• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Number of efficacy supplements received in the month

Measure was implemented starting January 2010

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 - 2010

Skip graphic and jump to text data

Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A2
Feb 2010N/A7
Mar 2010N/A14
Apr 2010N/A16
May 2010N/A4
Jun 2010N/A7
Jul 2010N/A9
Aug 2010N/A3
Sep 2010N/A17

Total number of actions taken on efficacy supplements during the month

Measure was implemented starting January 2010

Fiscal Year - 2010

Skip graphic and jump to text data

Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A7
Feb 2010N/A8
Mar 2010N/A11
Apr 2010N/A12
May 2010N/A9
Jun 2010N/A9
Jul 2010N/A8
Aug 2010N/A4
Sep 2010N/A6

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

Measure was implemented starting January 2010

Fiscal Year - 2010
Skip graphic and jump to text data.

Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A7
Feb 2010N/A8
Mar 2010N/A10
Apr 2010N/A12
May 2010N/A7
Jun 2010N/A9
Jul 2010N/A8
Aug 2010N/A2
Sep 2010N/A6

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

Measure was implemented starting January 2010

Fiscal Year - 2010
Skip graphic and jump to text data.

Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A0
Feb 2010N/A0
Mar 2010N/A1
Apr 2010N/A0
May 2010N/A2
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A2
Sep 2010N/A0

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

Measure was implemented starting January 2010

Fiscal Year - 2010

Skip graphic and jump to text data

Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/A18
Apr 2010N/AN/A
May 2010N/A7
Jun 2010N/AN/A
Jul 2010N/AN/A
Aug 2010N/A1,161
Sep 2010N/AN/A

Number of overdue efficacy supplements at the end of the month

Measure was implemented starting January 2010

Fiscal Year - 2010

Skip graphic and jump to text data

Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A3
Feb 2010N/A4
Mar 2010N/A3
Apr 2010N/A6
May 2010N/A4
Jun 2010N/A6
Jul 2010N/A6
Aug 2010N/A7
Sep 2010N/A7

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.