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U.S. Department of Health and Human Services

About FDA

Number of marketing applications received in the quarter (1)

Dictionary: These measures show marketing applications received during the quarter as well as various actions taken during the quarter. Marketing Applications (BLA, NDA, PMA, ANDA, BBPA, and Premarket Notifications (510(k)) are applications to request permission to market a product in the U.S. for a specific use.

Information is current as of September 30, 2014

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A26
January – March 2013N/A29
April – June 2013N/A16
July – September 2013N/A23

FY 2013 Total: 94

Footnotes

  • (1) Beginning in October 2012, these measures will be reported quarterly.

Number of overdue marketing applications at the end of the quarter (1)

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A0
January – March 2013N/A0
April – June 2013N/A0
July – September 2013N/A0

FY 2013 Total: 0

Footnotes

  • (1) Beginning in October 2012, these measures will be reported quarterly.

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 - 2013

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TimeTargetNumber
October – December 2012N/A55
January – March 2013N/A31
April – June 2013N/A61
July – September 2013N/A57

FY 2013 Total: 204

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 - 2013
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TimeTargetNumber
October – December 2012N/A55
January – March 2013N/A31
April – June 2013N/A61
July – September 2013N/A53

FY 2013 Total: 200

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 - 2013
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TimeTargetNumber
October – December 2012N/A0
January – March 2013N/A0
April – June 2013N/A0
July – September 2013N/A4

FY 2013 Total: 4

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.