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Suing the tobacco and lead pigment industries
In Suing the Tobacco and Lead Pigment Industries, legal scholar Donald G. Gifford recounts the transformation of tort litigation in response to the challenge posed by victims of 21st-century public health crises who seek compensation from the product manufacturers. Class action litigation promised a strategy for documenting collective harm, but an increasingly conservative judicial and political climate limited this strategy. Then, in 1995, Mississippi attorney general Mike Moore initiated a parens patriae action on behalf of the state against cigarette manufacturers. Forty-five other states soon filed public product liability actions, seeking both compensation for the funds spent on public health crises and the regulation of harmful products. Gifford finds that courts, through their refusal to expand traditional tort claims, have resisted litigation as a solution to product-caused public health problems. Even if the government were to prevail, the remedy in such litigation is unlikely to be effective. Gifford warns, furthermore, that by shifting the powers to regulate products and to remediate public health problems from the legislature to the state attorney general, parens patriae litigation raises concerns about the appropriate allocation of powers among the branches of government.
eBook
Better safe than sorry : how consumers navigate exposure to everyday toxics
\"How toxic are the products we consume on a daily basis? Whether it's triclosan in toothpaste, formaldehyde in baby shampoo, endocrine disruptors in water bottles, or pesticides on strawberries, consumers are increasingly concerned about the chemicals in their food and personal care products. This book chronicles how ordinary people try to avoid exposure to toxics in grocery store aisles using the practice of 'precautionary consumption.' Through an innovative analysis of environmental regulation, the advocacy work of environmental health groups, the expansion of the health-food chain Whole Foods Market, and interviews with consumers, Norah MacKendrick ponders why the problem of toxics in the U.S. retail landscape has been left to individual shoppers--and to mothers in particular. She reveals how precautionary consumption, or 'green shopping,' is a costly and time-intensive practice, one that is connected to cultural ideas of femininity and good motherhood but is also most available to upper- and middle-class households. Better Safe Than Sorry powerfully argues that precautionary consumption places a heavy and unfair burden of labor on women and does little to advance environmental justice or mitigate risk.\"--Provided by publisher.
Book
Reputation and power
The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power?Reputation and Powertraces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.
Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.
Reputation and Powerdemonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.
eBook
No more tears : the secret history of Johnson & Johnson
\"When reporter Gardiner Harris met a woman at an airport bar whose entire family has been shattered by her nephew's use of the drug Risperdal, one she sold to his doctor as a drug sales rep, he began to wonder how many similar stories are out there. This was in 2004, and since then, Harris has been investigating one of the largest players in Big Pharma, continuously reporting on it despite simultaneous landmark journalistic accomplishments, like exposing the extremely toxic mining conditions ignored by coal companies. For decades, pharmaceutical giant Johnson & Johnson was seen as a paragon of ethical conduct, especially considering the company's child-friendly products like baby powder and tearless shampoo. However, Harris has uncovered reams of evidence of deceitful and dangerous corporate practices that reveal a historic threat to the health of the American public. He covers several disasters: tissue death caused by J & J's touted hip replacements, their coverup of baby powder's linkage to cancer, the teen-directed marketing of the life-altering drug Risperdal, and more. The Hatch-Waxman Bill, which is meant to pave the way for lower-priced generic drugs, passed in 1984, and inadvertently created loopholes in the drug approval process which allowed urgency and profit maximization to take precedence over diligence and patient protection. Johnson & Johnson's subsequent lack of oversight, money-grubbing, and flat out lies have resulted in the death or serious injury of millions of people. To many, the peril of falsified science seems distant, but Harris reveals how a combination of misrepresented data and bribe culture directly impact doctors' decisions-which are devastatingly revealed to be not at all in the interests of patients\"-- Provided by publisher.
BOOK
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
eBook
Medical Devices and the Public's Health
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market.
At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
eBook
Cost-Contained Regulatory Compliance
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Publication
A Review of Liposomes as a Drug Delivery System: Current Status of Approved Products, Regulatory Environments, and Future Perspectives
Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and lower toxic side effects. Given these merits, several liposomal drug products have been successfully approved and used in clinics over the last couple of decades. In this review, the liposomal drug products approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are discussed. Based on the published approval package in the FDA and European public assessment report (EPAR) in EMA, the critical chemistry information and mature pharmaceutical technologies applied in the marketed liposomal products, including the lipid excipient, manufacturing methods, nanosizing technique, drug loading methods, as well as critical quality attributions (CQAs) of products, are introduced. Additionally, the current regulatory guidance and future perspectives related to liposomal products are summarized. This knowledge can be used for research and development of the liposomal drug candidates under various pipelines, including the laboratory bench, pilot plant, and commercial manufacturing.
Journal Article