Law Commons^™

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 …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo

Mary Jane Angelo

This paper examines the EPA's new policy regulating plant pesticides and presents the legal, scientific and policy issues surrounding the regulation of genetically engineered plants. Part I introduces the concepts covered in this paper. Part II.A. discusses products that have originated from biotechnology. Part II.B. describes the EPA's legal authority for regulating plant pesticides and other biotechnology products. Part II.C. presents the history of federal regulation of biological pesticides and biotechnology products. Part III examines the controversy surrounding the use of genetically engineered plants, including the potential risks and benefits of genetically engineered plants and the public's perception of these …

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio

Law Student Publications

This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …

The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven

Journal of Health Care Law and Policy

No abstract provided.

Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo

UF Law Faculty Publications

This paper examines the EPA's new policy regulating plant pesticides and presents the legal, scientific and policy issues surrounding the regulation of genetically engineered plants. Part I introduces the concepts covered in this paper. Part II.A. discusses products that have originated from biotechnology. Part II.B. describes the EPA's legal authority for regulating plant pesticides and other biotechnology products. Part II.C. presents the history of federal regulation of biological pesticides and biotechnology products. Part III examines the controversy surrounding the use of genetically engineered plants, including the potential risks and benefits of genetically engineered plants and the public's perception of these …

The Food And Drug Administration And The Economic Adulteration Of Foods, Wesley E. Forte

Indiana Law Journal

No abstract provided.