Browsing Harvard Law School by Keyword "regulation"
Now showing items 21-40 of 54
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THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY
(1999)This paper attempts to provide a chronological history of the significant events and influences that have shaped the regulation of biotechnology by the Federal Food and Drug Administration. This paper first chronicles the ... -
A History of Federal Control of Communicable Diseases: Section 361 of the Public Health Service Act
(2002)The federal government possesses broad powers under Section 361 of the Public Health Service Act to regulate the entry and spread of communicable diseases into and among the United States. Though this power has played a ... -
The History of Organic Food Regulation
(2001)This paper explores the growth in organic food regulation that has accompanied the corresponding growth in the overall organic food business. -
The History of the Regulation of Menstrual Tampons
(2001)This paper examines the regulation of menstrual tampons in the United States from their introduction to the market some twenty five years ago to the standards that govern them in the twenty first century. After a brief ... -
Internet Hoaxes: Public Regulation and Private Remedies
(2000)This paper begins with a brief overview of the psychology of rumor and a discussion of the impact of Internet technology on the dissemination of rumors. Part II examines the three consumer rumors presented above as case ... -
Internet Pharmacies: Regulatory Problems and Potential Solutions
(2002)This paper will analyze the growing problem “rogue†Internet pharmacies—Internet pharmacies that conduct illegal or unsafe prescribing and dispensing practices that endanger ... -
Levelling the Playing Field: the FDA's Regulation of Nicotine Dependence Products
(1999)There is a great need for the increased development and use of nicotine dependence products (NDPs) in this country. A creative regulatory approach, such as the FDA brought to tobacco regulation, could do an enormous amount ... -
The Liability of Drug Analysis from the Story of Intravenous Iodine-Contained Contrast Medium
(1999)The development of the liability of drugs is a complicated and sophisticated process, like the development of drugs. Intravenous iodine-contained contrast medium, a diagnostic drug with excellent effectiveness and unavoidable ... -
Memorandum to Internet Pharmacies: the Regulation and Enforcement of the Internet Pharmacy Industry
(2000)This memorandum discusses the regulation of, and enforcement regarding, the internet pharmacy industry. It concludes that the problem does not require additional regulation; existing laws are sufficient to protect against ... -
Mixing the Old with the New: Chinese Traditional Medicine and The Regulation of Food and Drugs in the United States
(2000)The practice of traditional Chinese healing methods has secured a small but noticeable foothold in some sectors of American society. Whether this is simply yet another incarnation of the West's centuries-old romantic ... -
THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS
(2002)This article will discuss the main mechanisms by which the United States and other countries are attempting to standardize their pharmaceutical regulations. I first explore the need for standardization and the potential ... -
“Not in a Month Without an ‘R’ in its Name”: An Historical Overview of 20th Century Seafood Regulation With a Glimpse of the Challenges at the Beginning of the 21st
(2002)Part I of this article introduces the American seafood and shellfish industry and provides some background data on the composition of the market as well as consumption patterns in the United States. Consideration is given ... -
Off-Label Use of Prescription Drugs should be Regulated by the FDA
(2003)The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) ... -
A POLICY ANALYSIS OF HOW FDA SHOULD REGULATE HUMAN BONE MARROW TRANSPLANTATION
(1995)Over the past twenty years, physicians have carried out bone marrow transplants with increasing success. As the procedure gains in acceptance and availability over the coming years, our nation will be faced with important ... -
Post-Approval Testing By Pharmaceutical Manufacturers
(2002)A pharmaceutical manufacturer currently has an incentive to remain ignorant about a drug’s side effects after the Food and Drug Administration (“FDAâ€) approves the drug for ... -
Reaping the Full Health Benefits of the Human Genome: The Duty to Warn and The Need to Establish a Comprehensive Federal Regulatory Structure for Genetic Testing
(2002)This paper discusses the need for a comprehensive federal regulatory structure governing genetic testing. Particularly, the article proposes a legal standard to govern physicians’ duty to warn their ... -
Reassessing Pre-market Regulation of Class III Medical Devices
(2003)Regulation of medical devices has evolved over the past twenty-five years. Initially, Congress created a regime where the safety and efficacy of all medical devices would be reviewed to varying degrees, depending on the ... -
Reconsidering Caffeine: An Awake and Alert New Look at America's Most Commonly Consumed Drug
(2004)Caffeine is one of the most pervasively ingested addictive substances in the United States, yet astoundingly little attention is paid to its ubiquitous presence. This Paper examines caffeine, the substance, from many ... -
Regulating Homeopathic Drugs: Pragmatic Solutions for the Food and Drug Administration
(1999)Despite the growth of both the use of homeopathic drugs and the homeopathic drug industry, the Food and Drug Administration (FDA) has not altered its regulatory scheme for homeopathic drugs. As a result, homeopathic drugs ... -
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 ...