Key measurements of U.S. CDER drug approvals in 2018
Percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2018 that met select key measurements
This statistic depicts the percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2018 that met select key measures. According to the data, 100 percent of all drugs approved in 2018 by CDER met the PDUFA goal date for approval and 58 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 2018 that met select key measurements
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| Percentage of drugs approved in 2018 | |
|---|---|
| Met PDUFA goal date* | 100% |
| First cycle of review | 95% |
| Priority review | 73% |
| Approved in the United States before receiving approval in any other country | 71% |
| Drugs for orphan diseases | 58% |
| Fast Track | 41% |
| First-in-class | 32% |
| Breakthrough therapy | 24% |
| Accelerated Approval program | 7% |
Source
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