Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects

Liao, Tsung-Jen; Crosby, Lynn; Cross, Kevin; Chen, Minjun; Elespuru, Rosalie

doi:10.1016/j.yrtph.2024.105591

Regulatory Toxicology and Pharmacology

2024

DOI: 10.1016/j.yrtph.2024.105591

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Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects

Tsung-Jen Liao,

Lynn Crosby,

Kevin Cross

et al.

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2024

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Cited by 2 publications

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Hollaender award 2023: Adventures in applied genetic toxicology

Elespuru

2024

Environ and Mol Mutagen

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This work describes career “adventures” into applied research in environmental mutagenesis. Surprising and interesting results, as well as publications in Nature and Science, may counter an assumption that applied research is not as exciting or impactful as basic research. The narrative is described in terms of “mentors,” whose advice had a lasting impact and resonated in many ways. Adventures included forays into nitrosamine mutagenicity, nanomaterial assessment, photoactivated DNA damaging agents, p53 gene mutagenicity, germ cell mutagenic risk, bacterial mutagenicity assays, genotoxicity of cell phone radiation, Covid diagnostic PCR assays, personalized cancer prevention, and >25 years in regulatory safety assessment at FDA. FDA work included review of genotoxicity data, experiments in the lab, international standards generation, and collaboration with others to foster better analyses of DNA damaging agents, generally in relation to cancer risk. As demonstrated by accidental adventures that led to scientific as well as life‐altering personal realizations, many of the most critical happenings in science and in life turn out to be “random,” unexpected, events. Finally, with this work and that of my lifelong tripmate William Lijinsky as models, it is suggested that a “non‐hypothesis driven,” open‐ended approach to research can be path‐breaking and forefront.

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Hollaender award 2023: Adventures in applied genetic toxicology

Elespuru

2024

Environ and Mol Mutagen

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Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database

Mishali,

Sheffer,

Mishali

et al. 2024

Clinical Therapeutics

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Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects

Cited by 2 publications

References 18 publications

Hollaender award 2023: Adventures in applied genetic toxicology

Hollaender award 2023: Adventures in applied genetic toxicology

Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database

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