Download or read book New Trends in Drug Liability and Litigation written by and published by . This book was released on 1977 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prepared for distribution at the New trends in Drug Liability and Litigation Workshop, December 1977-January 1978.
Download or read book Pharmaceutical R D written by and published by DIANE Publishing. This book was released on 1993 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-01-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Download or read book Civil Liability in Criminal Justice written by Darrell L. Ross and published by Routledge. This book was released on 2014-09-19 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding case law in high-liability areas and performing the job within a legal framework places a criminal justice agency in the best position to defend against a lawsuit. This handbook addresses the problems confronting criminal justice practitioners and their agencies due to the ever-increasing number of civil liability lawsuits. It introduces the reader to civil liability generally and the federal law specifically, while indicating the steps that can be taken to minimize the risk of litigation. Civil Liability in Criminal Justice is one of very few texts on the subject that combines applicable case law and related liability research, a valuable feature for current and future policy makers and managers. Ross also provides an overview of current case law in high-liability areas, enhancing student knowledge and practitioner job performance.
Download or read book Integrating Substance Abuse Treatment and Vocational Services written by Nancy K. Young and published by . This book was released on 2006 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Download or read book Regulation Versus Litigation written by Daniel P. Kessler and published by University of Chicago Press. This book was released on 2011-02 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: The efficacy of various political institutions is the subject of intense debate between proponents of broad legislative standards enforced through litigation and those who prefer regulation by administrative agencies. This book explores the trade-offs between litigation and regulation, the circumstances in which one approach may outperform the other, and the principles that affect the choice between addressing particular economic activities with one system or the other. Combining theoretical analysis with empirical investigation in a range of industries, including public health, financial markets, medical care, and workplace safety, Regulation versus Litigation sheds light on the costs and benefits of two important instruments of economic policy.
Download or read book Promotion of Pharmaceuticals written by Julie A Fisher and published by CRC Press. This book was released on 1993-05-06 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: This important book evaluates trends in pharmaceutical advertising and promotion and addresses many of the perplexing questions involved in assessing drug promotion in our society. It examines legal and ethical issues surrounding pharmaceutical promotions and the benefits of pharmaceutical advertising and promotion and discusses the effectiveness of industry self-regulation and the potential for further legislative or regulatory response. Promotion of Pharmaceuticals offers a framework for understanding the informational effects of pharmaceutical promotion programs from a marketing and economic perspective. It also raises questions regarding pharmaceutical information at the macro level, including: Is pharmaceutical promotion excessive? Are further regulations needed to control the proliferation of misleading messages and to restrict the explicit and implicit persuasive powers of pharmaceutical promotion? What are the implications for the public?s health and social welfare of strict interpretation of the laws regarding dissemination of information on pharmaceuticals?Promotion of Pharmaceuticals suggests a cooperative, not adversarial, relationship between the FDA and the pharmaceutical industry to commit our limited health care resources to facilitating the provision of rational pharmaceutical care. It contains vital information for everyone who wants to make better informed decisions in the complex world of pharmaceuticals. Chapters discuss such relevant topics as regulatory issues for pre- and post-approved drugs, ethical considerations in drug advertising, and FDA and FTC concerns. Promotion of Pharmaceuticals answers questions such as Is pharmaceutical promotion interfering with the doctor-patient relationship? Can good business and good medicine go hand-in-hand? Is the cost of promotion increasing prescription drug prices to an unacceptable level? Other topics include an historical perspective on pharmaceutical advertising and viewpoints from the pharmaceutical leadership. This book is designed for individuals involved in advertising and promotion in the pharmaceutical industry, health care practitioners, consumer advocates, regulators and public policy decision-makers, and other persons involved in the delivery and consumption of pharmaceutical care.
Download or read book Product Liability and the Business Sector written by Terence Dungworth and published by . This book was released on with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug and Medical Device Product Liability Deskbook written by James Beck and published by Law Journal Press. This book was released on 2004 with total page 982 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Download or read book Autonomous Driving written by Markus Maurer and published by Springer. This book was released on 2016-05-21 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book takes a look at fully automated, autonomous vehicles and discusses many open questions: How can autonomous vehicles be integrated into the current transportation system with diverse users and human drivers? Where do automated vehicles fall under current legal frameworks? What risks are associated with automation and how will society respond to these risks? How will the marketplace react to automated vehicles and what changes may be necessary for companies? Experts from Germany and the United States define key societal, engineering, and mobility issues related to the automation of vehicles. They discuss the decisions programmers of automated vehicles must make to enable vehicles to perceive their environment, interact with other road users, and choose actions that may have ethical consequences. The authors further identify expectations and concerns that will form the basis for individual and societal acceptance of autonomous driving. While the safety benefits of such vehicles are tremendous, the authors demonstrate that these benefits will only be achieved if vehicles have an appropriate safety concept at the heart of their design. Realizing the potential of automated vehicles to reorganize traffic and transform mobility of people and goods requires similar care in the design of vehicles and networks. By covering all of these topics, the book aims to provide a current, comprehensive, and scientifically sound treatment of the emerging field of “autonomous driving".
Download or read book Orphans and Incentives written by Institute of Medicine and published by National Academies Press. This book was released on 1997-10-30 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues.
Download or read book Treating Drug Problems written by Committee for the Substance Abuse Coverage Study and published by National Academies Press. This book was released on 1992-01-01 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Treating Drug Problems, Volume 2 presents a wealth of incisive and accessible information on the issue of drug abuse and treatment in America. Several papers lay bare the relationship between drug treatment and other aspects of drug policy, including a powerful overview of twentieth century narcotics use in America and a unique account of how the federal government has built and managed the drug treatment system from the 1960s to the present. Two papers focus on the criminal justice system. The remaining papers focus on Employer policies and practices toward illegal drugs. Patterns and cycles of cocaine use in subcultures and the popular culture. Drug treatment from a marketing, supply-and-demand perspective, including an analysis of policy options. Treating Drug Problems, Volume 2 provides important information to policy makers and administrators, drug treatment specialists, and researchers.
