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U.S. Department of Health and Human Services

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Percentage of lot distribution reports received by the Office of Biostatistics and Epidemiology (OBE) in the quarter that were entered into RMS-BLA within 7 days

Dictionary: This measure tracks the number of lot distribution reports received by CBER in the month and uploaded into CBER’s Regulatory Management System – Biologics License Applications database (RMS-BLA) within 7 days. Manufacturers of vaccines and other biological products will electronically submit post-marketing lot distribution data to CBER’s Lot Distribution Database (LDD) for use in post-marketing safety surveillance. Previously, this data was primarily submitted to CBER as paper reports. The conversion to electronic submissions will provide a standardized and consistent presentation of lot distribution information which will improve the accuracy, efficiency and timeliness.

Information is current as of March 31, 2014

Fiscal Year - 2013

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TimeTargetPercent
October – December 2012N/AN/A
January – March 2013N/A51
April – June 2013N/A84
July – September 2013N/A71

FY 2013 Total: 69%

Number of lot distribution reports received by OBE in the quarter and uploaded to RMS-BLA within 7 days

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/AN/A
January – March 2013N/A30
April – June 2013N/A49
July – September 2013N/A48

FY 2013 Total: 127

Number of lot distribution reports received by OBE in the quarter

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/AN/A
January – March 2013N/A59
April – June 2013N/A58
July – September 2013N/A68

FY 2013 Total: 185

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.