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

About FDA

Number of actions taken on marketing applications during the quarter (1) (2)

Dictionary: This measure shows marketing applications receipts and various actions taken in month. It provides a workload perspective. Marketing Applications (BLA, NDA, PMA, and Premarket Notifications (510(k)) are applications to request permission to market a product in the U.S. for a specific use. This measure tracks CBER’s performance in issuing decisions within established timeframes.

Fiscal Year - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A9
Nov 2011N/A9
Dec 2011N/A12
Jan 2012N/A8
Feb 2012N/A11
Mar 2012N/A13
Apr 2012N/A12
May 2012N/A12
Jun 2012N/A12
Jul 2012N/A11
Aug 2012N/A15
Sep 2012N/A8

FY 2012 Total: 132

Footnotes

  • (1) Beginning in October 2012, this measure will be tracked quarterly
  • (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs.

Number of actions taken on marketing applications in the quarter that were within goal dates (1) (2)

Fiscal Year - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A9
Nov 2011N/A9
Dec 2011N/A12
Jan 2012N/A8
Feb 2012N/A11
Mar 2012N/A13
Apr 2012N/A12
May 2012N/A12
Jun 2012N/A12
Jul 2012N/A11
Aug 2012N/A15
Sep 2012N/A8

FY 2012 Total: 132

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly
  • (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs.

Number of actions taken on marketing applications in the month that were past goal dates (2)

Fiscal Year - 2012

Skip graphic and jump to text data

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

FY 2012 Total: 0

Footnotes

  • (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs.

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.