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

Hwang, Thomas J; Darrow, Jonathan J; Kesselheim, Aaron S · JAMA · 2017

retrospective_cohort · Level III

Where this comes from

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.

Medical subject headings