Implications of California v. Texas for the BPCIA (Open Access)
Food and Drug Law Journal | Volume 75 | Number 4
Regulatory Agency Transparency for Drugs and Biologics: A Comparative Survey of the U.S. Food and Drug Administration, the European Medicines Agency, and Health Canada (Open Access)
Food and Drug Law Journal | Volume 75 | Number 4
How Vioxx Exposed Conflicts of Interest at the Food and Drug Administration and The New England Journal of Medicine
Food and Drug Law Journal | Volume 75 | Number 4
The Opioid Crisis and the Wrongful Conduct Rule: Does It Matter Who’s to Blame?
Food and Drug Law Journal | Volume 75 | Number 4
TaxRx: Ultra-Processed Foods, Added Sugar, and the Social Cost of Obesity
Food and Drug Law Journal | Volume 75 | Number 4
Clear Evidence Clarified (Open Access)
Clear Evidence Clarified Eric Lindenfeld ABSTRACT In 2009, the Supreme Court introduced the “clear evidence” standard for the defense of federal preemption in the pharmaceutical products liability context. For the next ten years, the contours of the standard were inconsistently applied by courts. The Supreme Court’s 2019 decision in Merck Sharp & Dohme Corp. [...]
Animal-Based Medical Diagnostics: A Regulatory Problem (Open Access)
Animal-Based Medical Diagnostics: A Regulatory Problem Matthew Avery and Makenzi Galvan ABSTRACT Fears of global pandemics due to outbreaks of highly virulent diseases like the novel Coronavirus disease of 2019 (COVID-19) have boosted interest in rapid and non-invasive diagnostics. One solution is to use animal-based diagnostics, which have the potential to be more accurate [...]
When Cows Go Oink, Pigs Go Baaa, and Sheep Go Moo: Development and Regulatory Challenges of Intentional Genomic Alterations in Animals
Food and Drug Law Journal | Volume 75 | Number 3
After the Juice Wars: The Post-POM Wonderful Legal Landscape and its Implications for FDA-Regulated Industries
After the Juice Wars: The Post-POM Wonderful Legal Landscape and its Implications for FDA-Regulated Industries Rachel Simon ABSTRACT Five years have passed since POM Wonderful LLC v. Coca-Cola Co. established that the Federal Food, Drug, and Cosmetic Act (FDCA) does not preclude Lanham Act claims targeting FDA-regulated beverages. Few scholars, however, have evaluated the [...]
Family Ties: The Familial Privacy Implications of Direct-to-Consumer Genetic Testing
Food and Drug Law Journal | Volume 75 | Number 3
