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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 January 31, 2014

Fiscal Year - 2014

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TimeTargetNumber
October – December 2013N/A19
January – March 2014N/ATBD
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 19

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 - 2014
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TimeTargetNumber
October – December 2013N/A0
January – March 2014N/ATBD
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 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 - 2014

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TimeTargetNumber
October – December 2013N/A35
January – March 2014N/ATBD
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 35

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 - 2014
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TimeTargetNumber
October – December 2013N/A35
January – March 2014N/ATBD
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 35

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 - 2014
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TimeTargetNumber
October – December 2013N/A0
January – March 2014N/ATBD
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 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.