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Droice Labs showcases SuperLineage in session with FDA
On February 2, 2024, Droice Labs participated in a listening session with the Food and Drug Administration (FDA) Real World Evidence Subcommittee to discuss SuperLineageTM. This innovation from Droice provides a standardized format for item-level data traceability, essential to the reliability of real-world patient data (RWD) for regulatory decision-making.
The potential of RWD to improve disease understanding and clinical trials is significant, but quality and reliability challenges limit its use. During the session, Droice highlighted the challenges encountered in using RWD for regulatory applications and presented SuperLineage as a solution providing traceability and reliability, criteria highlighted by FDA officials as essential.
Droice Labs CEO Mayur Saxena expressed optimism about the future of RWD in patient care, supported by the discussion with the FDA. The session featured representatives from the FDA, affirming the commitment to effective use of RWD.
R. P.
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