Download or read book Compassionate Use and Emergency Use Authorization for Unapproved Drugs written by Tonya Burke and published by . This book was released on 2015 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and emergency use authorization. This book examines FDA policies on compassionate use and emergency use authorizations. It also describes how drugs are approved and come to market, including FDA's role in that process, and discusses FDA and industry roles once drugs are on the pharmacy shelves. Finally, this book describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary; presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children, and provides an overall understanding of FDA's authority to ensure that drugs prescribed to children are safe and effective.
Download or read book Nightmare Scenario written by Yasmeen Abutaleb and published by HarperCollins. This book was released on 2022-07-05 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Instant #1 New York Times and Wall Street Journal bestseller From the Washington Post journalists Yasmeen Abutaleb and Damian Paletta—the definitive account of the Trump administration’s tragic mismanagement of the COVID-19 pandemic, and the chaos, incompetence, and craven politicization that has led to more than a half million American deaths and counting. Since the day Donald Trump was elected, his critics warned that an unexpected crisis would test the former reality-television host—and they predicted that the president would prove unable to meet the moment. In 2020, that crisis came to pass, with the outcomes more devastating and consequential than anyone dared to imagine. Nightmare Scenario is the complete story of Donald Trump’s handling—and mishandling—of the COVID-19 catastrophe, during the period of January 2020 up to Election Day that year. Yasmeen Abutaleb and Damian Paletta take us deep inside the White House, from the Situation Room to the Oval Office, to show how the members of the administration launched an all-out war against the health agencies, doctors, and scientific communities, all in their futile attempts to wish away the worst global pandemic in a century. From the initial discovery of this new coronavirus, President Trump refused to take responsibility, disputed the recommendations of his own pandemic task force, claimed the virus would “just disappear,” mocked advocates for safe-health practices, and encouraged his base and the entire GOP to ignore or rescind public health safety measures. Abutaleb and Paletta reveal the numerous times officials tried to dissuade Trump from following his worst impulses as he defied recommendations from the experts and even members of his own administration. And they show how the petty backstabbing and rivalries among cabinet members, staff, and aides created a toxic environment of blame, sycophancy, and political pressure that did profound damage to the public health institutions that Americans needed the most during this time. Even after an outbreak in the fall that swept through the White House and infected Trump himself, he remained defiant in his approach to the virus, very likely costing him his own reelection. Based on exhaustive reporting and hundreds of hours of interviews from inside the disaster zone at all levels of authority, Nightmare Scenario is a riveting account of how the United States government failed its people as never before, a tragedy whose devastating aftershocks will linger and be felt by generations to come.
Download or read book Guidance for Managing Ethical Issues in Infectious Disease Outbreaks written by World Health Organization and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Infectious disease outbreaks are frequently characterized by scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust. Policy makers and public health professionals may be forced to weigh and prioritize potentially competing ethical values in the face of severe time and resource constraints. This document seeks to assist policy-makers, health care providers, researchers, and others prepare for outbreak situations by anticipating and preparing for the critical ethical issues likely to arise."--Publisher.
Download or read book Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2022-07-20 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Strategy for Combating Antibiotic Resistant Bacteria, published in 2014, sets out a plan for government work to mitigate the emergence and spread of resistant bacteria. Direction on the implementation of this strategy is provided in five-year national action plans, the first covering 2015 to 2020, and the second covering 2020 to 2025. Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine evaluates progress made against the national strategy. This report discusses ways to improve detection of resistant infections and estimate the risk to human health from environmental sources of resistance. In addition, the report considers the effect of agricultural practices on human and animal health and animal welfare and ways these practices could be improved, and advises on key drugs and diseases for which animal-specific test breakpoints are needed.
Download or read book Pediatric Sedation Outside of the Operating Room written by Keira P. Mason and published by Springer. This book was released on 2014-10-11 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a major revision, updating, and expansion of the leading single-source volume on pediatric sedation outside of the operating room. Edited and written by an international roster of outstanding experts, it is the only book aimed at the broad range of specialists who deliver pediatric sedation in the non-OR setting. The Second Edition features a significant expansion of contributions from international leaders and individual new chapters on pre-sedation assessment; sedatives’ short- and long-term effects on neurocognition; non-pharmacologic distractions; Michael Jackson’s death and medical ethics; the role of simulation in safety and training; and palliative sedation in terminally ill children. The specialty-specific chapters continue to be geared toward all sedation providers, regardless of where they practice and patient safety is again emphasized. Fundamental chapters provide in-depth reviews of topics which include, among others, physiology and pharmacology. The book presents the latest guidelines across the specialties, both in the United States and abroad and noteworthy, ongoing research endeavors. From reviews of the First Edition: “This meritorious volume is a splendid collection of materials from highly experienced authors...I will make extensive use of this reference as the academic medical center in which I work continues to build sedation practices and assess credentialing/privileging aspects for professionals of all fields.” —Joseph R. Tobin, MD in Journal of the American Medical Association. “Brings together sedation practice from a broad range of specialties into one well-written pediatric text...I will certainly be using this book as a reference text in the future.” — Pediatric Anesthesia. “The first [text] directed at all specialists that treat children who require some sedation...also recognizes the contributions to pediatric sedation of many international societies and governmental organizations...It should be on the shelves of all office-based practices.” —Journal of Neurosurgical Anesthesiology. "With the ever-increasing opportunities to perform various investigations and therapeutic procedures, combined with increasing demands and expectations from children and their parents, the need and demand for safe and effective sedation of paediatric patients outside the operating room is increasing. Against this background, the second edition of ‘Pediatric Sedation Outside the Operating Room’ is a very timely addition to the anaesthesia literature."—British Journal of Anesthesia
Download or read book Marijuana and Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-10 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book A National Cancer Clinical Trials System for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2010-07-08 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
Download or read book Public Health 101 written by Riegelman and published by Jones & Bartlett Learning. This book was released on 2018-03-08 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: From clean drinking water, to seat belts, to immunizations, the impact of public health on every individual is undeniable. For undergraduates, an understanding of the foundations of public health is an essential step toward becoming an educated citizen. Public Health 101 provides a big-picture, population perspective on the determinants of health and disease and the tools available to protect and promote health. It examines the full range of options for intervention including use of the healthcare system, the public health system, and society-wide systems such as laws and taxation.
Download or read book TIP 35 Enhancing Motivation for Change in Substance Use Disorder Treatment Updated 2019 written by U.S. Department of Health and Human Services and published by Lulu.com. This book was released on 2019-11-19 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Motivation is key to substance use behavior change. Counselors can support clients' movement toward positive changes in their substance use by identifying and enhancing motivation that already exists. Motivational approaches are based on the principles of person-centered counseling. Counselors' use of empathy, not authority and power, is key to enhancing clients' motivation to change. Clients are experts in their own recovery from SUDs. Counselors should engage them in collaborative partnerships. Ambivalence about change is normal. Resistance to change is an expression of ambivalence about change, not a client trait or characteristic. Confrontational approaches increase client resistance and discord in the counseling relationship. Motivational approaches explore ambivalence in a nonjudgmental and compassionate way.
Download or read book Quality written by Kathleen E. McCormick and published by Butterworth-Heinemann. This book was released on 2022-07-14 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. Fully revised, updated, and expanded new edition Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools Includes end-of-chapter summaries and end-of-chapter question and/or problems Provides detailed steps and examples for applying the guidelines and quality tools Written in an accessible style making the content easy to understand and apply
Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Download or read book Development Safety Update Report DSUR Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials written by World Health Organization and published by WHO. This book was released on 2006 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regular and timely review appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Whereas the overall goal of a clinical development program is to characterize the benefit-risk relationship of the product in a particular patient population, the risk to individual trial subjects is a critical consideration during product development at a time when the effectiveness of a product is generally uncertain. By conducting an overall appraisal of safety data at regular intervals, risks can be recognized thoughtfully assessed and appropriately communicated to all interested stakeholders to support the safety of clinical trial subjects. Although regulatory authorities currently require the submission of a periodic safety report during the conduct of clinical trials, there are substantial differences in the format content and timing of the different reports. The CIOMS VII Working group is proposing in this new publication an internationally harmonized document namely the Development Safety Update Report (DSUR) that is modeled after the Periodic Safety Update Report (PSUR) for marketed products. It presents the general principles behind the preparation and use of the DSUR and a model DSUR. The model is illustrated with sample fictitious DSURs for a commercial and non-commercial (trial-specific) sponsor.
Download or read book Illinois 2021 Rules of the Road written by State of State of Illinois and published by . This book was released on 2021-07-19 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: Illinois 2021 Rules of the Road handbook, drive safe!
