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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 - 2012

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TimeTargetNumber
Oct 2011N/A16
Nov 2011N/A11
Dec 2011N/A21
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 48

Total number of actions taken on efficacy supplements during the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A9
Nov 2011N/A6
Dec 2011N/A7
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 22

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A9
Nov 2011N/A6
Dec 2011N/A6
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 21

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A1
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 1

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

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A121
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

Number of overdue efficacy supplements at the end of the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A9
Nov 2011N/A14
Dec 2011N/A12
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 35

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.