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Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Catholic University Law Review
The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …
The Minty Taste Of Death: State And Local Options To Regulate Menthol In Tobacco Products, Michael Freiberg
The Minty Taste Of Death: State And Local Options To Regulate Menthol In Tobacco Products, Michael Freiberg
Catholic University Law Review
Explaining why the additive menthol in tobacco products creates major public health risks, this article advocates for restricting the addition of menthol in cigarettes as a way to reduce smoking-related disease and death. Author Michael Freiberg describes how the decision to regulate menthol in tobacco products, on a federal level, was historically delegated by Congress to the discretion of the U.S. FDA, outlines the U.S. FDA’s subsequent failure to regulate menthol, and surveys state and local government efforts to regulate menthol in response to the FDA’s inaction. The article proposes additional actions that these state and local governments could take …
Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller
Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller
Catholic University Law Review
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