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Food and Drug Law Commons™

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Articles 211 - 216 of 216

Full-Text Articles in Food and Drug Law

Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles Jan 1991

Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles

Cleveland State Law Review

It has been more than ten years since the Food and Drug Administration proposed regulations which would have required detailed patient information for all prescription drugs. The proposed regulations, intended to promote the safe and effective use of prescription drugs, would have required a manufacturer to supply non-technical, non-promotional information, referred to as patient package inserts, directly to the patient. This note will analyze the need for patient information in satisfying the tort objectives of informed consent and public safety. The note will then analyze the practical effect of the learned intermediary and informed consent doctrines upon the manufacturer's and …

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Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause Jan 1991

Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause

Journal of Law and Health

By a careful examination of the Accutane experience, both here and abroad, I will illustrate some of the shortcomings of the current American system of drug regulation. There are a number of ways in which this system fails to live up to the strict regulatory philosophy that it purports to follow; in particular, there are systematic inadequacies in the design of clinical trials, the official labeling received by drugs, and the manner in which adverse reaction reports are collected and assessed. Additionally, although the system often works well, there are natural limitations to a system of pre-approval testing; for some …

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The Department Of Consumers, W. E. Forte Oct 1967

The Department Of Consumers, W. E. Forte

Vanderbilt Law Review

In 1872, Congress began protecting the American consumer by enacting legislation to prevent mail fraud. From this modest beginning, the consumer protection activities of the federal government have proliferated until today there are at least 33 government agencies engaged in 296 consumer protection activities. In 1961, the estimated annual expenditures by the federal government for direct consumer protection activities totaled 272 million dollars and the number of full-time federal employees engaged in such activities was almost 22,000. Expenditures for consumer advancement, a broader concept, were estimated at 681 million dollars in 1961 and the number of full time federal employees …

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The Food And Drug Administration And The Economic Adulteration Of Foods, Wesley E. Forte Apr 1966

The Food And Drug Administration And The Economic Adulteration Of Foods, Wesley E. Forte

Indiana Law Journal

No abstract provided.

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Food Additives Law And Practice, Milton Oppenheim Jan 1959

Food Additives Law And Practice, Milton Oppenheim

Cleveland State Law Review

A decision of the United States Supreme Court on Dec. 15, 1958, interpreting the Federal Food Drug & Cosmetic Act, has focused attention on the use of coloring and other materials in foods, drugs and cosmetics. This requires a complex study of the effects of the various food additives, contaminants and chemicals upon the individual, whether intentionally added or accidently produced, in foods, drugs and cosmetics. Evaluation of the tremendous group of food additives can best be approached in the light of the benefits intended by the manufacturer or grower using them.

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Federal Food, Drug, And Cosmetic Act - 20 Years Of Health Protection, Irvin Kerlan Jan 1959

Federal Food, Drug, And Cosmetic Act - 20 Years Of Health Protection, Irvin Kerlan

Cleveland State Law Review

Twenty years of major public health protection have been provided since enactment of the Federal Food, Drug, and Cosmetic Act of 1938. The Food and Drug Administration, a constituent of the United States Department of Health, Education, and Welfare, enforces this Act and thereby carries out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions; drugs and therapeutic devices are safe and effective for their intended uses; cosmetics are safe and prepared from appropriate ingredients; and that all of these products are honestly and informatively labeled and packaged. Man and animals …

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