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‣ The Regulation of Medical Computer Software as a “Device” under the Food, Drug, and Cosmetic Act

Brannigan, Vincent
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 26/10/1986 Português
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Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a “device” under the Food, Drug and Cosmetic Act. The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the statutory scheme, examine constitutional arguments relating to computer software, and discuss regulatory principles that should be taken into account when deciding appropriate regulation. This paper is limited to computer program output used by humans in deciding appropriate medical therapy for a patient.

‣ Establishing new principles for nutrient reference values (NRVs) for food labeling purposes

Yates, Allison A.
Fonte: The Korean Nutrition Society and The Korean Society of Community Nutrition Publicador: The Korean Nutrition Society and The Korean Society of Community Nutrition
Tipo: Artigo de Revista Científica
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Many countries such as The Republic of Korea have established their own nutritional standards, collectively termed Nutrient Reference Values(NRVs), and they vary due to the science which was reviewed, the purposes for which they are developed, and issues related to nutrition and food policy in the country. The current effort by the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) to update the NRVs that were established following the Helsinki Consultation in 1988 represents an opportunity to develop a set of reference values reflecting current scientific information to be used or adapted by many countries. This paper will focus on possible approaches to selecting or developing reference values which would serve the intended purpose for nutrition labeling to the greatest extent possible. Within the United States, the Food and Drug Administration (U.S. FDA) is currently reviewing regulations on nutrition labeling to better address current health issues, and is expected to enter into a process in the next few months to begin to explore how best to update nutrient Daily Values (DVs), most of which are still based on the Recommended Dietary Allowances (RDAs) of the Food and Nutrition Board, U.S. National Academy of Sciences...

‣ Federal Preemption of State Tort Suits under the Medical Device Amendments of 1976

Jijón, Alissa Danielle
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Historically, plaintiffs injured by allegedly defective medical devices were able to bring tort suits against manufacturers in state court. With the passage of the Medical Device Amendments of 1976 (“MDA”) – a federal law containing an express preemption clause – many wondered whether such lawsuits would still be viable. Courts, FDA, device manufacturers, and the public alike have struggled to understand the scope of federal preemption under the new regime. This paper documents that struggle, beginning with the passage of the MDA in 1976. It then focuses on the Supreme Court’s landmark ruling on the issue twenty years later in Medtronic v. Lohr. It discusses the evolution of MDA preemption doctrine in the post-Lohr decade, and then addresses the Court’s most recent word on the subject – Medtronic v. Riegel. The paper concludes with a description of the most current understanding of federal preemption under the MDA and implications for the future of the field.; relation of food, drug and cosmetic act to state laws>>>federal preemption

‣ THE FOOD AND DRUG ADMINISTRATION AND THE PROPOSED REGULATION OF CIGARETTES

Prabhu, Jayani V.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Since the 1930s the Food and Drug Administration ("FDA") has taken broad Jurisdiction over eveiyday products in an attempt to ensure public health. Despite that mission, the FDA In particular and the Federal government In general has done little to regulate the tobacco Industry. Recently, however, the Commissioner of the FDA, Dr. David A. Kessler. raised the possibility of regulating the cigarette industry. But is the simple regulation of cigarettes permitted by the Federal Food, Drug and Cosmetic Act of 1938, which grants the FDA jurisdiction over products? Given the unanimity of opinion on the hazards of cigarette smoking, the answer to this question is no, and yet the conclusion that cigarettes must be banned seems too radical to seriously imagine. As a result, the context in which the FDA has approached cigarette smoking should be analyzed.

‣ THE PERVASIVELY REGULATED BUSINESS EXCEPTION AND THE FDA

Wood, Valerie D.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Section 704 of the Federal Food, Drug and Cosmetic Act authorizes the Food and Drug Administration to conduct inspections of regulated business establishments. In the statute. Congress required that the inspections be at reasonable times and within reasonable limits and in a reasonable manner. Congress further restricted the inspections from including general financial and personnel data, and research data not relating to specially regulated drugs.

‣ An Examination of Strict Criminal Liability Under the Food, Drug and Cosmetic Act of 1938: Is It Time For Change?

Holt, Breena L.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Food and drug violations have been largely governed by a strict liability standard since the nineteenth century. Use of this standard in connection with criminal sanctions has generally been defended on the grounds that the health and welfare of the public are of such importance that it is necessary to provide members of the food and drug industry with an extra impetus to abide by the applicable food and drug regulations. Nonetheless, strict criminal liability has not been wholly successful in averting violations of food and drug regulations, as evidenced by the presence of a number of criminal cases involving food and drug industry participants. It, therefore, might be time to question the goals of the Food, Drug and Cosmetic Act of 1938, enforcement policy, and whether the use of strict criminal liability is a necessary method of achieving those goals in the current setting. This paper attempts to analyze these questions by tracing the history of strict liability in the area of food and drug law violations, discussing the common arguments in favor and against the imposition of strict liability in that context, and exploring alternative regimes given the current state of affairs.

‣ Researching and Regulating Prescription of Psychotropic Drugs in Adolescents

Claiborne, Anne B.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The Food and Drug Administration (FDA) occupies a prominent place in the pantheon of public health-oriented agencies of the United States government, seated within the Department of Health and Human Services and maintaining crucially tight regulatory control over, among many other things, the safety of our food supply and the safety and efficacy of our drug supply. Indeed, it is well established that the primary purpose of the Food, Drug, and Cosmetic Act of 1938 – FDAs enabling statute – is to “protect the public health.†This paper explores the current widespread prescription of psychotropic drugs in adolescents – and the comparatively low levels of existing and ongoing research investigating their safety, efficacy, and appropriateness – to question whether the policies and procedures that FDA promulgates and follows actually conform to the basic principles of “public health.â€

‣ A Retrospective Review of FDA v. Brown Williamson Tobacco Corporation and the Issue of Congressional Intent

Brooks, Angela
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Contrary to a tradition of the FDA (Federal Food and Drug Administration) consistently maintaining that it could not assert jurisdiction over tobacco products, the agency issued a determination of jurisdiction over cigarettes and smokeless tobacco and proposed a set of regulations in 1996 in an effort to combat the public health problems caused by tobacco products. Rather than a complete ban, the FDA proposed regulations aimed solely at younger Americans due to its conclusion that such an approach was safer for the public health. Despite a variety of arguments by the FDA, the Supreme Court held that the FDA could not assert jurisdiction over tobacco products because Congress had directly addressed that precise question and had precluded the FDA from regulating cigarettes and smokeless tobacco. Examining the FDA regulatory scheme as well as the several pieces of tobacco-specific legislation enacted by Congress, the Court found that the FDA’s regulation of tobacco products would be contradictory to the FDCA (Food, Drug, and Cosmetic Act) as a whole and to Congress’ intent to adopt a separate regulatory regime for tobacco products. Through a narrow interpretation of the FDCA and a broad reading of the tobacco-related legislation broadly...

‣ The Regulation of Tea and Its Health-Related Claims in the Wake of Developing Scientific Evidence: Food, Drug, or Dietary Supplement?

Pirina, Jean C.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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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 Administration to insure that consumers are well protected. The health claims of tea must be evaluated and screened to avoid consumer fraud. To accomplish this, regulators must first determine what category tea falls under for purposes of the Food, Drug and Cosmetic Act. Unfortunately, this is no easy task given the wide array of potential uses for tea. Therefore, in a modern society where the Internet supplies much of consumers’ information, lawmakers and regulators will have to adopt a regulatory scheme that is equipped to handle a diverse and emerging product.

‣ Scientology and the FDA: A Look Back, A Modern Analysis, And A New Approach

Cavanaugh, Jeanne
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Clashes between the government’s power to regulate activity and religious adherents’ free exercise right to practice their religion are frequent. However, for some federal agencies, such as the Food and Drug Administration (FDA), conflicts with religion are not commonplace and, when they do occur, are arduous and complicated. This paper seeks to explore the historical legal battle between the FDA and the Church of Scientology (Scientology), an off-beat religious movement that employs a device known as an E-meter in its activities. Scientology alleges that the E-meter has therapeutic and curative properties. The paper examines the conflict from three perspectives. First, it provides a narrative account of the conflict between Scientology and the FDA as well as an analysis of three significant legal cases that arose during the conflict. Second, it examines how both constitutional law and the Federal, Food, Drug and Cosmetic Act (FDCA) have evolved since the clash between the FDA and Scientology and how these changes in the law would alter the judicial analysis if the Scientology cases were tried in the courts today. Finally, this paper suggests an amendment to the FDCA that, if adopted and applied to a religious device similar to that of the E-meter...

‣ Self-Regulation in the Cosmetic Industry: A Necessary Reality or a Cosmetic Illusion?

Daum, Casey
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The 1938 Food, Drug, and Cosmetic Act brought the cosmetic industry under the regulatory jurisdiction of the FDA. However, the confluence of federal administrative budgetary constraints, historical conditions of the cosmetic industry’s development, and pragmatic policy considerations has fostered a unique regulatory regime. The FDA has come to rely heavily on the cosmetic industry to regulate itself in order to ensure consumer safety. Recent criticisms allege that this system of self-regulation is ineffective, inefficient, and/or inappropriate. This paper will situate these criticisms within their various contexts – the historical, social, and administrative realities which define and constrain potential regulatory approaches – in order to assess the propriety of the current schema of cosmetic industry self-regulation.

‣ Blame Canada?: State Prescription Drug Importation Programs, the Federal Response, and Why Lawmakers Are Up in Arms

Fishman, Janna K.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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A growing war on drugs threatens to turn septuagenarians into scofflaws and state governors into full-fledged lawbreakers. As American citizens—especially the powerful elderly constituency—grow increasingly vocal about the high prices of prescription drugs in the United States, many state and local leaders have taken decisive action to lower prices. State governors and city mayors across the nation have implemented programs that allow participants to buy prescription drugs at reduced prices from Canada and other countries. Although these programs clearly violate provisions of the Food, Drug and Cosmetic Act, the federal government has not taken decisive legal action against the states, instead preferring to focus its enforcement energy on private wholesalers who import drugs illegally for sale in the United States. Meanwhile, these state programs continue to operate with no serious federal resistance. Inside the Beltway, various Senators and Congressmen have taken up the call to arms, sponsoring bills aimed at legalizing drug importation. While several of these crucial bills have been held up, stalled or otherwise delayed, drug importation opponents have publicly questioned whether wholesale legalization of drug importation would truly best serve the American public...

‣ "Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

Goldstein, Beth F.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, and Cosmetic Act (hereinafter, Act), the FDA monitors the manufacturing practices of companies involved in the production of food, drugs, and medical devices. The manufacturing practices used by these companies must comply with certain standards, identified in the Act as "current good manufacturing practices" (hereinafter, CGMP). If a company's practices do not conform with CGMPs, the finished products are considered adulterated, even if the products are technically perfect. The purpose of CGMPs is to assure the safety and efficacy of the finished products.

‣ THE PRICE WE PAY: The Efficacy Requirement for New Drugs Under the Food, Drug and Cosmetic Act

Rubenstein, Corey B.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The newly sworn Republican-controlled Congress has, as one of its primary objectives, the downsizing of government. Speaker Newt Gingrich has specifically targeted the federal Food and Drug Administration (FDA) for the conservative wrath. The political climate that led to the change in power in Congress is partly based on the nation's anti-regulatory demeanor -- the belief, whether correct or mistaken, that the regulators have run riot, that there is too much power in the hands of a few appointed bureaucrats. The FDA draws specific attention because of the palpable effects of its rulings in the lives of all citizens. Specifically, the requirements for the pre-market approval of new drugs have been criticized for being too cumbersome. This paper will attempt to draw a compromise between the observed problem of overregulation in that area and the still important policies underlying the federal Food, Drug, and Cosmetic Act (FDCA). It will call for the elimination of the efficacy requirement for new drug applications (NDA) as a way to reduce the costs of developing new drugs, while maintaining the safely requirement in order to ensure the public health.

‣ FDA Regulation and the New Anti-aging Products

Hensel, Donald P.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In the decades since the enactment of the Federal Food, Drug, and Cosmetic Act (the "Act")' in 1938, one of the more persistent challenges facing the Food and Drug Administration (the "FDA") has been to apply an old statute to the regulatory problems generated by new technologies. The development of new anti-aging skin preparations is a recent example of this phenomenon. Although potions purporting to make the skin younger have existed for centuries, today's youth-seekers are spending billions on new products that just might work. In particular, the development of alpha hydroxy acids ("AHAs") has been promising. Derived from fruit, sugar cane, and milk, AHAs cause the surface layer of dead skin cells to shed, hastening the appearance of fresh cells. The laboratory results are inconclusive thus far, but preliminary research shows that some products may deliver active ingredients to the skin's inner layer, stimulating the production of moisturizing acids and cells such as collagen that help to keep the skin firm.

‣ FOOD, DRUGS, AND THE ENVIRONMENT: HOW THE FOOD AND DRUG ADMINISTRATION HAS INTERACTED WITH THE NATIONAL ENVIRONMENTAL POLICY ACT OF 1969

Liftik, Michael
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The paper proceeds in three parts. Part II provides an overview of NEPA. The section examines the statutory text and foundational case law to understand how the statute operates and the obligations it imposes on agencies. The section also examines the legislative history of the statute to determine to what extent, if any, Congress directly addressed the issue of how food safety or human health could impact the environment. Part III examines the FDA and the statutes it administers, the Food, Drug, and Cosmetic Act (FDCA). The purpose of the section is to outline the scope of the agency's jurisdiction and highlight those areas of jurisdiction where decision making could affect the environment. In Part IV, the paper takes a largely historical approach to analyze how the FDA and NEPA have interacted. In six major episodes, or 'rounds,' the FDA has confronted its obligations under NEPA. There are two categories of episodes: those in which the FDA has taken steps, some more grudging than others, to comply with NEPA and those in which NEPA could have played a more extensive role in FDA decision making to identify or avoid environmental harm. Several of these six rounds have been independently addressed by academic literature. This paper does not attempt to replicate the scope or detail of those efforts. The principal intent of this paper is to compile all these episodes in one place -- to examine the FDA's interaction with NEPA holistically and to observe change in attitudes and strategies through time.

‣ PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs

Corrigan, Kerry A.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In 1938 the Food and Drug Administration (FDA) adopted regulations which created a category of prescription drugs to be distributed only by order of a physician or other licensed medical personnel. This categorization, along with the extensive regulation of the approval, labelling and marketing of human drugs, has substantially reduced the risks which accompanied self-medication. However, the current regulatory regime does not place any limits on physician prescribing. This shortfall in regulation fails to protect patients from poor prescribing practices and exposes these patients to otherwise preventable adverse drug reactions (ADRs). Attempts to remedy this shortfall have been unsuccessful. Under the existing Food, Drug and Cosmetic Act (FD&C Act) and its judicial interpretation in An~rican Pharmaceutical Ass 'n v. Weinberge , the FDA seemingly does not have the authority to regulate physician prescribing practices.

‣ Criminal Liability Under the Food, Drug, and Cosmetic Act

Blume, Michael S.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The criminal provisions of the Federal Food, Drug, and Cosmetic Act (FDCA)' and the judicial interpretation thereof afford the Food and Drug Administration (FDA) great discretion, in determining both when and against whom criminal prosecution is warranted. Though it may employ a wide variety of enforcement mechanisms, the FDA has relied in recent years ever more heavily on criminal proceedings. Absent appropriate guidelines, however, extensive use of criminal sanctions to enforce the FDCA potentially leads to costly, inefficient, and unnecessary prosecutions. This paper attempts to define such guidelines in the context of criminal liability for corporate officers and employees. First, the paper will describe corporate liability under the FDCA. Next, it will utilize economic tools to propose guidelines to help determine when this liability is best imposed. Finally, it will examine the factual settings of two seminal cases in food and drug law using the proposed guidelines.

‣ The Regulation of Medical Software under the Food, Drug and Cosmetic Act: A Perspective from the Government

Schneider, R.H.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 26/10/1986 Português
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FDA is currently developing a policy regarding application of the Food, Drug and Cosmetic Act in the medical software marketplace. It should be available for review in draft form in summer or early fall 1986. This paper reviews the Agency's device regulation program and its implications for any medical software products deemed to be medical devices under that policy. It is anticipated that implementation will proceed smoothly, without undue delay or expense to industry or government.

‣ First Amendment Scrutiny of FDA'S Fight Against Misbranding: Placing Labeling on the Spectrum of Speech

Weissman, Kenneth I.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In order to further the Food and Drug Administration's (FDA) mission of "assur[ing] that the products it regulates are safe and truthfully labeled," the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the power to enforce prohibitions on labeling that causes a food, drug, cosmetic, or medical device to be misbranded. The FD&C Act defines labeling as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." Because of the expansive nature of this definition, independently written pamphlets, newspapers, and books that accompany products covered by the FD&C Act constitute labeling in certain circumstances. This exacerbates the tension between the First Amendment's free speech guarantee and FDA's mandate, and raises the question of how courts should scrutinize FDA's ability to seize or enjoin the sale of misleading labeling. The importance of both the Free Speech Clause and the protection of consumers makes this a difficult issue to resolve, and as of yet, "no case has squarely confronted the issue."