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U.S. Department of Health and Human Services

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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.

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A10
Nov 2010N/A5
Dec 2010N/A14
Jan 2011N/A7
Feb 2011N/A6
Mar 2011N/A11
Apr 2011N/A11
May 2011N/A5
Jun 2011N/A13
Jul 2011N/A12
Aug 2011N/A4
Sep 2011N/A7

FY 2011 Total: 105

Total number of actions taken on efficacy supplements during the month

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A19
Nov 2010N/A5
Dec 2010N/A9
Jan 2011N/A19
Feb 2011N/A12
Mar 2011N/A9
Apr 2011N/A11
May 2011N/A6
Jun 2011N/A2
Jul 2011N/A24
Aug 2011N/A9
Sep 2011N/A7

FY 2011 Total: 132

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A16
Nov 2010N/A4
Dec 2010N/A8
Jan 2011N/A18
Feb 2011N/A11
Mar 2011N/A8
Apr 2011N/A11
May 2011N/A5
Jun 2011N/A2
Jul 2011N/A24
Aug 2011N/A8
Sep 2011N/A7

FY 2011 Total: 122

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A1
Dec 2010N/A1
Jan 2011N/A1
Feb 2011N/A1
Mar 2011N/A1
Apr 2011N/A0
May 2011N/A1
Jun 2011N/A0
Jul 2011N/A0
Aug 2011N/A1
Sep 2011N/A0

FY 2011 Total: 10

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

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A99
Nov 2010N/A234
Dec 2010N/A4
Jan 2011N/A121
Feb 2011N/A609
Mar 2011N/A1
Apr 2011N/AN/A
May 2011N/A256
Jun 2011N/AN/A
Jul 2011N/AN/A
Aug 2011N/A122
Sep 2011N/AN/A

Number of overdue efficacy supplements at the end of the month

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A2
Dec 2010N/A2
Jan 2011N/A10
Feb 2011N/A10
Mar 2011N/A9
Apr 2011N/A5
May 2011N/A8
Jun 2011N/A9
Jul 2011N/A7
Aug 2011N/A6
Sep 2011N/A6

FY 2011 Total: 78

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.