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

Thomas J Hwang; Jonathan J Darrow; Aaron S Kesselheim

doi:10.1001/jama.2017.14896

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

JAMA. 2017 Dec 5;318(21):2137-2138. doi: 10.1001/jama.2017.14896.

Authors

Thomas J Hwang¹, Jonathan J Darrow¹, Aaron S Kesselheim¹

Affiliation

¹ Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

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