Browsing Harvard Law School by Title
Now showing items 1807-1826 of 2408
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Regulating Transgenic "Pharm" Plants: Pre-Commercialization Review and Post-Commercialization Monitoring
(2004)This manuscript presents an analysis of the regulation of transgenic plants that are engineered to express pharmaceutical or industrial products (referred to throughout as “pharm†plants). ... -
Regulation as Delegation
(2015)In diverse areas – from retirement savings, to fuel economy, to prescription drugs, to consumer credit, to food and beverage consumption – government makes personal decisions for us or helps us make what it sees as better ... -
Regulation in a Multisectored Financial Services Industry: An Exploratory Essay
(1999)This Article reviews differences in regulatory structure across sectors of the financial services industry in the United States and then explores the difficulties these differences pose to our current system of regulation ... -
The Regulation of Animal Welfare in Food Production
(2005)This paper surveys the various ways in which we choose to regulate, or could choose to regulate, the treatment of animals in food production. “Regulation†is broadly defined to encompass any ... -
The Regulation of Drug Manufacturing Changes: Past, Present and Foreign
(1997)This paper examines the history of FDA regulation of manufacturing supplements for drugs, summarizes the current equivalent regulations of the European Union (EU), and concludes by discussing some current proposals for ... -
Regulation of Fat Content in Food: Recent History and Cultural Commentary
(2006)Fat content in food has been one of the most hotly contested areas of nutrition labeling. This paper traces the changes in fat content labeling requirements for packaged food from the optional disclosure system in place ... -
Regulation of Genetically Engineered Food Products: A Market-Oriented Perspective
(1995)Only twenty years after the landmark Asilomar meeting where scientists discussed the opportunities and possible risks presented by the ability to transfer DNA from one organism to another,' bioengineered products have moved ... -
Regulation of Human Tissue for Transplantation
(1997)Historically the Food and Drug Administration has not regulated human tissues for transplantation, but with the pervasive scourge of AIDS and widespread public concern about preventing its transmission, pressure has mounted ... -
The Regulation of Pharmaceutical Compounding and the Determination of Need: Balancing Access and Autonomy with Patient Safety
(2004)Pharmaceutical compounding, the creation and dispensing of custom-made medications, is the root of the pharmacy profession often symbolized by the mortar and pestle. The practice involves mixing, measuring, and making safe, ... -
THE REGULATION OF SPORTS PRODUCTS AS DIETARY SUPPLEMENTS: SHOULD THE FDA HAVE STRICTER REQUIREMENTS?
(2003)Since the Food and Drug Administration (“FDAâ€) has control over the regulation of dietary supplements, this paper discusses whether the current regulation is sufficient to guard the safety ... -
The Regulation of Tea and Its Health-Related Claims in the Wake of Developing Scientific Evidence: Food, Drug, or Dietary Supplement?
(2004)This paper examines the place of tea in cultural and regulatory American society. Scientific evidence now abounds about the potential health benefits of tea, and this has put pressure on regulators at the Food and Drug ... -
The Regulation of Toothpaste
(1997)Humankind invented toothpaste for a variety of reasons, the most important of which is the prevention of this tooth decay. Usually, we, the buying public, do not see this product until it is in its familiar plastic tubing ... -
Regulations on Biotechnological Research and Biologically Modified Products
(2002)The developments in biotechnology have brought not only benefits but also harms to society. On the one hand, the biotechnologically modified products has rapidly changed our lifestyle, but on the other hand, they could ... -
The Regulatory Lookback
(2014)Technocratic judgments can have a “cooling function.” An insistent focus on the facts, and on the likely consequences of policies, might soften political divisions and produce consensus. Within the federal government, ... -
Regulatory Quality Under Imperfect Oversight
(Cambridge University Press, 2007)We analyze the positive and normative implications of regulatory oversight when the policymaking agency can improve the quality of regulation through effort, but only some kinds of effort are observable by the overseer, ... -
Regulatory Review for the States
(2014)For over thirty years, Republican and Democratic presidents have required executive agencies to assess the costs and benefits of significant regulations, and to proceed only if the benefits justify the costs (to the extent ... -
Rehabilitating Jefferson Parish: Why Ties Without a Substantial Foreclosure Share Should Not Be Per Se Legal
(Harvard John M. Olin Center for Law, Economics, and Business, 2014)Current tying law uses a bifurcated rule of reason, condemning ties that have either tying market power or a substantial tied foreclosure share, absent an offsetting procompetitive justification. Many critics of tying law ... -
Reimportation of Prescription Drugs - Legislative, Executive, Judicial and State and Local Responses
(2006)The expensive cost of prescription drugs has become a high-profile issue in the United States, challenging the government and policy-makers to create a solution that addresses all the factors involved in this issue. Creating ... -
REIMPORTATION OF U.S. PHARMACEUTICALS: POLITICAL, ECONOMIC, AND LEGAL PERSPECTIVES
(2002)The high cost of prescription drugs in the United States is a problem that has engendered much political attention. One proposed solution to the prescription drug problem is to permit reimportation of U.S.-made drug products, ... -
Reimportation: A First Step or False Step Toward Transparency in the Prescription Drug Market?
(2005)Drug reimportation has become a politically-appealing way to lower drug prices, which Americans commonly perceive as too high. However, legalizing reimportation of U.S.-approved drugs raises major concerns about safety and ...