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Number of efficacy supplements received in the month

Dictionary: Efficacy Supplements to NDAs and BLAs are applications to make a change (e.g., add a new indication) to an approved marketing application. These supplements have legislatively mandated timelines for review.

These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

• FY 2010
• FY 2011
• FY 2012
• All

Total number of actions taken on efficacy supplements during the month

Number of actions taken on efficacy supplements in the month that were within goal dates

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	16
Nov 2010	N/A	4
Dec 2010	N/A	8
Jan 2011	N/A	18
Feb 2011	N/A	11
Mar 2011	N/A	8
Apr 2011	N/A	11
May 2011	N/A	5
Jun 2011	N/A	2
Jul 2011	N/A	24
Aug 2011	N/A	8
Sep 2011	N/A	7

FY 2011 Total: 122

Number of actions taken on efficacy supplements in the month that were past goal dates

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	3
Nov 2010	N/A	1
Dec 2010	N/A	1
Jan 2011	N/A	1
Feb 2011	N/A	1
Mar 2011	N/A	1
Apr 2011	N/A	0
May 2011	N/A	1
Jun 2011	N/A	0
Jul 2011	N/A	0
Aug 2011	N/A	1
Sep 2011	N/A	0

FY 2011 Total: 10

For those actions taken past goal deadlines, median number of days past the goal date

Number of overdue efficacy supplements at the end of the month