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Articles 1 - 30 of 33
Full-Text Articles in Law
Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings
Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings
Richmond Journal of Law & Technology
Some of the most dynamic areas of robotics research and development today are healthcare applications. Robot-assisted surgery, robotic nurses, in-home rehabilitation, and eldercare robots' are all demonstrating rapidly iterating innovation. Rising healthcare labor costs and an aging population will increase demand for these human surrogates and enhancements. However, like many emerging technologies, robots are difficult to place within existing regulatory frameworks. For example, the federal Food, Drug, and Cosmetic Act (FD&C Act) seeks to ensure that medical devices (few of which are consumer devices) are safe, the HIPAA Privacy and Security Rules apply to data collected by health care providers …
The Executioner's Dilemmas, Eric Berger
The Executioner's Dilemmas, Eric Berger
University of Richmond Law Review
No abstract provided.
The Internet Of Things And Wearable Technology: Addressing Privacy And Security Concerns Without Derailing Innovation, Adam D. Thierer
The Internet Of Things And Wearable Technology: Addressing Privacy And Security Concerns Without Derailing Innovation, Adam D. Thierer
Richmond Journal of Law & Technology
The next great wave of Internet-enabled innovation has arrived, and it is poised to revolutionize the way humans interact with the world around them. This paper highlights some of the opportunities presented by the rise of the so-called Internet of Things (IoT) in general and wearable technology in particular and encourages policymakers to allow these technologies to develop in a relatively unabated fashion.
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
University of Richmond Law Review
No abstract provided.
The Penumbra Of The United States’ Foreign Corrupt Practices Act: Brazil’S Clean Companies Act And Implications For The Pharmaceutical Industry, Beverley Earle, Anita Cava
The Penumbra Of The United States’ Foreign Corrupt Practices Act: Brazil’S Clean Companies Act And Implications For The Pharmaceutical Industry, Beverley Earle, Anita Cava
Richmond Journal of Global Law & Business
No abstract provided.
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio
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 …
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
Law Student Publications
This article explores whether a graphic warning is possible or preferable in the government's fight against tobacco. Part II outlines a brief history of tobacco regulation in the United States. Part III turns to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and the FDA's initial rulemaking process. Part IV outlines the doctrine of commercial free speech, and Part V discusses why the Rule faced insurmountable challenges under this jurisprudence. Part VI explores how the FDA may overcome these hurdles in its future rulemaking, while Part VII discusses alternative methods through which the government can pursue its anti-tobacco agenda …
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
University of Richmond Law Review
No abstract provided.
Advancing An Adaptive Standard Of Strict Scrutiny For Content-Based Commercial Speech Regulation, Nat Stern, Mark Joseph Stern
Advancing An Adaptive Standard Of Strict Scrutiny For Content-Based Commercial Speech Regulation, Nat Stern, Mark Joseph Stern
University of Richmond Law Review
No abstract provided.
A Vaccine Approach To The Reverse Payment Illness, Scott Bergeson
A Vaccine Approach To The Reverse Payment Illness, Scott Bergeson
Richmond Journal of Law & Technology
Big Brand Name develops and files a patent for a drug that kills bacteria in an innovative way. The drug is groundbreaking and potentially marketable, so Big Brand Name incurs the enormous cost (estimated at $868 million) and time of drug discovery research and safety determinations of clinical trials to bring the drug to market. Small Generic Company wants to sell the same drug but must wait until Big Brand Name’s patent expires or, in the alternative, Small Generic Company can file an Abbreviated New Drug Application (“ANDA”) with the FDA and allege Big Brand Name’s patent is invalid or …
The Regulation Of Nanomedicine: Will The Existing Regulatory Scheme Of The Fda Suffice?, Shanna Harris
The Regulation Of Nanomedicine: Will The Existing Regulatory Scheme Of The Fda Suffice?, Shanna Harris
Richmond Journal of Law & Technology
Nanotechnology is the science and technology of manipulating molecules and atoms at the molecular level to create devices with new molecular properties, organizations and functions.1 Devices such as new computers that are billions of times more powerful than any currently available2 and boxes the size of sugar cubes that can hold the entire content of the Library of Congress are examples of the power of nanotechnology.
Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort
Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort
Richmond Journal of Law & Technology
The Hatch-Waxman Act provides a mandatory thirty-month stay on the Food and Drug Administration’s (FDA) approval of an Abbreviated New Drug Application (ANDA) when a patent infringement suit is filed. The Act includes a provision for a district court to shorten or extend the Act’s thirty-month stay on FDA approval if “either party to the action failed to reasonably cooperate in expediting the action”
Emerging Biotechnologies Demand Defeat Of Proposed Legislation That Attempts To Ban Gene Patents, Gregory C. Ellis
Emerging Biotechnologies Demand Defeat Of Proposed Legislation That Attempts To Ban Gene Patents, Gregory C. Ellis
Richmond Journal of Law & Technology
In October 2006, Andrew Fire and Craig Mello won the Nobel Prize in Physiology or Medicine for discovering a process known as RNA interference in the soil nematode Caenorhaditis elegans. More commonly known as RNAi, this process has great therapeutic significance for humans because of its ability to specifically and efficiently regulate gene expression. The capacity to easily regulate gene expression will tremendously impact our ability to combat a wide variety of disorders ranging from cancer to infectious diseases. While the mechanism of RNAi was first published within the last decade, three RNAi-based human therapies are already in clinical trails.
Fda Regulatory Compliance Reconsidered, Carl W. Tobias
Fda Regulatory Compliance Reconsidered, Carl W. Tobias
Law Faculty Publications
Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA's regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers' liability …
How Does My Work Become Our Work? Dilution Of Authorship In Scientific Papers, And The Need For The Academy To Obey Copyright Law, Sean B. Seymore
How Does My Work Become Our Work? Dilution Of Authorship In Scientific Papers, And The Need For The Academy To Obey Copyright Law, Sean B. Seymore
Richmond Journal of Law & Technology
Professors enjoy a world of extensive institutional autonomy and individual academic freedom. Universities and courts defer to a professor’s judgment for “genuinely academic decisions” unless they depart from academic norms. Universities, courts, and professional societies should intervene, however, when academic norms and custom do not comport with the law.
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
University of Richmond Law Review
No abstract provided.
Remarks On Regulating Genetically Modified Foods In The United States, L. Val Giddings
Remarks On Regulating Genetically Modified Foods In The United States, L. Val Giddings
Richmond Journal of Law & Technology
Thank you. I’m glad to be here today. Before I launch into my prepared remarks, I do want to correct a couple of things that Greg has just told you. Just for full disclosure, Greg and I shared an office about eighteen years ago when we both worked for the Congressional Office of Technology Assessment. When I arrived in Washington, I spent five years working as an analyst on these sorts of issues. So as I’m about to pound on Greg for knowing a number of things that don’t happen to be true, please be aware that I’m not really …
Panel Remarks On Regulating Genetically Modified Foods In The United States, L. Val Giddings, Gregory Jaffe, David Hegewood, Kathleen Hart
Panel Remarks On Regulating Genetically Modified Foods In The United States, L. Val Giddings, Gregory Jaffe, David Hegewood, Kathleen Hart
Richmond Journal of Law & Technology
Thank you all. In my opinion, containment of pharmaceutical GM crops is essential and hard to do. The USDA just recently came up with some new guidelines for genetically modified pharm plants, but how can the public have an input into what’s going on if they don’t even know where the crops are growing, or what’s in the crops, because this is protected as confidential business information? Should the public have a say? How would we accomplish--giving the public a say about whether they want genetically engineered wheat, even aside from the export issues. Third, I understand GE salmon is …
Panel Remarks On Liability: Liability For Farming?, Rachel G. Lattimore
Panel Remarks On Liability: Liability For Farming?, Rachel G. Lattimore
Richmond Journal of Law & Technology
Good afternoon. To begin, I’d like to thank Ed Wallis and the Richmond Journal of Law & Tech- nology for inviting me to speak on such a distinguished panel. And I’d like to tell you one thing about myself that is not in my fancy lawyer biography. I grew up on a small family farm down in North Caro- lina, so I learned from an early age about the different types of genetic manipulations that go on a farm, from breeding cattle to grafting apple trees, which if you’re fourteen years old, consists of spending your entire Spring Break taking …
Remarks On Food Safety In Dealing With Genetically Modified Foods, Dallas Hoover
Remarks On Food Safety In Dealing With Genetically Modified Foods, Dallas Hoover
Richmond Journal of Law & Technology
It’s nice to be here, and I appreciate the opportunity to talk with you all. It’s my first time in a School of Law and you certainly have more wood in your rooms than we do in laboratories, so this is a different experience for me. I’m a food microbiologist by training, so to me, food safety means Salmonella and cantaloupe and viruses in cruise ships. With genetically engineered foods, it’s a little bit different because the effects aren’t as dramatic as far as safety issues as what I see in my daily professional life. Also, it’s different because genetically …
An Introduction To Genetically Modified Foods, Kathleen Hart
An Introduction To Genetically Modified Foods, Kathleen Hart
Richmond Journal of Law & Technology
Thank you. I have been visiting a lot of bookstores since Eating in the Dark came out last year, including a wonderful bookstore, I should mention, which is right here in Richmond called the Fountain Bookstore. People often ask me if I’ve changed my diet as a result of what I learned while researching the book. Mainly, have I stopped eating genetically engineered foods? I always answer that I’m an American, so of course I eat genetically engineered foods because we have no choice in the matter. GM foods are ubiquitous in the processed foods, and they’re not labeled. But …
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Gregory Conko
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Gregory Conko
Richmond Journal of Law & Technology
Thank you. It’s a very common mistake to believe that consumers could only have a choice if the government requires mandatory labeling of genetically engineered food. My question back to you, Jean, is, exactly what kind of information do consumers get if all you do is label the product as “Genetically Engineered?” We can take this up later in the debate part of our panel discussion. I think the one thing that we can all agree on, however, is that the food label is a very important source of information to consumers.
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jonathan Adler
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jonathan Adler
Richmond Journal of Law & Technology
Thank you. It’s a pleasure to be here, and I appreciate the invitation. What I want to talk about are some legal issues relating to labeling and, in particular, constitutional issues relating to mandatory labeling for genetically modified foods or food products that may contain genetically modified components. This is a separate issue from whether or not the FDA, or some other agency, has sufficient statutory authority at present to mandate labeling, and that is something worth discussing. Even if they do have such authority, or even if Congress tomorrow were to give the FDA such authority or were to …
Panel Remarks On Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Michael Rodemeyer, Jonathan Adler, Greg Conko, Jean Halloran
Panel Remarks On Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Michael Rodemeyer, Jonathan Adler, Greg Conko, Jean Halloran
Richmond Journal of Law & Technology
Thank you to all of our speakers. I can assure everybody in the audience that you will not be specialists on this topic after today, since we can easily spend a whole afternoon on this topic. Let me ask Jean first of all, do you want to respond to anything you’ve heard from the speakers after you?
Panel Remarks On Liability: Liability For Refusing To Use Agricultural Biotechnology, Drew Kershen
Panel Remarks On Liability: Liability For Refusing To Use Agricultural Biotechnology, Drew Kershen
Richmond Journal of Law & Technology
Good afternoon. I’m very pleased to be here. I appreciate the offer and the invitation from the Richmond Journal of Law & Technology to speak at this conference. This final panel is really about liability issues related to genetically modified foods or transgenic crops. Now I just want to quickly introduce these three people, and I’m going to start on my far side with Rachel Lattimore. Rachel Lattimore is a lawyer with the firm of Arent Fox in Washington D.C., and she is going to focus her talk – and we’ve sort of agreed among ourselves so we don’t step …
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jean Halloran
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jean Halloran
Richmond Journal of Law & Technology
hank you. Consumer Union, which is the organization that I work for, favors labeling genetically engineered food. At the base of our view on this issue is the view that genetically engineered food is different than regular food. I know some of our previous speakers have spoken about how this is all just one big continuum from conventional crops, but when you look at spider- silk goats, which are goats genetically engineered to produce spider silk in their milk that do in fact exist already on a test farm, the ordinary persons sees something different. To the ordinary person, a …
Remarks On Regulating Genetically Modified Foods In The United States, Gregory Jaffe
Remarks On Regulating Genetically Modified Foods In The United States, Gregory Jaffe
Richmond Journal of Law & Technology
Thank you very much for inviting me here today. I’m going to use PowerPoint here, but I will try to keep my comments brief. I’m going to spend just a minute or two introducing my organization to you and our biotech project. Then I’m going to talk a little about the regulatory system and what I see are some of the inadequacies in the current regulatory environment for agricultural biotechnology.
Remarks On Regulating Genetically Modified Foods In The United States, David Hegewood
Remarks On Regulating Genetically Modified Foods In The United States, David Hegewood
Richmond Journal of Law & Technology
I would like to thank the Richmond Journal of Law & Technology for inviting me this afternoon and for organizing this forum. I’ve never been on Crossfire, and it’s easy to see why Val has, so I probably won’t be quite as entertaining. In fact most of what I wanted to say this afternoon has already been said in one form or another. Val just stole the last one with the Watson and Crick Fiftieth Anniversary. What I want to do is maybe give you more of a sense of perspective and then go over some of the facts.
Case Analysis - In Re Buspirone Patent And Antitrust Litigation, Tim Meade
Case Analysis - In Re Buspirone Patent And Antitrust Litigation, Tim Meade
Richmond Journal of Law & Technology
Section 1 of the Sherman Act criminalizes any conspiracy to restrain trade or commerce within the United States or with foreign nations. Section 2 of the Sherman Act criminalizes any attempt to monopolize any part of trade or commerce within the Unites Stated or with foreign nations.
Will A Lawsuit A Day Keep The Cyberdocs Away? Modern Theories Of Medical Malpractice As Applied To Cybermedicine, Ruth Ellen Smalley
Will A Lawsuit A Day Keep The Cyberdocs Away? Modern Theories Of Medical Malpractice As Applied To Cybermedicine, Ruth Ellen Smalley
Richmond Journal of Law & Technology
Rivaled only by lawyers, those who earn their livelihood by practicing medicine are viewed by many as America's Public Enemy No. 1. This perception is due to the rising cost of medicine, the over-scheduling of patients, and the poor bedside manner that many people associate with a trip to the doctor's office. However, the advent of the Internet and its proliferation into schools, offices, and homes has placed medical opinions only a mouse click away. Websites, such as cyberdocs.com, allow patients to type in a description of their ailments and receive diagnoses and treatment advice from an on-line medical professional …