Browsing HLS Student Papers by Issue Date
Now showing items 1-20 of 498
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N2 Universal: A Case Study of an NDA
(1994)Food and drug law, like all areas of administrative law, is rife with tension among countervailing principles. The Food and Drug Administration is charged with protecting the health and safety of the American public. This ... -
The National Childhood Vaccine Act
(1994)Prior to passage of the National Childhood Vaccine Act in November 1986, manufacturers could be held strictly liable in tort for vaccine-related injuries, a lamentable situation which allegedly caused increasing prices, ... -
THE JEWISH DIETARY LAWS AND THEIR FOUNDATION
(1994)While food and drug law has made its greatest contributions to the health and welfare of society over the past two centuries, it is indisputable that the history of this body of law is much older than two hundred years.1 ... -
FOREIGN-LANGUAGE LABELING OF FOOD AND DRUGS IN THE WAKE OF RAMIREZ V. PLOUGH INC.: IS AN OFFICIAL LANGUAGE THE SOLUTION FOR AMERICA?
(1994)In 1993, the California Supreme Court handed down a decision in the case Ramirez v. Plough. Inc.1 holding that manufacturers of nonprescription drugs in that state have no duty under the tort law to print mandatory warnings ... -
THE SECLUSION AND RESTRAINT OF THE MENTALLY ILL CHILD
(1994)The Food and Drug Administration's purpose is to serve the public and protect the public health. There's a general standard of safety and effectiveness for drugs and devices set by the Food and Drug Administration. In ... -
Cardiac Catheter Reuse in An Era of Reform: Cost-Efficiency and Regulatory Policy in the Face of Scientific Uncertainty
(1994)Cardiac catheters have become an essential element of current cardiovascular practice with several hundred thousand used each year in both diagnostic and angioplasty procedures. Uke many other disposable devices they are ... -
PROFIT WINDFALL OR PATIENT WINDFALL? The Orphan Drug Act and Proposals for its Reform
(1994)The Orphan Drug Act is a statute with a noble purpose but a controversial history. Originally designed to spur research into drugs for conditions with extremely limited patient populations,~ the Act has become a highly ... -
AIDS HOME TEST KITS
(1994)Given the emphasis on private, confidential and voluntary testing, the idea of an AIDS home test kit was inevitable. What could be more private, confidential and voluntary (and profitable) than buying a test kit at a drug ... -
BST FREE: The Debate Over Whether to Allow Voluntary Labeling of Products as "BST Free" Not Derived from Dairy Cows Given the Milk Production Hormone BST
(1994)The debate over whether to label milk and other dairy products as coming from cows injected with the milk production hormone bovine somatotropin (BST or rBGH--recombinant bovine growth hormone) pits consumers, like Darlene ... -
Anti-sense And Common-sense: Regulation of Food From Genetically Engineered Plants
(1994)Genetic engineering technology has recently generated techniques for making specific and precise alterations to the genetic composition of crops grown as food for humans and animals. These advances should facilitate the ... -
A Continuing Controversy: Labeling Requirements on Irradiated Foods
(1994)For the average American. the words "radiation" and "irradiation" are apt to conjure up images of nuclear weapons. radioactive waste, x-rays. and other unpleasant materials associated with health dangers. Yet these words ... -
DISEASE-PREVENTION CLAIMS AND THE FIRST AMENDMENT: "WHO WILL PROTECT US FROM OUR PROTECTORS?"
(1994)The area of disease-prevention claims ("health claims") for food poses a broad spectrum of dilemmas that often arise in the food and drug law area and in other regulatory situations. These recurring questions include: How ... -
PBM and Pharmaceutical Company Mergers: Policy and Regulatory Implications
(1994)A recent trend in the pharmaceutical industry has been for large pharmaceutical companies to acquire or merge with PBMs (prescriptionlpharmacy-benefits-management companies). Merck started this trend in November 1993 by ... -
RU 486: A LESSON IN RESPONSIBILITY AND ACCOUNTABILITY
(1994)The current controversy surrounding the introduction of the French abortifacient, RU 486, into the U.S. should not be simplistically characterized as the FDA’s failure to admit a promising new drug for ... -
Tort Liability and Vaccine Manufacturers
(1994)This paper has been written with future vaccines in mind. It is true, of course, that most vaccines currently available are extremely safe and not prohibitively expensive. For the few injuries caused by these vaccines, an ... -
TIGHTENING THE BELT ON THE WEIGHT-LOSS INDUSTRY
(1994)Americans dole out $33 billion dollars a year to cure their weight problems, as every year the market is flooded with food and drug products that promise a fast, easy way to a new, slimmer you. Unfortunately, while there ... -
FDA Regulation of Quack Devices: It's a Miracle!...or Is It?
(1994)Medical devices that presented substantial deception or an unreasonable and substantial risk of illness or injury have existed since the inception of this country. Even our forefathers such as Ben Franklin were subjected ... -
PROVIDING INCENTIVES TO INDUSTRY TO DEVELOP NEW CONTRACEPTIVES
(1995)This paper will discuss why this lack of contraceptive alternatives poses such a tremendous problem, and will describe the birth control options currently available. Additionally, the paper will describe the four main ... -
REFORMING DRUG APPROVAL IN THE UNITED STATES: MEASURES NECESSARY TO ALLEVIATE THE CASH CRUNCH FACED BY SMALL BIOTECHNOLOGY COMPANIES
(1995)Over the past decade, the infant biotechnology industry, led by small biotechnology companies, has produced numerous breakthrough drugs which have saved lives, reduced suffering and cut the cost of health care. Given that ... -
Use of Blending as a Method to Bring Filth Content Within Defect Action Levels: An Idea Whose Time Has Come?
(1995)This paper begins with a brief discussion, for illustrative purposes, of the evolution of regulations for reconditioning in the food salvage industry, and present requirements for reconditioning adulterated food. It then ...