Neyarapally, George A. http://orcid.org/0009-0003-6975-787X
Wu, Leihong
Xu, Joshua
Zhou, Esther H.
Dang, Oanh
Lee, Joann
Mehta, Dharmang
Vaughn, Rochelle D.
Pinnow, Ellen
Fang, Hong
Article History
Accepted: 15 July 2024
First Online: 31 July 2024
Declarations
:
: No funding was received in relation to the preparation of this manuscript. This work was completed by FDA staff and a medical resident on rotation with FDA as part of their regular duties.
: The authors declare that they have no conflicts of interest.
: Not applicable, because this article does not contain any studies on human or animal subjects.
: Not applicable.
: Not applicable.
: For the validation study, the labeling data is publicly available at: <u>.</u>
: The source code of the LabelComp tool is available at .
: All authors contributed to the conception and design of the study. LW, JX, and HF developed the LabelComp tool. EHZ and EP assisted in the development of the tool. GAN, EHZ, OD, JHL, DM, EP, and RDV performed the validation study. All authors analyzed the data. GAN and LW wrote the first draft of the manuscript. All authors critically revised the manuscript and read and approved the final manuscript.
: The views presented in this article do not necessarily reflect those of the U.S. Food and Drug Administration. Any mention of commercial products is for clarification and is not intended as an endorsement.