Medicine and Health Sciences Commons^™

Estimates For Worldwide Laboratory Animal Use In 2005, Katy Taylor, Nicky Gordon, Gill Langley, Wendy Higgins

Gill Langley, PhD

Animal experimentation continues to generate public and political concern worldwide. Relatively few countries collate and publish animal use statistics, yet this is a first and essential step toward public accountability and an informed debate, as well as being important for effective policy-making and regulation. The implementation of the Three Rs (replacement, reduction and refinement of animal experiments) should be expected to result in a decline in animal use, but without regular, accurate statistics, this cannot be monitored. Recent estimates of worldwide annual laboratory animal use are imprecise and unsubstantiated, ranging from 28–100 million. We collated data for 37 countries that …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

All Faculty Scholarship

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.

As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …

Slides: Details Of The Regulatory Framework: Air Quality Regulation Of Oil And Gas Development, Olivia D. Lucas

Water and Air Quality Issues in Oil and Gas Development: The Evolving Framework of Regulation and Management (Martz Summer Conference, June 5-6)

Presenter: Olivia D. Lucas, Esq., Counsel, Faegre Baker Daniels

22 slides

Probiotics: Finding The Right Regulatory Balance, Diane E. Hoffmann, Claire M. Fraser-Liggett, Frank B. Palumbo, Jacques Ravel, Karen H. Rothenberg, Virginia Rowthorn

Karen H. Rothenberg

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated.

Probiotics: Finding The Right Regulatory Balance, Diane E. Hoffmann, Claire M. Fraser-Liggett, Frank B. Palumbo, Jacques Ravel, Karen H. Rothenberg, Virginia Rowthorn

Virginia Rowthorn

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated.

Differential Regulation Of Iress In The Aurora A Mrna By Bfgf Through The Mtor Complex Torc2 Modulates Aurora A Kinase Expression, Roy L. Voice Iii

Dissertations & Theses (Open Access)

Identifying the mechanisms that contribute to tumorigenesis is a major area of focus in our fight against cancer. Epithelial malignant tumors, such as breast, colon, ovarian and pancreatic cancers have been shown to overexpress proteins that control cell mitosis, growth, and proliferation. One of those proteins is the Aurora A kinase. Aurora A kinase is a member of a small family of kinases that contribute to mitotic events such as centrosome duplication, separation, and maturation. Aurora A overexpression leads to genomic instability, which can contribute to tumorigenesis, on the other hand, inhibiting Aurora A expression leads to apoptosis, making it …

The Fda Funding Crisis, Judith Alphonse, Sireesha Bellam, Marlene Fernandez, Anishka Gilbert, Lauren Roper, Antonia Zapantis, Robert C. Speth

HPD Articles

The role of the Food and Drug Administration (FDA) is to ensure the safety of prescription and nonprescription drugs, dietary supplements, and the food supply, representing more than 20% of US consumer spending. The increased need to monitor imported drugs, drug products and foods, drug shortages, and compounding pharmacies bring the adequacy of FDA funding into question. Performing even at status quo cannot be accomplished if responsibilities increase without equitable funding increases: both from the federal government and fees imposed on FDA-regulated industries. Additionally, scientific advancement, new legislation, and new industries are continually increasing the FDA workload, necessitating commensurate budget …

Enforcement Of Hospital Nurse Staffing Regulations Across The United States: Progress Or Stalemate?, Teresa Serratt, Suzanne Meyer, Susan Chapman

Teresa Serratt

Enactment of hospital nurse staffing regulations was brought about by changes in the U.S. health care system that resulted in large-scale reductions in nurse staffing. These reductions came at a time when studies were highlighting inadequacies in care that caused negative patient outcomes and raised questions about the safety of hospitalized patients. Nurse staffing regulations were enacted to ensure that adequate numbers of nurses were available to provide high-quality and safe care. Although these regulations represent progress toward addressing staffing inadequacies, enforcement language is absent or weak and compliance data are either not collected or difficult to access. Explicit and …

Probiotics: Finding The Right Regulatory Balance, Diane E. Hoffmann, Claire M. Fraser-Liggett, Frank B. Palumbo, Jacques Ravel, Karen H. Rothenberg, Virginia Rowthorn

Diane Hoffmann

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated.

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

The Use Of Unregulated Staff: Time For Regulation?, Christine M. Duffield, Di E. Twigg, Judith D. Pugh, Gemma Evans, S Dimitrelis, Michael A. Roche

Research outputs 2014 to 2021

Internationally, shortages in the nursing workforce, escalating patient demands, and financial constraints within the health system have led to the growth of unlicensed nursing support workers. Recently, in relation to the largest publicly funded health system (National Health Service), it was reported that extensive substitution of registered nurses with unskilled nursing support workers resulted in inadequate patient care, increased morbidity and mortality rates, and negative nurse outcomes. We argue that it is timely to consider regulation of nursing support workers with their role and scope of practice clearly defined. Further, the addition of these workers in a complementary model of …

Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman

Stephen D Sugarman

No abstract provided.