Digital Commons Network^™

A Primer Of Medical Device Regulation: How To Go From Reactive To Proactive To Better Protect Patient Safety, Sneha Dave, Rita F. Redberg

Utah Law Review

FDA oversight of medical devices has too often been reactive, following preventable disasters rather than based on a proactive commitment to patient safety. The history of the device framework, the expansion of expedited pathways, weak postmarket surveillance, broad preemption, and conflicted patient advocacy together create a perfect storm of a regulatory environment that tolerates uncertainty and externalizes costs onto patients. Reforms such as time‑limited breakthrough status, mandatory and enforceable postmarket studies, requirements for more robust safety and efficacy data, and strengthened reporting duty for clinicians would move device regulation closer to FDA’s statutory mandate to protect public health. It would …

Noncoding Rna Transcripts Based Molecular Phenotyping Of Masld And Mash Patients, Frida M. Delgadillo, Karla Perez, Barbara Yang, Subramanian Dhandayuthapani, Murali Yallapu, Subhash C. Chauhan, Enrique I. Ramos, Shrikanth S. Gadad

School of Medicine Publications

Background and aims: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a progressive hepatic metabolic disorder characterized by excessive fat accumulation in hepatocytes. MASLD can advance to metabolic dysfunction-associated steatohepatitis (MASH). These conditions often lead to hepatic fibrosis, cirrhosis and hepatocellular carcinoma (HCC) if not timely diagnosed and managed; thus, molecular phenotyping of MASLD and MASH conditions is highly desirable. The analyses were performed to identify distinct, differentially expressed genes, particularly noncoding ones, in MASLD and MASH patient samples, thereby expanding diagnostic and therapeutic options.

Methods: We extracted the data from a recent transcriptomic study by Govaere et al. on MASLD …

Fda Policymaking In The Trump Deregulation Era, Jordan Paradise J.D.

Utah Law Review

This Article endeavors to contribute to and continue the conversation about how the Trump deregulatory agenda is impacting a vital national public health agency, the FDA, and our national collective public health in ways that deviate from longstanding agency policy and practice. Various other FDA policy actions deserve concerted attention by legal scholars, including the agency’s recent moves in the direct-to-consumer marketing (DTC) drug space through targeted warning letters and publicity about reforming the “adequate provision” standards, food additives and generally recognized as safe (GRAS) listing processes and directives to industry, adjustments to the biosimilar interchangeability requirements through guidance document, …

Fda In 2050: Best- And Worst-Case Scenarios, Michael S. Sinha

Utah Law Review

In 2025, the Trump administration disrupted many critical aspects of the biomedical research infrastructure in the United States. The Food and Drug Administration (FDA) was not spared. Robert F. Kennedy, Jr., a known vaccine denier with no health care experience, was confirmed as Secretary of the U.S. Department of Health and Human Services (HHS) in February 2025, followed by the confirmation of Dr. Martin Makary as Commissioner of the FDA in April. Departures of long-time FDA scientists, coupled with appointments of key personnel, seemingly because of their public stances on COVID-19 mRNA vaccines, have resulted in a tumultuous year for …

Evaluating The Case Against Fda Independence, Patricia J. Zettler, Rachel E. Sachs

Utah Law Review

Many former FDA officials, both politically-appointed leaders and those from the career ranks, as well as numerous FDA scholars have advocated for increased FDA independence in varied forms, and for good reason. At the same time, there are advantages to FDA’s current structure, and there may be ways to insulate career scientific experts’ decisions from political influence and to address other problems by generating independence, without overhauling the agency’s design. Policymakers should consider all options, as particular independence features may, or may not, be the best way, to address concerns about FDA’s capacity to carry out its vital public health …

The Revival Of Honor Killing In Iranian Kurdistan: A Sociological Analysis Of Gender, Land, And Identity, Parviz Sobhani

Dignity: A Journal of Analysis of Exploitation and Violence

Honor is a foundational yet restrictive sociocultural construct in Kurdish society of western Iran. Transgressions of its boundaries, particularly by women, are historically met with violent sanction. Despite processes of modernization, honor killings have re-emerged as a conspicuous phenomenon in Iranian Kurdistan, suggesting an active revival rather than a passive residue of tradition. This study employed a qualitative, interpretive phenomenological approach. The data were collected through semi-structured interviews with 21 social scientists and researchers from January 2022 to February 2024 in Iranian Kurdistan.  A grounded theory framework guided the thematic analysis. Findings reveal a dual symbolic encoding of honor: it …

When Protection Becomes Predation: Militarized Masculinity And Sexual Violence In Northeastern Nigeria, Tosin Osasona

Dignity: A Journal of Analysis of Exploitation and Violence

The study investigates the structural and situational drivers of conflict-related sexual violence (CRSV) perpetrated by state security actors in the context of Nigeria’s counterinsurgency campaigns in Borno State. Drawing on militarized masculinity and strain and deprivation theories, and using a qualitative, interpretive research design, the study argues that CRSV is not an isolated or episodic form of deviance by individual soldiers and security personnel but is embedded in routine military–civilian interactions. Advancing an interactionist explanation of CRSV in Nigeria’s Islamist counterinsurgency operations, the study demonstrates that the likelihood of sexual violence increases through the interaction of gendered institutional norms, operational …

Sensation And Perception V3, Todd A. Kahan

Open Educational Resources

Sensation and Perception V3 is an introductory college textbook that explores how we detect and interpret sensory information from the world around us. Covering all five major senses—vision, audition, touch, taste, and smell—the book provides a comprehensive overview of the biological and psychological processes that underlie perception. While all sensory modalities are discussed, the primary emphasis is on vision, tracing the flow of visual information from the moment light strikes the retina through the complex mechanisms that allow us to perceive objects, color, motion, and depth.

The Influence Of Childhood Experiential History On U.S. Vice President Jd Vance’S Personality, Amelia Brower, Aubrey Immelman

Psychology Faculty Publications

This paper presents the results of a developmental causal analysis of the adult personality of U.S. vice president JD Vance, from the conceptual perspective of personologist Theodore Millon.

Psychodiagnostically relevant data relating to Vance’s personality were collected from biographical sources and media reports and synthesized into a personality profile using the Millon Inventory of Diagnostic Criteria (MIDC), which yields 34 normal and maladaptive personality classifications congruent with DSM-III-R, DSM-IV, and DSM-5-TR.

The findings of the personality assessment were previously reported in a separate paper. Vance’s primary personality patterns were found to be Dominant/controlling and Ambitious/confident, supplemented by …

A Delayed Siamr Prostate Cancer Model With Vertical Transmission And Treatment: Stability Analysis And Numerical Simulation, Hüseyi̇n Demir, İnci̇ Çi̇li̇ngi̇r Süngü, İbrahi̇m Keles

Turkish Journal of Mathematics

​In this paper, we propose and analyse a delayed-compartmental mathematical model of prostate cancer dynamics that incorporates vertical transmission and therapeutic intervention. The population is stratified into five compartments: susceptible (S), infected/virally activated (I), asymptomatic infectious under treatment (A), malignant untreated (M), and recovered (R). A discrete time delay τ > 0 is introduced in the force-of-infection term to model the age-dependent onset of susceptibility in middle-aged adult males. Vertical transmission of viral etiology at a rate qΛ ensures that a fraction of newborns enter the infected compartment directly, rendering the disease persistent regardless of the basic reproduction number R₀. We …

Hyers-Ulam And Hyers-Ulam Rassias Stability Of Caputo Fractional Hahn Difference Equations, Karima Mohamed Oraby, Alaa E. Hamza, Afrah Al-Bossly

Turkish Journal of Mathematics

​In this paper, we investigate Hyers–Ulam and Hyers–Ulam–Rassias stability for fractional linear Hahn difference equations of Caputo Type. To the best of our knowledge, this is the first work concerning Hyers–Ulam type stability in the framework of Caputo fractional Hahn difference equations, thereby filling a significant gap in the literature on fractional stability theory. Our approach is based on establishing an equivalence between the fractional Hahn difference initial value problem and a corresponding fractional integral equation, via the Caputo–Hahn inversion formula. These results lay a strong groundwork for analyzing the stability of Hahn fractional systems, which could be useful in …

A Note On The Periodic Orbits Of Wolbachia Spread Dynamics In Mosquito Populations In Periodic Environments, Jose S. Cánovas

Turkish Journal of Mathematics

We consider the periodic model introduced by B. Zheng and J. Yu, and disprove the conjectures on the number of periodic orbits the model can have. We rebuild the conjecture to prove that for periodic sequences of maps of any period, the number of nonzero periodic trajectories is bounded by two.

Best Practices For Managing Human–Beaver Conflicts In North America: Balancing Ecological Benefits And Human Interests, Alec J. Sundelius, Jerry Altermatt, Doug Brimeyer, Derek J. Broman, Jared Duquette, Cory Mosby, Falyn Owens, Shawn Rossler, David B. Ruid, Brian F. Wakeling, H. Bryant White

Human–Wildlife Interactions Monographs

We explore the complexities of managing beaver (Castor canadensis) conflicts in North America, describing the most common approaches used by natural resource management agencies to address conflicts. We identify specific conflicts caused by beavers, the ecological benefits beavers provide, and the tools commonly used to address conflicts. We discuss regional differences in beaver management strategies, including ecosystem restoration and conflict prevention. We specifically discuss a variety of management practices including public education, land use management, trapping, translocation, exclusion, shooting, dam removal, repellants, and harvest incentive programs; we then review the challenges and benefits of these tools. We discuss …

Hydroxyethyl Starch And Perioperative Complications: A Systematic Review And Meta-Analysis, Daniel I Sessler, Lorenzo Pradelli, Massimiliano Povero, Daniel Chappell, E Wang

Faculty, Staff and Student Publications

Background: Based on renal injury reported in critically ill and septic patients, the U.S. Food and Drug Administration issued a black box warning regarding hydroxyethyl starch (HES 130/0.4) use in 2013 and expanded the warning to surgical and trauma patients in 2021. Similarly, the European Medicines Agency initiated withdrawal of hydroxyethyl starch in 2022. This study was a new meta-analysis focused on renal injury designed to complement a 2021 meta-analysis of perioperative hydroxyethyl starch use, adding 45 trials and 6,895 patients. The focus was acute kidney injury and preoperative-to-postoperative change in creatinine concentration in surgical patients.

Methods: This study searched …

The Fda’S New Clinical Decision Support Software Guidance And Its Implications For Artificial Intelligence, Sara Gerke

Utah Law Review

Artificial Intelligence (AI) is transforming healthcare. While the U.S. Food and Drug Administration (FDA) has authorized the marketing of more than 1,400 AI-based products classified as devices under Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act, many other AIbased products, including certain clinical decision support (CDS) software tools that provide recommendations to health care professionals about diagnosis, treatment, or prevention of a disease or condition, have been placed on the U.S. market without FDA premarket review. On January 6, 2026, the FDA issued a revised CDS Guidance, which superseded the September 28, 2022 CDS Guidance. Shortly after, the …

Synthesis Of Fe-Doped Porous Carbon Catalyst Derived From Coconut Shell Waste Using Ferric Nitrate Nonahydrate (Fe(No3)3.9h2o) As An Iron Precursor, Ilham Lestadi Putra, Sukarni Sukarni, Heru Suryanto

Journal of Mechanical Engineering Science and Technology (JMEST)

Renewable energy from lignocellulosic biomass is a promising alternative to fossil fuels. Coconut shell (CS) waste is a favorable precursor for porous carbon due to its high carbon content, abundance, and non-food nature. However, conventional biochar often has limited surface area and catalytic active sites, hindering its effectiveness as a catalyst. While Fe-based modifications are promising, the use of ferric nitrate-assisted activation of coconut-shell-derived porous carbon remains underexplored. This research focused on developing an Fe-doped porous carbon catalyst from CS via ultrasound-assisted impregnation, followed by activation in a tube furnace. CS biochar was produced through pyrolysis at 550 °C and …

September 2026 Library & Learning Newsletter, Minnesota State University, Mankato. Library & Learning Dean's Office Communication Team

Library & Learning Newsletters

PDF version of the September 2026 (Volume 5, Issue 1) Library & Learning Newsletter.

Schizophrenia Spectrum Biomarkers Consortium: Establishment Of A Biorepository For The Discovery Of Quantitative Fluid Biomarkers, Mohini Ranganathan, Susanne Jakob, Felecia Cerrato, Lia Urban Spillane, Tarlan S. Daryoush, Sophie Shuster, Katherine Dokholyan, Shaynna Herrera, Brian Koo, Clyde Markowitz, Pojen Deng, Sage Rush, Monica E. Calkins, Scott Troyan, Kosha Ruparel, Ruben C. Gur, Holly Reynolds, Claire Wegel, Matthew B. Johnson, Lauren Hom, Sam Bryant, Ross W. Mair, Randy L. Buckner, Rebecca Birnbaum, Christian G. Kohler, Cheryl M. Corcoran, Raquel E. Gur, Steven E. Hyman

Student Publications [Scholarly]

Background and Hypothesis: Schizophrenia spectrum disorders (SSDs) produce severe symptoms, disability, and premature mortality, but only partially effective symptomatic treatments exist. Treatment development is impeded by lack of insight into disease mechanisms or objective biomarkers for clinical trials. Advances in genetics and neurobiology have converged on strong pathogenic hypotheses for SSDs centered on synapse dysfunction and excessive pruning, pathogenic processes that may produce measurable proteomic evidence in cerebrospinal fluid (CSF). Leveraging design precedents from successful fluid biomarkers discovery for Alzheimer’s disease, we undertook a pilot study to test the feasibility of repeated CSF and blood samples collection from individuals with …

Beyond Regulatory Compliance: Reorienting Indonesia's Post-Mining Governance Through Ecological Justice, Suryaningsi Suryaningsi, Rosmini Rosmini, Andi Luthfi, Muhammad Sayyidus Cakrawala

Hasanuddin Law Review

Post-mining governance in coal-producing regions is often unable to translate regulatory compliance into actual ecological recovery, as evidenced by East Kalimantan's environmental challenges. Therefore, this study aimed to examine implementation gaps in Indonesia's legal framework for reclamation and propose legal reforms grounded in ecological justice. A socio-legal method was used to integrate normative analysis, semi-structured interviews with 12 multi-level stakeholders, and comparative assessments of Australia, South Africa, and India. The results identified four critical gaps, namely discrepancies between administrative compliance and ecological outcomes, inadequate financial assurance, uncertain land transfer, and fragmented institutional oversight. This study showed that regulatory compliance without …

(Wp 2026-04) The Concept Of Position And Its Ontological Meaning In The History Of Economics, John B. Davis

Economics Working Papers

This paper examines the concept of relative position in the history of economics understood as ‘being in a position’ in a structure of positions. This is first discussed in macro-distributional terms in connection with Ricardo and Marx and in micro-behavioral terms in connection with Du Bois and Veblen. The paper then discusses two recent approaches in economics that employ the concept of relative position in a combined macro-micro analysis: the capability approach and stratification economics. For explicitly ontological analysis of the concept, the paper compares three different interpretative strategies from outside economics: Cambridge social positioning theory, embodied and distributed cognition …

Characterization Of Mettl3/14-Mediated M6a Modification In Human Transcriptome Using Nanopore Direct Rna Sequencing, Emily Kurtyan, Andrew J. Stein, Kelly J. Abdalla, Zhangerjiao Yuan, Miten Jain, Fadia Ibrahim

Department of Biochemistry and Molecular Biology Faculty Papers

Post-transcriptional RNA modifications modulate diverse aspects of RNA metabolism. N6-methyladenosine (m6A), one of the most abundant internal RNA modifications, is deposited by the core methyltransferase complex, METTL3 and METTL14. Oxford Nanopore Technologies (ONT) platform permits direct, single RNA molecule sequencing while preserving native modifications. However, without rigorous benchmarking, the accuracy and reproducibility of modification detection remain uncertain. Here, we leveraged ONT to comprehensively profile bona fide m6A modifications in cellular RNAs at single-nucleotide resolution by integrating two direct RNA sequencing chemistries (RNA002 and RNA004) with the m6Anet and Dorado modification-detection models. We independently depleted METTL3 and METTL14 in human cells …

Inosine-Triphosphate-Pyrophosphatase Activity As A Potential Predictor Of Methotrexate Remission In Juvenile Idiopathic Arthritis., Sofia Sindici Forgiarini, Marianna Lucafò, Debora Curci, Davide Selvestrel, Valentina Moressa, Sofia Pagarin, Barbara Bellich, Martina Franzin, Alberto Tommasini, Mara L. Becker, Laura Ramsey, Susan D. Thompson, Carl D. Langefeld, Federica Corba, Edoardo Marrani, Gabriele Simonini, Gabriele Stocco, Giuliana Decorti, Andrea Taddio, Serena Pastore

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: Methotrexate (MTX) is the first-line therapy for juvenile idiopathic arthritis (JIA), but up to 40% of patients do not respond to it. Low inosine triphosphate pyrophosphatase (ITPA) activity has been associated with reduced clinical remission. We investigated the role and underlying mechanisms of ITPA in vitro.

METHODS: ITPA enzymatic activity was measured by high-performance liquid chromatography with ultraviolet detection in erythrocyte lysates from patients with JIA (enrolled in Trieste, Italy; Florence, Italy; and Kansas City, Missouri) receiving weekly MTX (10-15 mg/m²) for at least 12 months. Remission was evaluated by Wallace et al criteria. ITPA rs1127354, which …

Association Between Estimated Time With Low Glomerular Filtration Rate And Access To Transplant Among Youth With Advanced Chronic Kidney Disease., Elaine Ku, Timothy Copeland, Charles E. Mcculloch, Jonathan D. Savant, Bradley A. Warady, Susan L. Furth, Sarah Kizilbash, Daniel I. Feig, Roshan P. George, Joseph T. Flynn, Judith Jerry-Fluker, Matthew B. Matheson, Sandra Amaral, Ckid Investigators

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Slower chronic kidney disease (CKD) progression allows more time for transplant preparation. Whether differences in CKD progression by race/ethnicity associate with preemptive or living donor transplantation in youth has not been well studied.

METHODS: We examined the association between time spent with low eGFR (between 10-30 mL/min/1.73 m²) and odds of preemptive or living donor transplantation among youth with CKD. eGFR was estimated using the bedside Schwartz (if < 18 years) and CKD-EPI 2021 equations (if ≥ 18 years) and the CKiD U25 equation in sensitivity analysis. Time spent with low eGFR was compared by race/ethnicity.

RESULTS: Among 333 youth with CKD (median age 11 years [IQR 7,14]), median time spent with low eGFR was 28.8 months. 77% were preemptively waitlisted, and 45% received preemptive …

The Rise And Fall Of Lateral Electrical Surface Stimulation (Less) Through The Lens Of Srs Archives., Ali Rezazadeh Shirazi, Jay I. Kumar, Katie Dold, George H. Thompson, Andrew G. King, Richard M. Schwend, John P. Lubicky, Jay Shapiro, Behrooz A. Akbarnia, History Committee Of The Scoliosis Research Society

Manuscripts, Articles, Book Chapters and Other Papers

PURPOSE: Lateral electrical surface stimulation (LESS), commercially known as the ScoliTron™, emerged in the late 1970s as a noninvasive alternative to bracing for adolescent idiopathic scoliosis. Early clinical reports generated considerable enthusiasm and adoption, but the technique was ultimately abandoned. This study examined the rise and fall of LESS through a combined analysis of the Scoliosis Research Society (SRS) archives and published literature, with the goal of understanding factors that influence the adoption, evaluation, and abandonment of innovation in scoliosis care.

METHODS: A structured historical review was conducted using archival materials from the Scoliosis Research Society (SRS), including meeting abstracts, …

The Damage Done: How The Disease Model Of Addiction Harms Marginalized People In Canada, Sara Gordon

UBC Law Review

No abstract provided.

Playing Pretend: Why Indigenous Identity Fraud Demands A Crime, Olivia Meier

UBC Law Review

No abstract provided.

Rebutting 38 False Claims About Solar, Wind, Electric Vehicles, And Battery Storage, Andrew Kieffer

Sabin Center for Climate Change Law

Achieving the United States’ ambitious emissions reduction goals depends in large part on the rapid adoption of wind and solar energy and the electrification of consumer vehicles. However, misinformation and coordinated disinformation about renewable energy is widespread and threatens to undermine the transition. In this report, the Sabin Center identifies and examines 38 of the most pervasive false claims about solar energy, wind energy, and electric vehicles, with the aim of promoting a more informed discussion.

2026 Annual Report – Celebrating 40 Years Of Research Excellence, Melissa Weddell

Institute for Tourism and Recreation Research Publications

This report marks the 40th anniversary of the Institute for Tourism and Recreation Research (ITRR) at the University of Montana, founded in 1987 as the research arm of the state's tourism and recreation industries and funded through a small share of the Lodging Facility Use Tax.

It covers the 2025 travel year, when 13.2 million nonresident visitors spent $5.6 billion in Montana, supporting 52,610 jobs and $360 million in state and local tax revenue. Featured studies cover the state's museums and paleontological sites, its $1.27 billion outfitting and guiding industry, and tourism's growing role in Eastern Montana's rural economies. Additional …

Longitudinal Association Between Midlife Cardiovascular Health And Cognitive Change In A Bi-Ethnic Cohort, Janette Vazquez, Rebecca Bernal, Luis Aguirre, Jesus D. Melgarejo, Gladys Maestre, Sudha Seshadri, Helen P. Hazuda, Chen-Pin Wang, Claudia Satizabal

School of Medicine Publications

Introduction: Midlife cardiovascular burden contributes to cognitive decline and dementia. However, research in diverse populations remains scarce.

Methods: We included 402 San Antonio Heart Study participants (1979–1988; midlife mean age 57.9 ± 3.8, 58.5% women, 52% Mexican American) later enrolled in the San Antonio Longitudinal Study of Aging (1992–2004). Midlife cardiovascular health was assessed using Life's Simple 7. Cognition was measured up to four times with the Mini-Mental State Examination. Generalized estimating equation models adjusted for age, sex, income, and education were used to relate cardiovascular factors to cognitive change. Sensitivity analyses evaluated attrition bias.

Results: Physical activity was associated …

Patient-Specific Computational Fluid Dynamics Modeling Of Airway Collapse In Infants With Robin Sequence., Gautam Jalori, Michael Barbour, Michael Bindschadler, Kelly Evans, John P. Dahl, Alberto Aliseda

Manuscripts, Articles, Book Chapters and Other Papers

Robin Sequence (RS) is a congenital condition in which patients experience dynamic, periodic obstruction or collapse of the upper airway due to an underdeveloped jaw and a posteriorly displaced tongue. Current clinical techniques for evaluating airway obstruction do not provide quantifiable data and fail to account for the dynamic nature of obstruction or collapse. There is no standardized criterion to characterize obstruction or collapse severity. This study presents the first method that extracts airway motion from 4-dimensional computed tomography and performs a patient-specific, moving-mesh computational fluid dynamics (CFD) analysis of RS patients with complete airway collapse or obstruction. To quantify …