U.S. Food and Drug Administration Center for Drug Evaluation and Research
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January 31, 2003
Table of Contents
CDER Guide to Median Approval Time Statistics
Median Approval Time Statistics
Submission cohort
Outcome of Submission Cohort
What happens to NDAs Submitted in Year "0"?
Approval cohort
Makeup of Approval cohorts
Applications approved in Year "0"
Effect of submission trends on statistics
In times where the number of submissions is INCREASING, the older applications have less impact on the median approval time.
In times where the number of submissions is DECREASING, older applications may dominate the median approval times.
Review Time
Review Cycle
Total Approval Time
NDA Approval Cohort Examples
Priority NDAs Approved in CY 1998
Priority NDAs Approved in CY 2002
Download presentation source [PowerPoint format]
Related Charts:
NDA Approval Rates for NDAs Received FY 1987-1992 and Approved within 36 Months
NDA Approval Rates for NDAs Received FY 1993-2002 and Approved within 36 Months
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FDA/Center for Drug Evaluation and Research Last Updated: April 15, 2003 Originator: OC HTML by MAU