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Drug Safety And Drug Control

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Drug Safety And Drug Control

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Author : L. T. Coggeshall
language : en
Publisher:
Release Date : 1963

Drug Safety And Drug Control written by L. T. Coggeshall and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1963 with Drugs categories.

The Future Of Drug Safety

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-03-27

The Future Of Drug Safety written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-03-27 with Medical categories.

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

Drug Safety

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Author : United States. Congress. House. Committee on Government Operations
language : en
Publisher:
Release Date : 1964

Drug Safety written by United States. Congress. House. Committee on Government Operations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1964 with Drugs categories.

Challenges For The Fda

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-10-02

Challenges For The Fda written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-10-02 with Medical categories.

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.

Drug Safety

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Author : United States. Congress. House. Committee on Government Operations
language : en
Publisher:
Release Date : 1964

Drug Safety

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Author : Nigel S. B. Rawson
language : en
Publisher: FriesenPress
Release Date : 2016-11-08

Drug Safety written by Nigel S. B. Rawson and has been published by FriesenPress this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-08 with Drug categories.

With "Big Pharma" garnering an increasing number of negative headlines due to reports of adverse drug reactions and a surge in prescription drug addiction and overdose deaths, many people are increasingly skeptical about the safety of modern pharmaceutics and the moral integrity of the pharmaceutical industry. This book was written to provide a balanced perspective on drug safety risks. No therapeutic prescription drug is entirely risk-free. Before receiving marketing approval, new drugs go through arduous and expensive testing processes that can take up to a decade and cost over two billion dollars. While not perfect, the process is far from a "Wild West" environment where big pharmaceutical companies ride roughshod over government regulators. However, author and pharmacoepidemiologist Nigel Rawson argues, the antipathy that is common between governments, pharmaceutical industry and academic experts in Canada needs to change to an environment of collaboration and partnership to enhance our ability to respond in a timely fashion to future pharmaceutical crises. While directed mainly at students in the health sciences and pharmaceutical professionals, this book will be of interest to anyone, including lay people and policy makers, who would like to know more about the evolution of the prescription drug evaluation and risk assessment process. Although the book focuses primarily on Canada, it makes comparisons with the United States and Europe, and several of the author's recommendations for how to improve the prescription drug evaluation process are applicable worldwide.

Cancer Drug Safety And Public Health Policy

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Author : Charles Bennett
language : en
Publisher: Springer Nature
Release Date : 2022-11-30

Cancer Drug Safety And Public Health Policy written by Charles Bennett and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-30 with Medical categories.

This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.

Quantitative Evaluation Of Safety In Drug Development

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Author : Qi Jiang
language : en
Publisher: CRC Press
Release Date : 2014-12-08

Quantitative Evaluation Of Safety In Drug Development written by Qi Jiang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-08 with Mathematics categories.

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Drug Safety

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Author : United States. Congress. House. Committee on Government Operations
language : en
Publisher:
Release Date : 1964

Hearings held Mar. 9, 10, May 25, 26, June 7-9, 1966--pt.5.

Children And Drug Safety

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Author : Cynthia A Connolly
language : en
Publisher: Rutgers University Press
Release Date : 2018-05-11

Children And Drug Safety written by Cynthia A Connolly and has been published by Rutgers University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-11 with Health & Fitness categories.

Winner of the 2018 Arthur J. Viseltear Award from the Medical Care Section of the American Public Health Association Children and Drug Safety traces the development, use, and marketing of drugs for children in the twentieth century, a history that sits at the interface of the state, business, health care providers, parents, and children. This book illuminates the historical dimension of a clinical and policy issue with great contemporary significance—many of the drugs administered to children today have never been tested for safety and efficacy in the pediatric population. Each chapter of Children and Drug Safety engages with major turning points in pediatric drug development; themes of children’s risk, rights, protection and the evolving context of childhood; child-rearing; and family life in ways freighted with nuances of race, class, and gender. Cynthia A. Connolly charts the numerous attempts by Congress, the Food and Drug Administration, the American Academy of Pediatrics, and leading pediatric pharmacologists, scientists, clinicians, and parents to address a situation that all found untenable. Open access edition funded by the National Endowment for the Humanities. The text of this book is licensed under a Creative Commons Attribution NonCommercial-NoDerivatives 4.0 International License: https://creativecommons.org/licenses/by-nc-nd/4.0/

Drug Safety And Drug Control

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