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Food And Drug Administration Modernization And Accountability Act Of 1997
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Author :United States. Congress. Senate. Committee on Labor and Human Resources Publisher : ISBN 13 : Total Pages :170 pages Book Rating :4.:/5 (327 download)
Book Synopsis Food and Drug Administration Modernization and Accountability Act of 1997 by : United States. Congress. Senate. Committee on Labor and Human Resources
Download or read book Food and Drug Administration Modernization and Accountability Act of 1997 written by United States. Congress. Senate. Committee on Labor and Human Resources and published by . This book was released on 1997 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
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.
Download or read book Regulatory procedures manual written by and published by . This book was released on 2004 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :172 pages Book Rating :4.0/5 ( download)
Book Synopsis Evaluating the Effectiveness of the Food And Drug Administration Modernization Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Evaluating the Effectiveness of the Food And Drug Administration Modernization Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2001 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease by : Institute of Medicine
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher : ISBN 13 : Total Pages :1190 pages Book Rating :4.F/5 ( download)
Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 1999: Agricultural programs, Farm Credit Administration by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 1999: Agricultural programs, Farm Credit Administration written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 1998 with total page 1190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies Publisher : ISBN 13 : Total Pages :1428 pages Book Rating :4.0/5 (18 download)
Book Synopsis Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1999: Department of Health and Human Services, Public Health Service by : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Download or read book Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1999: Department of Health and Human Services, Public Health Service written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and published by . This book was released on 1998 with total page 1428 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Historical Dictionary of the Clinton Era by : Richard Steven Conley
Download or read book Historical Dictionary of the Clinton Era written by Richard Steven Conley and published by Scarecrow Press. This book was released on 2012 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: William Jefferson Clinton's legacy remains a matter of significant contention among historians, political scientists, and pundits even after a decade of time to reflect. The Historical Dictionary of the Clinton Era covers both sides of the Clinton presidency through a chronology, an introductory essay, appendixes, and an extensive bibliography. --from publisher description.
Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine
Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Book Synopsis Drug Information by : Patrick M. Malone
Download or read book Drug Information written by Patrick M. Malone and published by McGraw Hill Professional. This book was released on 2010-05-12 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market
Book Synopsis Workbook and Lab Manual for Mosby's Pharmacy Technician E-Book by : Elsevier Inc
Download or read book Workbook and Lab Manual for Mosby's Pharmacy Technician E-Book written by Elsevier Inc and published by Elsevier Health Sciences. This book was released on 2021-04-20 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: This easy-to-use, chapter-by-chapter companion to Mosby's Pharmacy Technician: Principles and Practice, 6th Edition helps you solidify your understanding and mastery of key skills and concepts. Each chapter of this combination workbook and lab manual contains a wide variety of review questions, exercises, and experiential lab activities to help reinforce key concepts, encourage you to reflect critically, and relate to practice for success on the job. Combined with the core textbook, this learning package takes you from day one through graduation and certification! - Comprehensive content aligns with ASHP competencies and certification exam coverage. - Reinforce Key Concepts sections offer valuable review and practice. - Reflect Critically sections with realistic scenarios encourage content assimilation and application. - Relate to Practice sections with laboratory exercises provide hands-on practice to promote multi-dimensional skills mastery. - Skills checklists correlated to textbook procedures enable you to track your progress on key competencies. - NEW! Additional content ensures thorough coverage of all entry-level and many advanced ASHP accreditation competencies, including: - Wellness, disease prevention, and immunizations - Medication compliance and point-of-care testing - Professional and regulatory standards - Medication requiring special handling and documentation - Nonsterile and sterile compounding - Advanced Pharmacy Technician duties
Book Synopsis Positron Emission Tomography by : Birendra Kishore Das
Download or read book Positron Emission Tomography written by Birendra Kishore Das and published by Springer. This book was released on 2014-12-04 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides basic information about the relatively new and evolving technology –positron emission tomography- for its clinical applications and practical guidance for the referring physicians. Chapters cover application of PET in various clinical settings including oncology, cardiology, and neurology with a focus on role in various cancers. Because most of the new PET equipments come as hybrid machines with CT or MRI, two chapters have been included at the end of the book to provide basic and comprehensive information about these two technologies. Molecular imaging is going to revolutionize the way we practice medicine in the future. It will lead to more accurate diagnosis of diseases and its extent which will lead to better management and better outcomes. In the history of medicine no imaging modality has ever become so popular for use in such a short time as has the PET technology. PET imaging is mostly used in oncology, neurology and cardiology but also finds application in other situations such as infection imaging. The main focus, of course, is in management of cancer patients. PET (PET-CT) is not only very sensitive as it can detect changes in abnormal biochemical processes at cellular level but in one go all such areas can be detected in a whole body scan. It can show response to therapy, eradication of the disease or recurrence during the follow-up period. One of the main differences between a PET scan and other imaging tests like CT scan or MRI is that the PET scan reveals the cellular level metabolic changes occurring in an organ or tissue. This is important and unique because disease processes begin with functional changes at the cellular level. A PET scan can detect these very early changes whereas a CT or MRI detect changes much later as the disease begins to cause changes in the structure of organs or tissues. Some cancers, especially lymphoma or cancers of the head and neck, brain, lung, colon, or prostate, in very early stage may show up more clearly on a PET scan than on a CT scan or an MRI. A PET scan can measure such vital functions as blood flow, oxygen use, and glucose metabolism, which can help to evaluate the effectiveness of a patient’s treatment plan, allowing the course of care to be adjusted if necessary. Apart from its vital role in oncology it can estimate brain's blood flow and metabolic activity. A PET scan can help finding nervous system problems, such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, transient ischemic attack (TIA), amyotrophic lateral sclerosis (ALS), Huntington's disease, stroke, and schizophrenia. It can find changes in the brain that may cause epilepsy. PET scan is also increasingly being used to find poor blood flow to the heart, which may mean coronary artery disease. It can most accurately estimate the extent of damage to the heart tissue especially after a heart attack and help choose the best treatment, such as coronary artery bypass graft surgery, stenting or medical treatment. It can also contribute significantly in identifying areas exactly where radiotherapy is to be targeted avoiding unnecessary radiation exposure to surrounding tissue.
Book Synopsis A Practice of Anesthesia for Infants and Children, E-Book by : Charles J. Cote
Download or read book A Practice of Anesthesia for Infants and Children, E-Book written by Charles J. Cote and published by Elsevier Health Sciences. This book was released on 2024-05-18 with total page 5839 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering everything from preoperative evaluation to neonatal emergencies to the PACU, Coté, Lerman and Anderson's A Practice of Anesthesia in Infants and Children, 7th Edition, features state-of-the-art advice on the safe, effective administration of general and regional anesthesia and sedation strategies for young patients. This text reviews underlying scientific information, addresses preoperative assessment and anesthesia management in detail, and provides guidelines for postoperative care, emergencies, and special procedures. Comprehensive in scope and thoroughly up to date, this edition delivers unsurpassed coverage of every key aspect of pediatric anesthesia. - Presents must-know information on standards, techniques, and the latest advances in pediatric anesthesia from global experts in the field. - Contains thoroughly updated content throughout, with new contributors to lend a fresh perspective, updated figures and tables, and the latest information on perioperative fluid management, pharmacology, interventional devices, resuscitation, and more. - Covers key topics such as anesthetizing children with cancer, neonatal and pediatric emergencies, the obese child and bariatric surgery, interventional devices for children with congenital heart defects, cardiopulmonary resuscitation, simulation in pediatric anesthesia, patient safety and quality assurance, and more. - Features an extensive video library of pediatric anesthesia procedures, particularly difficult airway management strategies, new positioning devices, cardiac assist devices in action, management of burn injuries, how to perform ultrasound-guided regional anesthesia blocks and techniques, and much more. - Essentials chapters provide focused input from expert subspecialty pediatricians who share the latest information concerning hematology, pulmonology, oncology, hepatology, nephrology, and neurology. - Includes a laminated pocket reference guide with essential, practical information, and key references at the end of each chapter that provide a quick summary for review.
