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The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

Authors :
Aaron S. Kesselheim
Jonathan J. Darrow
Thomas J Hwang
Source :
JAMA. 318(21)
Publication Year :
2017

Abstract

This study uses the Drugs@FDA database to analyze clinical development times for drugs to treat serious diseases within the 4 FDA expedited programs intended to speed drug review and approval.

Details

ISSN :
15383598
Volume :
318
Issue :
21
Database :
OpenAIRE
Journal :
JAMA
Accession number :
edsair.doi.dedup.....2f922e6243ff4a9c86de1bc568f1e291