
Michael C. Davis
Brian J. Miller
Thomas Birkner
Mitchell V. Mathis
Source :
New England Journal of Medicine. 376:2503-2506
Publication Year :
2017
Publisher :
Massachusetts Medical Society, 2017.

Abstract

In the case of valbenazine, which was recently approved for tardive dyskinesia, a small company pursued thoughtful, efficient trial design and an unusual application of remote assessment in clinical trials, and the FDA took an engaged and flexible approach to review.

Details

ISSN :
15334406 and 00284793
Volume :
376
Database :
OpenAIRE
Journal :
New England Journal of Medicine
Accession number :
edsair.doi.dedup.....3e26dee515f22eed521d7a0ecd3af4e3