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Full-Text Articles in Law
Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil
Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil
Journal of Health Care Law and Policy
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label—does preempt state law as …
Independent Drug Testing To Ensure Drug Safety And Efficacy, Marc A. Rodwin
Independent Drug Testing To Ensure Drug Safety And Efficacy, Marc A. Rodwin
Journal of Health Care Law and Policy
This Article explores a proposal that would preclude biased drug testing by removing all drug sponsor influence on the design and conduct of clinical trials for new drug applications (“NDAs”), a reform that would address the root of institutional corruption. Recently advocated by leading scholars, the idea has a long history, yet was neglected for over half a century due to pharmaceutical industry opposition.