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A Primer Of Medical Device Regulation: How To Go From Reactive To Proactive To Better Protect Patient Safety, Sneha Dave, Rita F. Redberg Sep 2026

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 …


Medical Device Regulation: We Can’T Just Go Back (Nor Should We), George Horvath Sep 2026

Medical Device Regulation: We Can’T Just Go Back (Nor Should We), George Horvath

Utah Law Review

For much of the twentieth century, the federal Food and Drug Administration maintained its reputation as the preeminent regulatory agency, renowned for providing vigilant and scientifically rigorous oversight that ensured the safety and effectiveness of drugs and medical devices. But a former FDA commissioner recently lamented that “[t]he FDA as we’ve known it is finished.” Many commentators have raised concerns that reductions in force will leave the Agency understaffed, that these shortages will prolong review times, and that the standards applied to premarket evaluations of medical products will allow unsafe and ineffective products to reach the market. But in the …


Post-Approval Problems, Anjali D. Deshmukh M.D., J.D. Sep 2026

Post-Approval Problems, Anjali D. Deshmukh M.D., J.D.

Utah Law Review

Sitting across from 4-year-old Jessica’s parents, I whispered the truth: the most promising drug to fight their daughter’s disease was a therapy approved for adults, not for children her age. We could estimate the dose, monitor her organs, and hope the toxicity would not outpace the benefits, but there was no high-quality clinical trial data proving it was safe for kids like her yet, despite congressional mandates. Unexpected safety issues are often identified after drugs are approved and used outside of a closely controlled clinical trial, especially in understudied populations like children, the elderly, and pregnant women. When I asked …


Kin 321.03: Physiology Of Exercise Laboratory, Alejandro M. Rosales Sep 2026

Kin 321.03: Physiology Of Exercise Laboratory, Alejandro M. Rosales

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Ahat 324.00: Assessment Of The Extremities, Melanie L. Mcgrath Sep 2026

Ahat 324.00: Assessment Of The Extremities, Melanie L. Mcgrath

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Phar 571.00: Integrated Studies V, Kendra A. Proacci, Andrew J. Eberling Sep 2026

Phar 571.00: Integrated Studies V, Kendra A. Proacci, Andrew J. Eberling

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Kin 320.01: Exercise Physiology, Charles L. Dumke Sep 2026

Kin 320.01: Exercise Physiology, Charles L. Dumke

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Kin 447.01: Professional Writing In Integrative Physiology, Melanie L. Mcgrath Sep 2026

Kin 447.01: Professional Writing In Integrative Physiology, Melanie L. Mcgrath

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Ahat 343.01: Therapeutic Interventions - Lab, Nick Cromidas Sep 2026

Ahat 343.01: Therapeutic Interventions - Lab, Nick Cromidas

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Kin 105.01: Foundations Of Exercise Science, Melanie L. Mcgrath Sep 2026

Kin 105.01: Foundations Of Exercise Science, Melanie L. Mcgrath

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Hhp 529.01: Advanced Exercise Physiology I, Charles L. Dumke Sep 2026

Hhp 529.01: Advanced Exercise Physiology I, Charles L. Dumke

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Hhp 526.01: Higher Education Pedagogy In Integrative Sciences, Valerie J. Moody Sep 2026

Hhp 526.01: Higher Education Pedagogy In Integrative Sciences, Valerie J. Moody

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Ahat 342.01: Therapeutic Interventions, Nick Cromidas Sep 2026

Ahat 342.01: Therapeutic Interventions, Nick Cromidas

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Kin 321.04: Physiology Of Exercise Laboratory, Aspen T. Lockwood, Reese B. Fledderjohn Sep 2026

Kin 321.04: Physiology Of Exercise Laboratory, Aspen T. Lockwood, Reese B. Fledderjohn

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Ahat 479.B01: Topics In Sports Medicine, Mitchell Willert, Dustin Burton Sep 2026

Ahat 479.B01: Topics In Sports Medicine, Mitchell Willert, Dustin Burton

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Phar 550.01: Drug Literature Evaluation, Sherrill J. Brown, David D. Allen, Staci L. Hemmer Sep 2026

Phar 550.01: Drug Literature Evaluation, Sherrill J. Brown, David D. Allen, Staci L. Hemmer

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Kin 321.01: Physiology Of Exercise Laboratory, Rachel E. Perez Sep 2026

Kin 321.01: Physiology Of Exercise Laboratory, Rachel E. Perez

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Kin 205.01: Foundations Of Integrative Physiology And Athletic Training, Melanie L. Mcgrath Sep 2026

Kin 205.01: Foundations Of Integrative Physiology And Athletic Training, Melanie L. Mcgrath

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Phar 350.01: Introduction To Drug Information, Sherrill J. Brown, David D. Allen, Monica A. Serban Sep 2026

Phar 350.01: Introduction To Drug Information, Sherrill J. Brown, David D. Allen, Monica A. Serban

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Phar 550.02: Drug Literature Evaluation, Sherrill J. Brown, David D. Allen, Staci L. Hemmer Sep 2026

Phar 550.02: Drug Literature Evaluation, Sherrill J. Brown, David D. Allen, Staci L. Hemmer

University of Montana Course Syllabi, 2026-2030

No abstract provided.


Sensation And Perception V3, Todd A. Kahan Sep 2026

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.


States Of Disarray: Cleaning Data For Gerrymandering Analysis, Ananya Agarwal, Fnu Alusi, Arbie Hsu, Arif Syraj, Ellen Veomett Sep 2026

States Of Disarray: Cleaning Data For Gerrymandering Analysis, Ananya Agarwal, Fnu Alusi, Arbie Hsu, Arif Syraj, Ellen Veomett

The Mathematics Enthusiast

The mathematics of redistricting is an area of study that has exploded in recent years. In particular, many different research groups and expert witnesses in court cases have used outlier analysis to argue that a proposed map is a gerrymander. This outlier analysis relies on having an ensemble of potential redistricting maps against which the proposed map is compared. Arguably the most widelyaccepted method of creating such an ensemble is to use a Markov Chain Monte Carlo (MCMC) process. This process requires that various pieces of data be gathered, cleaned, and coalesced into a single file that can be used …


The Irrationality Of The California Gubernatorial Recall System, Wesley H. Hollday, Eric Pacuit Sep 2026

The Irrationality Of The California Gubernatorial Recall System, Wesley H. Hollday, Eric Pacuit

The Mathematics Enthusiast

We analyze California’s gubernatorial recall system using basic ideas from the mathematical theory of social choice. We expose some pathologies of the system, use computer simulations to explore how often these pathologies might occur, investigate the effects of strategic voting on the analysis, and suggest changes to the system that cure the pathologies.


Can A Critical Reflection-Based Intervention Effectively Teach Intersectional Awareness Of Gendered Racism? An Empirical Study With College Students, Jayantika Chakraborty, Alena G. Esposito Sep 2026

Can A Critical Reflection-Based Intervention Effectively Teach Intersectional Awareness Of Gendered Racism? An Empirical Study With College Students, Jayantika Chakraborty, Alena G. Esposito

Psychology

Intersectional awareness of gendered racism refers to the understanding of how intersecting systems of power and inequality shape the distinct and unequal forms of discrimination experienced by women of color across social contexts. This form of awareness recognizes that racism and sexism operate jointly, producing qualitatively different experiences that vary across race, gender expression, and social location. Developing such awareness is foundational to advancing equity and has been linked to outcomes such as student activism and engagement with social justice efforts. However, empirical research examining whether and how intersectional awareness can be cultivated through educational interventions remains limited. Responding to …


Quantitative Analysis Of Blue 1 Dye In Commercial Sports Drinks By Uv -Vis Spectroscopy And Hplc-Dad, Mikayla Bush Sep 2026

Quantitative Analysis Of Blue 1 Dye In Commercial Sports Drinks By Uv -Vis Spectroscopy And Hplc-Dad, Mikayla Bush

Forensic Science Master's Projects

Food dyes are natural or synthetic substances added to foods, beverages, and cosmetics to enhance color and visual appeal. Although they provide no nutritional value, they are widely used to attract consumers, particularly children. Concerns have been raised about the potential health effects of synthetic dyes, including links to hyperactivity in children, tumor formation at high doses, and possible impacts on gut and brain function. In response, regulatory efforts are ongoing. In April 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced an initiative to phase out petroleum-based food dyes, including …


Development And Psychometric Validation With Normative Levels Of The Spotlight Effect Scale Among Students Of Physical Education And Sport Sciences, Raghda Hassan Alazawy, Mais Mahmoud Salman Alazawy Sep 2026

Development And Psychometric Validation With Normative Levels Of The Spotlight Effect Scale Among Students Of Physical Education And Sport Sciences, Raghda Hassan Alazawy, Mais Mahmoud Salman Alazawy

Modern Sport

The Spotlight Effect, defined as individuals' tendency to overestimate the extent to which others notice and evaluate them, has important implications for psychological functioning, social interaction, and performance in educational and sport environments. Despite previous studies have addressed the Spotlight Effect theoretically and empirically, no validated instrument has been specifically developed to assess this construct especially among students of Colleges of Physical Education and Sport Sciences. This study aimed to develop and validate a Spotlight Effect Scale and establishing normative levels for its interpretation. The descriptive survey approach was used, involving 555 students from Colleges of Physical Education and Sport …


Effects Of Magnesium Supplementation On Selected Strength And Speed Performance Tests In Elite Soccer Players, Dalshad Mohammed Abdulrahman Sep 2026

Effects Of Magnesium Supplementation On Selected Strength And Speed Performance Tests In Elite Soccer Players, Dalshad Mohammed Abdulrahman

Modern Sport

Magnesium supports energy metabolism, neuromuscular regulation, and muscle contraction, yet direct evidence for its supplementation benefits on explosive strength and sprint performance in elite soccer players remains limited. This study examined the effect of eight weeks of magnesium supplementation, combined with regular training, on vertical jump height and 30-m sprint performance in elite soccer players. This exploratory, open-label, randomized controlled trial used a parallel pretest–post-test design. Twenty-four first-team players from Duhok Sports Club were randomly allocated (1:1) to receive either 350 mg/day elemental magnesium (as magnesium citrate) for 8 weeks or regular training alone. Primary outcomes were vertical jump height …


Exnovation And Digital Open Innovation: A Capability Pathway From Digital Dependency To Digital Sovereignty, Areeba Abid, Balqees Almessabi, Ajmal Waheed, Noor Ul Hadi Sep 2026

Exnovation And Digital Open Innovation: A Capability Pathway From Digital Dependency To Digital Sovereignty, Areeba Abid, Balqees Almessabi, Ajmal Waheed, Noor Ul Hadi

All Works

Digital transformation in emerging economies increasingly unfolds under conditions of dependence on externally controlled platforms, infrastructures, standards, and data ecosystems. Although digital sovereignty has become a prominent policy objective, the institutional processes through which public organizations move from digital dependency toward greater governance autonomy remain insufficiently theorized. To address this gap, this study develops a conceptual framework through a concept-driven hermeneutic narrative review to explain how digital open innovation can support the development of digital sovereignty. The framework conceptualizes digital sovereignty as an institutional governance capability that emerges through a sequential process rather than as a static policy objective. Specifically, …


Governing Agentic Ai: The Human Values Alignment Framework (Hvaf-A) As A Policy Tool, Mousa Al-Kfairy Sep 2026

Governing Agentic Ai: The Human Values Alignment Framework (Hvaf-A) As A Policy Tool, Mousa Al-Kfairy

All Works

Agentic artificial intelligence (AI) systems—software that plans, acts, and decides without step-by-step human approval—are already deployed in finance, healthcare, recruitment, and public services. They differ from earlier AI in one critical way. They do not produce outputs for a human to accept or reject. They take actions. Those actions may be irreversible. They may affect people who never used the system. Existing governance frameworks were not designed for this. Current alignment approaches—including reinforcement learning from human feedback, constitutional AI, and preference aggregation—assume that a well-aligned system satisfies what users ask for. This paper argues that the assumption fails in agentic …


Individualized Bayesian Inference Identifies Novel Genetic Variants For Parkinson's Disease, Jin Ren, Yasaman J. Soofi, Md Asad Rahman, Qing Lu, Jinling Liu Sep 2026

Individualized Bayesian Inference Identifies Novel Genetic Variants For Parkinson's Disease, Jin Ren, Yasaman J. Soofi, Md Asad Rahman, Qing Lu, Jinling Liu

Engineering Management and Systems Engineering Faculty Research & Creative Works

Parkinson's disease (PD) is a complex neurodegenerative disorder with a significant genetic component. While genome-wide association studies (GWAS) have been instrumental in identifying genetic variants associated with PD, the reliance on large sample sizes and population-level analyses may overlook variants with lower minor allele frequencies or individual-specific relevance. Individualized Bayesian Inference (IBI) offers a promising method to complement GWAS by identifying and prioritizing candidate genetic markers at both the individual and patients-like-me subgroup levels. This study evaluates the application of IBI to PD genetics, using GWAS as a baseline for comparison. We analyzed genetic data from the Fox Insight online …