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U.S. Department of Health and Human Services

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Number of Biologics License Application (BLA) manufacturing supplements received in the quarter

Dictionary: These measures show marketing applications received during the quarter as well as various actions taken during the quarter. BLA manufacturing supplements are submissions that propose changes to a licensed products’ approved manufacturing process.

Information is current as of September 30, 2021

Fiscal Year - 2021

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TimeTargetNumber
Oct - Dec 2020N/A280
Jan - Mar 2021N/A266
Apr - Jun 2021N/A261
Jul - Sept 2021N/A247

FY 2021 Total: 1054

Number of overdue BLA manufacturing supplements at the end of the quarter

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A0
Jan - Mar 2021N/A0
Apr - Jun 2021N/A0
Jul - Sept 2021N/A0

FY 2021 Total: 0

Number of actions taken on BLA manufacturing supplements in the quarter that were within goal dates

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A263
Jan - Mar 2021N/A249
Apr - Jun 2021N/A280
Jul - Sept 2021N/A303

FY 2021 Total: 1095

Number of actions taken on BLA manufacturing supplements in the quarter that were past goal dates

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A1
Jan - Mar 2021N/A4
Apr - Jun 2021N/A5
Jul - Sept 2021N/A6

FY 2021 Total: 16

Number of actions taken on Biologics License Application (BLA) manufacturing supplements in the quarter

Dictionary: These measures show marketing applications received during the quarter as well as various actions taken during the quarter. BLA manufacturing supplements are submissions that propose changes to a licensed products’ approved manufacturing process.

Fiscal Year - 2021

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TimeTargetNumber
Oct - Dec 2020N/A264
Jan - Mar 2021N/A253
Apr - Jun 2021N/A285
Jul - Sept 2021N/A309

FY 2021 Total: 1111

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.

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