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Articles 1 - 9 of 9
Full-Text Articles in Law
Pandemic Politics, Public Health, And The Fda, Jordan Paradise, Becky Bavlsik
Pandemic Politics, Public Health, And The Fda, Jordan Paradise, Becky Bavlsik
Faculty Publications & Other Works
No abstract provided.
Insulin Federalism, Jordan Paradise
Insulin Federalism, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider
Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider
Faculty Publications & Other Works
The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.
The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …
Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise
Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise
Faculty Publications & Other Works
In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …
Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester
Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester
Faculty Publications & Other Works
No abstract provided.
Regulatory Silence At The Fda, Jordan Paradise
Regulatory Silence At The Fda, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise
Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise
Faculty Publications & Other Works
The U.S. Food and Drug Administration has created an online platform for the next generation sequencing community, enabling users to evaluate biomarker information and share resources. This article examines this online platform and offers several observations about potential legal and regulatory implications.
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise
A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.