Key measurements of U.S. CDER drug approvals in 2019

This statistic depicts the percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2019 that met select key measures. According to the data, 100 percent of all drugs approved in 2019 by CDER met the PDUFA goal date for approval and 44 percent of approved drugs were drugs for orphan diseases.

Percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2019 that met select key measurements

Percentage of drugs approved in 2019
Met PDUFA goal date*100%
First cycle of review90%
Approved in the United States before receiving approval in any other country69%
Priority review58%
Drugs for orphan diseases44%
First-in-class42%
Fast Track35%
Breakthrough therapy27%
Accelerated Approval program19%
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Source

Release date

January 2020

Region

United States

Survey time period

2019

Supplementary notes

CDER is a regulatory agency and part of the U.S. food and Drug Administration.

* Prescription Drug User Fee Act (PDUFA)

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