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Articles 1 - 6 of 6
Full-Text Articles in Law
Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen
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 …
Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz
Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz
Faculty Scholarship
In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …
The Hidden Daubert Factor: How Judges Use Error Rates In Assessing Scientific Evidence, John B. Meixner Jr., Shari Seidman Diamond
The Hidden Daubert Factor: How Judges Use Error Rates In Assessing Scientific Evidence, John B. Meixner Jr., Shari Seidman Diamond
Scholarly Works
In Daubert v. Merrell Dow Pharmaceuticals, the United States Supreme Court provided a framework under which trial judges must assess the evidentiary reliability of scientific evidence whose admissibility is challenged. One factor of the Daubert test, the “known or potential rate of error” of the expert’s method, has received considerably less scholarly attention than the other factors, and past empirical study has indicated that judges have a difficult time understanding the factor and use it less frequently in their analyses as compared to other factors. In this paper, we examine one possible interpretation of the “known or potential rate of …
Law And Neuroscience: Recommendations Submitted To The President's Bioethics Commission, Owen D. Jones, Richard J. Bonnie, B. J. Casey, Andre Davis, David L. Faigman, Morris Hoffman, Read Montague, Stephen J. Morse, Marcus E. Raichle, Jennifer A. Richeson, Elizabeth Scott, Laurence Steinberg, Kim Taylor-Thompson, Anthony Wagner, Gideon Yaffe
Law And Neuroscience: Recommendations Submitted To The President's Bioethics Commission, Owen D. Jones, Richard J. Bonnie, B. J. Casey, Andre Davis, David L. Faigman, Morris Hoffman, Read Montague, Stephen J. Morse, Marcus E. Raichle, Jennifer A. Richeson, Elizabeth Scott, Laurence Steinberg, Kim Taylor-Thompson, Anthony Wagner, Gideon Yaffe
All Faculty Scholarship
President Obama charged the Presidential Commission for the Study of Bioethical Issues to identify a set of core ethical standards in the neuroscience domain, including the appropriate use of neuroscience in the criminal-justice system. The Commission, in turn, called for comments and recommendations. The MacArthur Foundation Research Network on Law and Neuroscience submitted a consensus statement, published here, containing 16 specific recommendations. These are organized within three main themes: 1) what steps should be taken to enhance the capacity of the criminal justice system to make sound decisions regarding the admissibility and weight of neuroscientific evidence?; 2) to what extent …
Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope
Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope
Georgetown Law Faculty Publications and Other Works
The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …
Detecting Knowledge Of Incidentally Acquired, Real-World Memories Using A P300-Based Concealed-Information Test, John B. Meixner Jr., J. Peter Rosenfeld
Detecting Knowledge Of Incidentally Acquired, Real-World Memories Using A P300-Based Concealed-Information Test, John B. Meixner Jr., J. Peter Rosenfeld
Scholarly Works
Autobiographical memory for events experienced during normal daily life has been studied at the group level, but no studies have yet examined the ability to detect recognition of incidentally acquired memories among individual subjects. We present the first such study here, which employed a concealed-information test in which subjects were shown words associated with activities they had experienced the previous day. Subjects wore a video-recording device for 4 hr on Day 1 and then returned to the laboratory on Day 2, where they were shown words relating to events recorded with the camera (probe items) and words of the same …