U.S. Food and Drug Administration Center for Drug Evaluation and ResearchSkip navigation

CDER - Center for Drug Evaluation and Research Logo

Drug Information

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

CDER Guide to Median Approval Time Statistics

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

Author:

Center or Drug Evaluation and Research

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

 

totop.gif (1525 bytes) Back to Top  Back Back to Drug Information

FDA/Center for Drug Evaluation and Research
Last Updated: April 15, 2003
Originator: OC
HTML by MAU