Compassionate Use And Emergency Use Authorization For Unapproved Drugs

Download Compassionate Use And Emergency Use Authorization For Unapproved Drugs full books in PDF, epub, and Kindle. Read online Compassionate Use And Emergency Use Authorization For Unapproved Drugs ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Compassionate Use and Emergency Use Authorization for Unapproved Drugs

Author : Tonya Burke
Publisher :
ISBN 13 : 9781634841405
Total Pages : 113 pages
Book Rating : 4.8/5 (414 download)

DOWNLOAD NOW!

Book Synopsis Compassionate Use and Emergency Use Authorization for Unapproved Drugs by : Tonya Burke

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.

Access to Unapproved Drugs

Author : Thaul Susan
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (15 download)

DOWNLOAD NOW!

Book Synopsis Access to Unapproved Drugs by : Thaul Susan

Download or read book Access to Unapproved Drugs written by Thaul Susan and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This report discuses the approval or licensure procedures of drugs and biological products which Food and Drug Administration (FDA) may permit the sponsor to provide an unapproved or unlicensed product to patients outside the standard regulatory framework.

Guidance

Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (32 download)

DOWNLOAD NOW!

Book Synopsis Guidance by :

Download or read book Guidance written by and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance explains FDA's policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act (FD & C Act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Public Law 108-276).2 Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The Emergency Use Authorization (EUA) authority recently granted by Congress allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives. The document is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of EUAs.3 FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD)) or private entities. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met.

Nightmare Scenario

Author : Yasmeen Abutaleb
Publisher : HarperCollins
ISBN 13 : 0063066076
Total Pages : 496 pages
Book Rating : 4.0/5 (63 download)

DOWNLOAD NOW!

Book Synopsis Nightmare Scenario by : Yasmeen Abutaleb

Download or read book Nightmare Scenario written by Yasmeen Abutaleb and published by HarperCollins. This book was released on 2021-06-29 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.

Guidance for Managing Ethical Issues in Infectious Disease Outbreaks

Author : World Health Organization
Publisher :
ISBN 13 : 9789241549837
Total Pages : 0 pages
Book Rating : 4.5/5 (498 download)

DOWNLOAD NOW!

Book Synopsis Guidance for Managing Ethical Issues in Infectious Disease Outbreaks by : World Health Organization

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.

Guidelines for the Programmatic Management of Drug-resistant Tuberculosis

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241547588
Total Pages : 271 pages
Book Rating : 4.2/5 (415 download)

DOWNLOAD NOW!

Book Synopsis Guidelines for the Programmatic Management of Drug-resistant Tuberculosis by : World Health Organization

Download or read book Guidelines for the Programmatic Management of Drug-resistant Tuberculosis written by World Health Organization and published by World Health Organization. This book was released on 2008 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emergence of extensively drug-resistant strains of tuberculosis, especially in countries with a high prevalence of human immunodeficiency virus, is a serious threat to global public health and jeopardizes efforts to effectively control the disease. This publication offers updated recommendations for the diagnosis and management of drug-resistant tuberculosis in a variety of geographical, economic and social settings, and the recording of data that enables the monitoring and evaluation of programs.--Publisher's description.

Addressing the Barriers to Pediatric Drug Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309178657
Total Pages : 64 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis Addressing the Barriers to Pediatric Drug Development by : Institute of Medicine

Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

A National Cancer Clinical Trials System for the 21st Century

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157870
Total Pages : 317 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis A National Cancer Clinical Trials System for the 21st Century by : Institute of Medicine

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.

Bacteriophages

Author : David R. Harper
Publisher : Springer Nature
ISBN 13 : 3319419862
Total Pages : 1376 pages
Book Rating : 4.3/5 (194 download)

DOWNLOAD NOW!

Book Synopsis Bacteriophages by : David R. Harper

Download or read book Bacteriophages written by David R. Harper and published by Springer Nature. This book was released on 2021-01-30 with total page 1376 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first major reference work dedicated to the mannifold industrial and medical applications of bacteriophages provides both theoretical and practical insights into the emerging field of bacteriophage biotechnology. The book introduces to bacteriophage biology, ecology and history and reviews the latest technologies and tools in bacteriophage detection, strain optimization and nanotechnology. Usage of bacteriophages in food safety, agriculture, and different therapeutic areas is discussed in detail. This book serves as essential guide for researchers in applied microbiology, biotechnology and medicine coming from both academia and industry.

Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine

Author : National Academies Of Sciences Engineeri
Publisher : National Academies Press
ISBN 13 : 9780309269452
Total Pages : pages
Book Rating : 4.2/5 (694 download)

DOWNLOAD NOW!

Book Synopsis Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine by : National Academies Of Sciences Engineeri

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.

Practical Aspects of Signal Detection in Pharmacovigilance

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
ISBN 13 : 9789290360827
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

DOWNLOAD NOW!

Book Synopsis Practical Aspects of Signal Detection in Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)

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.

A Clinical Trials Manual From The Duke Clinical Research Institute

Author : Margaret Liu
Publisher : John Wiley & Sons
ISBN 13 : 1444357883
Total Pages : 381 pages
Book Rating : 4.4/5 (443 download)

DOWNLOAD NOW!

Book Synopsis A Clinical Trials Manual From The Duke Clinical Research Institute by : Margaret Liu

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.

Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials

Author : World Health Organization
Publisher : WHO
ISBN 13 : 9789290360803
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

DOWNLOAD NOW!

Book Synopsis Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials by : World Health Organization

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.

International Ethical Guidelines for Health-Related Research Involving Humans

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

DOWNLOAD NOW!

Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

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.

The Stigma of Addiction

Author : Jonathan D. Avery
Publisher : Springer
ISBN 13 : 3030025802
Total Pages : 226 pages
Book Rating : 4.0/5 (3 download)

DOWNLOAD NOW!

Book Synopsis The Stigma of Addiction by : Jonathan D. Avery

Download or read book The Stigma of Addiction written by Jonathan D. Avery and published by Springer. This book was released on 2019-01-09 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the stigma of addiction and discusses ways to improve negative attitudes for better health outcomes. Written by experts in the field of addiction, the text takes a reader-friendly approach to the essentials of addiction stigma across settings and demographics. The authors reveal the challenges patients face in the spaces that should be the safest, including the home, the workplace, the justice system, and even the clinical community. The text aims to deliver tools to professionals who work with individuals with substance use disorders and lay persons seeking to combat stigma and promote recovery. The Stigma of Addiction is an excellent resource for psychiatrists, addiction medicine specialists, students across specialties, researchers, public health officials, and individuals with substance use disorders and their families.

Emergency Medical Services for Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309048885
Total Pages : 415 pages
Book Rating : 4.3/5 (9 download)

DOWNLOAD NOW!

Book Synopsis Emergency Medical Services for Children by : Institute of Medicine

Download or read book Emergency Medical Services for Children written by Institute of Medicine and published by National Academies Press. This book was released on 1993-02-01 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can we meet the special needs of children for emergency medical services (EMS) when today's EMS systems are often unprepared for the challenge? This comprehensive overview of EMS for children (EMS-C) provides an answer by presenting a vision for tomorrow's EMS-C system and practical recommendations for attaining it. Drawing on many studies and examples, the volume explores why emergency care for childrenâ€"from infants through adolescentsâ€"must differ from that for adults and describes what seriously ill or injured children generally experience in today's EMS systems. The book points the way to integrating EMS-C into current emergency programs and into broader aspects of health care for children. It gives recommendations for ensuring access to emergency care through the 9-1-1 system; training health professionals, from paramedics to physicians; educating the public; providing proper equipment, protocols, and referral systems; improving communications among EMS-C providers; enhancing data resources and expanding research efforts; and stimulating and supporting leadership in EMS-C at the federal and state levels. For those already deeply involved in EMS efforts, this volume is a convenient, up-to-date, and comprehensive source of information and ideas. More importantly, for anyone interested in improving the emergency services available to childrenâ€"emergency care professionals from emergency medical technicians to nurses to physicians, hospital and EMS administrators, public officials, health educators, children's advocacy groups, concerned parents and other responsible adultsâ€"this timely volume provides a realistic plan for action to link EMS-C system components into a workable structure that will better serve all of the nation's children.

Families Caring for an Aging America

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309448093
Total Pages : 367 pages
Book Rating : 4.3/5 (94 download)

DOWNLOAD NOW!

Book Synopsis Families Caring for an Aging America by : National Academies of Sciences, Engineering, and Medicine

Download or read book Families Caring for an Aging America written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-08 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Family caregiving affects millions of Americans every day, in all walks of life. At least 17.7 million individuals in the United States are caregivers of an older adult with a health or functional limitation. The nation's family caregivers provide the lion's share of long-term care for our older adult population. They are also central to older adults' access to and receipt of health care and community-based social services. Yet the need to recognize and support caregivers is among the least appreciated challenges facing the aging U.S. population. Families Caring for an Aging America examines the prevalence and nature of family caregiving of older adults and the available evidence on the effectiveness of programs, supports, and other interventions designed to support family caregivers. This report also assesses and recommends policies to address the needs of family caregivers and to minimize the barriers that they encounter in trying to meet the needs of older adults.