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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: Manufacturers of vaccines and other biological products with approved Biologics License Applications (BLAs) are required to submit post-marketing lot distribution data to CBER’s Lot Distribution Database (LDD) at least every 6 months for use in post-marketing safety surveillance. This measure tracks the proportion of successfully transmitted lot distribution reports that were uploaded into CBER’s Regulatory Management System – Biologics License Applications database (RMS-BLA) within 7 days. Note that as of June 10, 2015, companies are required to submit Lot Distribution Data electronically in accordance with the 21 CFR 600.81. In order for a LDD submission to be successfully transmitted to FDA, it must pass automated, electronic quality control checks. Due to technical difficulties experienced by some companies as they transition to electronic reporting, some submissions have failed these quality control checks, requiring the company to revise and resubmit. While the companies are resolving their technical difficulties, the total number of LDD reports successfully transmitted and reflected in the FDA-Track report may temporarily be less than in prior quarters. As companies improve their internal processes, we expect the number of submissions that are successfully transmitted in a given quarter to stabilize and return to levels similar to those prior to the electronic reporting requirement.

Information is current as of September 30, 2021

Fiscal Year - 2021

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TimeTargetPercent
Oct - Dec 2020N/A91
Jan - Mar 2021N/A99
Apr - Jun 2021N/A88
Jul - Sept 2021N/A99

FY 2021 Total: 94%

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

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A41
Jan - Mar 2021N/A96
Apr - Jun 2021N/A43
Jul - Sept 2021N/A106

FY 2021 Total: 286

Number of lot distribution reports received by OBE in the quarter

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A45
Jan - Mar 2021N/A97
Apr - Jun 2021N/A49
Jul - Sept 2021N/A107

FY 2021 Total: 298

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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