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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.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

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)

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)

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.