Open Access. Powered by Scholars. Published by Universities.®
- Discipline
- Keyword
-
- FDA (6)
- Food and Drug Administration (3)
- Covid-19 (2)
- Medical devices (2)
- Precision medicine (2)
-
- 21st Century Cures Act (1)
- AI (1)
- Antitrust (1)
- Artificail intelligence (1)
- Biologics Price Competition and Innovation Act (BPCIA) (1)
- Companion diagnostics (1)
- Consolidation (1)
- Crowdsourcing (1)
- Drug prices (1)
- Drugs (1)
- Federal Trade Commission (1)
- Generic drugs (1)
- Innovation (1)
- Insulin (1)
- Mergers (1)
- Next generation sequencing (NGS) (1)
- Pandemic (1)
- Pharmaceuticals (1)
- Prescription drugs (1)
- Regulation (1)
- Right to Try Act (1)
- Risk evaluation and mitigation strategies (REMS) (1)
- U.S. Food and Drug Administration (FDA) (1)
- United States Food and Drug Administration (FDA) (1)
- Publication Year
- Publication
- Publication Type
Articles 1 - 28 of 28
Full-Text Articles in Food and Drug 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.
The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis
The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis
Loyola University Chicago Law Journal
POM Wonderful sued Coca-Cola under the Lanham Act claiming that it suffered losses due to the misleading label on Coca-Cola’s Minute Maid brand’s Pomegranate Blueberry juice blend. Reversing the Ninth Circuit’s decision in June 2014, the Supreme Court found that POM’s claim was not precluded even though the label was regulated by the FDCA. In fact, the Court acknowledged the complementary nature of private enforcement with FDA regulation, as it did in Wyeth v. Levine in 2009. This Article submits that POM exemplifies the Court’s willingness to strengthen the Lanham Act’s protections against misleading labeling, as it did the same …
Drug Tests For Welfare: Saving Taxpayer Money Or Flushing It Down The Drain?, Michelle Yoder
Drug Tests For Welfare: Saving Taxpayer Money Or Flushing It Down The Drain?, Michelle Yoder
Public Interest Law Reporter
No abstract provided.
Combating Hunger Home And Away: Tracing America's $600 Million Price Tag For Safeguarding The Right To Food In The Horn Of Africa, Natnael Moges
Combating Hunger Home And Away: Tracing America's $600 Million Price Tag For Safeguarding The Right To Food In The Horn Of Africa, Natnael Moges
Public Interest Law Reporter
No abstract provided.
Whipping A Game On Fellons: The Atf "Stash House" Cases, Tom Mcgettrick
Whipping A Game On Fellons: The Atf "Stash House" Cases, Tom Mcgettrick
Public Interest Law Reporter
No abstract provided.
Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman
Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman
Public Interest Law Reporter
No abstract provided.
Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina Mcmahon
Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina Mcmahon
Public Interest Law Reporter
No abstract provided.
Lawsuits Over Tainted Heparin Manufactured In China: Is The Fda Becoming The Global Healthcare Authority? , Christina Laga
Lawsuits Over Tainted Heparin Manufactured In China: Is The Fda Becoming The Global Healthcare Authority? , Christina Laga
Public Interest Law Reporter
No abstract provided.
House Passage Of Cheeseburger Bill Cheered On By Food Industry, Andrea Binion
House Passage Of Cheeseburger Bill Cheered On By Food Industry, Andrea Binion
Public Interest Law Reporter
No abstract provided.
Bioshield 2: A Shot In The Right Direction?, Lindsay Frank
Bioshield 2: A Shot In The Right Direction?, Lindsay Frank
Public Interest Law Reporter
No abstract provided.
The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank
The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank
Public Interest Law Reporter
No abstract provided.
Drug Price Quintuples, Does Not Invoke Federal "March-In" Protections, Zachary Ziliak
Drug Price Quintuples, Does Not Invoke Federal "March-In" Protections, Zachary Ziliak
Public Interest Law Reporter
No abstract provided.
Let The Testing Begin, Alexis Reed
To Prosecute Or Not To Prosecute: The Dilemma Posed By Pregnancy And Substance Abuse, Eileen D. Collins
To Prosecute Or Not To Prosecute: The Dilemma Posed By Pregnancy And Substance Abuse, Eileen D. Collins
Public Interest Law Reporter
No abstract provided.
Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup
Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup
Public Interest Law Reporter
No abstract provided.
Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba
Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba
Public Interest Law Reporter
No abstract provided.
When The Cure Is Worse Than The Disease: America's Failed War On Drugs, Peg Solomon
When The Cure Is Worse Than The Disease: America's Failed War On Drugs, Peg Solomon
Public Interest Law Reporter
No abstract provided.
Freedom Of Choice In Medical Treatment: Reconsidering The Efficacy Requirement Of The Fdca, Barbara J. Clinite
Freedom Of Choice In Medical Treatment: Reconsidering The Efficacy Requirement Of The Fdca, Barbara J. Clinite
Loyola University Chicago Law Journal
No abstract provided.
Use Of I.R.C. Section 6851: Exaction In The Guise Of A Tax?, John A. Scribner
Use Of I.R.C. Section 6851: Exaction In The Guise Of A Tax?, John A. Scribner
Loyola University Chicago Law Journal
No abstract provided.
Transfer Of Venue In Adulteration Seizures Under The Flood, Drug, And Cosmetic Act, Jack R. Bierig
Transfer Of Venue In Adulteration Seizures Under The Flood, Drug, And Cosmetic Act, Jack R. Bierig
Loyola University Chicago Law Journal
No abstract provided.