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Ensuring Safe Medicines And Medical Devices For Children
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Book Synopsis Ensuring Safe Medicines and Medical Devices for Children by : United States Senate
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States Senate and published by . This book was released on 2019-09-08 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring safe medicines and medical devices for children: hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007.
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :64 pages Book Rating :4.0/5 ( download)
Book Synopsis Ensuring Safe Medicines and Medical Devices for Children by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2008 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781984105172 Total Pages :64 pages Book Rating :4.1/5 (51 download)
Book Synopsis Ensuring Safe Medicines and Medical Devices for Children by : United States. Congress
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-22 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring safe medicines and medical devices for children : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007.
Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Book Synopsis Safe Medical Devices for Children by : Institute of Medicine
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Book Synopsis FDA's Authority to Ensure that Drugs Prescribed to Children are Safe and Effective by : Susan Thaul
Download or read book FDA's Authority to Ensure that Drugs Prescribed to Children are Safe and Effective written by Susan Thaul and published by . This book was released on 2007 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs--the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003--and enacted a new law addressing devices--the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Book Synopsis Crossing the Quality Chasm by : Institute of Medicine
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-08-19 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Book Synopsis Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by : Institute of Medicine
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Book Synopsis Pediatric Patient Safety and Quality Improvement by : Karen S. Frush
Download or read book Pediatric Patient Safety and Quality Improvement written by Karen S. Frush and published by McGraw Hill Professional. This book was released on 2014-11-05 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: The guidance you need to protect your pediatric patients from medical error From front-line treatment to critical policy issues, Pediatric Patient Safety and Quality Improvement provides all the knowledge and insight you need to ensure your pediatric patients are treated safely and effectively. This unique guide addresses the specific challenges of medical professionals treating young patients. Packed with the newest research findings and best practices from top figures in the patient safety community, Pediatric Patient Safety and Quality Improvement will ensure that you provide optimum child care free of the oversights and errors for better patient outcomes. Pediatric Patient Safety and Quality Improvement offers the scientific information and current perspectives you need to: Build your expertise on the latest quality improvement methods Deepen your understanding of the human factors in medical mistakes Improve team efficacy for better care and outcomes in any setting
Book Synopsis The Role of Human Factors in Home Health Care by : National Research Council
Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
Book Synopsis 110-1&2 Legislative Calendar: Committee on Health, Education, Labor, and Pensions, S. Prt. 110-62, January 4, 2007-December 19, 2007, January 3, 2008-January 3, 2009, * by :
Download or read book 110-1&2 Legislative Calendar: Committee on Health, Education, Labor, and Pensions, S. Prt. 110-62, January 4, 2007-December 19, 2007, January 3, 2008-January 3, 2009, * written by and published by . This book was released on 2010 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe by : Susan Thaul
Download or read book FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe written by Susan Thaul and published by . This book was released on 2013-02-09 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Admin. (FDA) has approved for adult use many drugs that have been tested for adults but not for children. Yet clinicians often prescribe adult-approved drugs for children, a practice known as off-label prescribing, (1) because most drugs have not been tested in children, and (2) because clinicians presume that the safety and effectiveness demonstrated with adults generally means that the drugs are also safe and effective for children. However, research shows that this is not always true. Children may need higher or lower doses than adults, may experience effects on their growth and development, and may not respond to drugs approved for adults. Contents of this report: Understanding Drug Effects in Children; Why Manufacturers Have Not Tested Most Drugs in Children; Laws to Encourage Pediatric Drug Research; Issues for Reauthorization of These Laws; Concluding Comments. Tables. This is a print on demand report.
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :200 pages Book Rating :4.:/5 (319 download)
Book Synopsis Legislative Calendar by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Legislative Calendar written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2007 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Rational Therapeutics for Infants and Children by : Institute of Medicine
Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Book Synopsis Safe Medical Devices for Children by :
Download or read book Safe Medical Devices for Children written by and published by National Academy Press. This book was released on 2006-01-01 with total page 457 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Great Ormond Street Hospital Manual of Children's Nursing Practices by : Susan Macqueen
Download or read book The Great Ormond Street Hospital Manual of Children's Nursing Practices written by Susan Macqueen and published by John Wiley & Sons. This book was released on 2012-06-18 with total page 808 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical skills are a fundamental aspect of nursing care of children and young people. The Great Ormond Street Hospital Manual of Children's Nursing Practices is an evidence-based manual of practical skills in children's nursing which builds on the extensive expertise developed at Great Ormond Street Hospital. It encompasses all aspects of children's nursing from the most basic aspects of everyday practice to advanced practice in high dependency and intensive care to provide a comprehensive resource for all qualified nurses, students, and other health-care professionals involved in caring for children, both in the hospital and the community setting. Children's and young people's nursing presents unique challenges. The Great Ormond Street Hospital Manual utilises the latest clinical research and expert clinical knowledge to address these challenges, and provides the underlying theory and evidence for nursing care of children. It provides a definitive guide to clinical skills procedures in children's and young people's nursing which enables nurses working with children and young people to practice confidently and deliver clinically effective family-centred care. Key features Offers access to clinical procedures developed through the extensive expertise from Great Ormond Street Hospital Contains evidence-based recommendations for expert care Encompasses all aspects of children's care Contains procedures guidelines students can rely on and effectively use in practice following qualfication Highlights specific needs of neonates and adolescents Placed in the context of inter-disciplinary care of the child Includes the rationale for each procedure - the 'why' as well as 'how' Information presented in a similar way to The Royal Marsden Manual of Clinical Nursing Procedures - offering continuity to those working in both adult and paediatric settings This title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from iTunes or the MedHand Store.
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
