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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 June 30, 2014

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A261
January – March 2013N/A177
April – June 2013N/A164
July – September 2013N/A166

FY 2013 Total: 768

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

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

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 - 2013

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TimeTargetNumber
October – December 2012N/A299
January – March 2013N/A251
April – June 2013N/A180
July – September 2013N/A215

FY 2013 Total: 945

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

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A297
January – March 2013N/A251
April – June 2013N/A180
July – September 2013N/A213

FY 2013 Total: 941

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

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A2
January – March 2013N/A0
April – June 2013N/A0
July – September 2013N/A2

FY 2013 Total: 4

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.