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U.S. Department of Health and Human Services

About FDA

Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing

Description: Factor XIa content in plasma-derived immunoglobulin products has recently been shown by FDA scientists to be related to an increased risk of thromogenicity in product recipients. FDA scientists will collaborate with the WHO Expert Committee on Biological Standardization (ECBS) to develop and characterize the 1st International Reference Reagent for Factor XIa, and, to conduct thrombogenicity assay harmonization studies with the European Medicines Agency (EMA) and National Institute for Biological Standards and Control (NIBSC).

FY 2013 Updates

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

Reviewing final report on the collaborative study on the 1st international reference reagent for activated Factor XI; discussing the plans for the FXIa multi-assay performance study.

Quarter 1

Completed Quarter 1

Waiting for National Institute for Biological Standards and Control (NIBSC) study protocol to review.

Quarter 2

Completed Quarter 2

Waiting for NIBSC study protocol to review.

Quarter 3

Completed Quarter 3

Reviewed the “Final report on the evaluation of the WHO Reference Reagent (RR) for Activated Blood Coagulation Factor XI (FXIa), Human” from the NIBSC which was presented to the Expert Committee on Biological Standardization (ECBS) in Geneva, October 21-25, 2013. Reviewed ECBS 2013 document, “Proposal for the 1st WHO International Standard (IS) for Activated Coagulation Factor XI (FXIa)” also from the NIBSC. This will replace the Reference Reagent discussed above. OBRR decided to support the establishment of this new WHO standard. A principal NIBSC scientist on the 1st IS FXIa standard study, Dr. Elaine Gray, will be visiting OBRR on November 6, 2013 to specifically discuss the design of the study.

Quarter 4

Completed Quarter 4

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

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.