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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 - 2014

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TimeTargetNumber
October – December 2013N/A180
January – March 2014N/A178
April – June 2014N/A194
July – September 2014N/ATBD

FY 2014 YTD: 552

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

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

FY 2014 YTD: 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 - 2014

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TimeTargetNumber
October – December 2013N/A208
January – March 2014N/A215
April – June 2014N/A221
July – September 2014N/ATBD

FY 2014 YTD: 644

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

Fiscal Year - 2014
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TimeTargetNumber
October – December 2013N/A204
January – March 2014N/A209
April – June 2014N/A220
July – September 2014N/ATBD

FY 2014 YTD: 633

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

Fiscal Year - 2014
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TimeTargetNumber
October – December 2013N/A4
January – March 2014N/A6
April – June 2014N/A1
July – September 2014N/ATBD

FY 2014 YTD: 11

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.