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The Effect Of The Prescription Drug User Fee Act Of 1992 Pdufa On The Access And Safety Of New Prescription Drugs In The United States
Download The Effect Of The Prescription Drug User Fee Act Of 1992 Pdufa On The Access And Safety Of New Prescription Drugs In The United States full books in PDF, epub, and Kindle. Read online The Effect Of The Prescription Drug User Fee Act Of 1992 Pdufa On The Access And Safety Of New Prescription Drugs In The United States ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry by :
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pathway to Global Product Safety and Quality by : Margaret A. Hamburg
Download or read book Pathway to Global Product Safety and Quality written by Margaret A. Hamburg and published by DIANE Publishing. This book was released on 2012-10-07 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :128 pages Book Rating :4.0/5 ( download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of the Prescription Drug User Fee Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Future of Drug Safety by : Institute of Medicine
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 2007-03-27 with total page 347 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.
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 CDER ... Report to the Nation by : Center for Drug Evaluation and Research (U.S.)
Download or read book CDER ... Report to the Nation written by Center for Drug Evaluation and Research (U.S.) and published by . This book was released on 2002 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :270 pages Book Rating :4.:/5 (319 download)
Book Synopsis Reauthorization of PDUFA by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of PDUFA written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :88 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA User Fee Agreements by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book FDA User Fee Agreements written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Understanding Health Outcomes and Pharmacoeconomics by : George E. MacKinnon III
Download or read book Understanding Health Outcomes and Pharmacoeconomics written by George E. MacKinnon III and published by Jones & Bartlett Publishers. This book was released on 2011-09-22 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use. Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters. From the Introduction: "The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large." -- George E. MacKinnon III, PhD, RPh, FASHP
Book Synopsis Medical Innovation in the Changing Healthcare Marketplace by : National Research Council
Download or read book Medical Innovation in the Changing Healthcare Marketplace written by National Research Council and published by National Academies Press. This book was released on 2002-05-06 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: A wave of new health care innovation and growing demand for health care, coupled with uncertain productivity improvements, could severely challenge efforts to control future health care costs. A committee of the National Research Council and the Institute of Medicine organized a conference to examine key health care trends and their impact on medical innovation. The conference addressed the following question: In an environment of renewed concern about rising health care costs, where can public policy stimulate or remove disincentives to the development, adoption and diffusion of high-value innovation in diagnostics, therapeutics, and devices?
Author :United States. General Accounting Office Publisher :DIANE Publishing ISBN 13 :1428942831 Total Pages :63 pages Book Rating :4.4/5 (289 download)
Book Synopsis Prescription drugs OxyContin abuse and diversion and efforts to address the problem : report to congressional requesters. by : United States. General Accounting Office
Download or read book Prescription drugs OxyContin abuse and diversion and efforts to address the problem : report to congressional requesters. written by United States. General Accounting Office and published by DIANE Publishing. This book was released on 2003 with total page 63 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.
Book Synopsis Pharmaceutical Freedom by : Jessica Flanigan
Download or read book Pharmaceutical Freedom written by Jessica Flanigan and published by Oxford University Press. This book was released on 2017-07-03 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: If a competent adult refuses medical treatment, physicians and public officials must respect her decision. Coercive medical paternalism is a clear violation of the doctrine of informed consent, which protects patients' rights to make medical decisions even if a patient's choice endangers her health. The same reasons for rejecting medical paternalism in the doctor's office are also reasons to reject medical paternalism at the pharmacy, yet coercive medical paternalism persists in the form of premarket approval policies and prescription requirements for pharmaceuticals. In Pharmaceutical Freedom Jessica Flanigan defends patients' rights of self-medication. Flanigan argues that public officials should certify drugs instead of enforcing prohibitive pharmaceutical policies that disrespect people's rights to make intimate medical decisions and prevent patients from accessing potentially beneficial new therapies. This argument has revisionary implications for important and timely debates about medical paternalism, recreational drug legalization, human enhancement, prescription drug prices, physician assisted suicide, and pharmaceutical marketing. The need for reform is especially urgent as medical treatment becomes increasingly personalized and patients advocate for the right to try. The doctrine of informed consent revolutionized medicine in the twentieth century by empowering patients to make treatment decisions. Rights of self-medication are the next step.
Author :United States. Congress. House. Committee on Energy and Commerce Publisher : ISBN 13 : Total Pages :312 pages Book Rating :4.3/5 (121 download)
Book Synopsis Report on the Activity of the Committee on Energy and Commerce for the One Hundred Tenth Congress by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Report on the Activity of the Committee on Energy and Commerce for the One Hundred Tenth Congress written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2009 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmacology for Pharmacy Technicians - E-Book by : Kathy Moscou
Download or read book Pharmacology for Pharmacy Technicians - E-Book written by Kathy Moscou and published by Elsevier Health Sciences. This book was released on 2024-01-18 with total page 717 pages. Available in PDF, EPUB and Kindle. Book excerpt: Build a solid foundation in pharmacology with this all-in-one resource! Combining a comprehensive textbook with workbook exercises, Pharmacology for Pharmacy Technicians, 4th Edition helps you understand the principles of pharmacology and apply them to the daily activities and challenges seen in the practice setting. Full-color photos and illustrations make it easier to master concepts, and an in-depth review designed specifically for pharmacy technicians meets the requirements of the American Society of Health-System Pharmacists (ASHP) for anatomy and physiology and pharmacology. Written by a pharmacist and a pharmacy technician, Kathy Moscou and Karen Snipe — each with extensive experience in the field — this book helps you master the expanding role of the pharmacy technician and launch a successful and rewarding career in Pharmacy Technology. - Comprehensive coverage aligns with advanced-level ASHP competencies for accreditation and prepares you for certification. - Practical Pharm Tech features include Tech Alerts highlighting drug look-alike and sound-alike issues, Tech Notes with need-to-know information on safe drug dispensing, and Technician's Corner critical thinking exercises. - Coverage of A&P and medical terminology is included within each body system unit. - Quick-reference, mini drug monographs are included within each body system and drug classification chapter, and include pill photos along with generic and trade names, strength of medication, route of administration, dosage form, dosing schedule, and warning labels. - Learning features in each chapter include learning objectives, key terms, key points, and review questions. - Exam preparation includes two 120-question online practice exams in addition to board-style review questions. - Summary drug tables provide generic/brand name, drug strengths and dosage forms, usual dose and dosing schedule, and warning labels for at-a-glance access to important information. - NEW! Updated drug information ensures you are familiar with the latest drug approvals and the latest dosage and prescription guidelines. - NEW! Coverage of changes in pharmacology includes the newest pharmaceutical laws, handling and dispensing of controlled substances, COVID-19 developments, and advances in vaccines. - NEW! Integrated workbook exercises by chapter provide vocabulary practice, review questions, and case studies in the text as well as critical thinking and research activities online.
Book Synopsis Extending the Cure by : Ramanan Laxminarayan
Download or read book Extending the Cure written by Ramanan Laxminarayan and published by Routledge. This book was released on 2010-09-30 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Our ability to treat common bacterial infections with antibiotics goes back only 65 years. However, the authors of this report make it clear that sustaining a supply of effective and affordable antibiotics cannot be without changes to the incentives facing patients, physicians, hospitals, insurers, and pharmaceutical manufacturers. In fact, increasing resistance to these drugs is already exacting a terrible price. Every day in the United States, approximately 172 men, women, and children die from infections caused by antibiotic-resistant bacteria in hospitals alone. Beyond those deaths, antibiotic resistance is costing billions of dollars through prolonged hospital stays and the need for doctors to resort to ever more costly drugs to use as substitute treatments. Extending the Cure presents the problem of antibiotic resistance as a conflict between individual decision makers and their short-term interest and the interest of society as a whole, in both present and future: The effort that doctors make to please each patient by prescribing a drug when it might not be properly indicated, poor monitoring of discharged patients to ensure that they do not transmit drug-resistant pathogens to other persons, excesses in the marketing of new antibiotics, and the broad overuse of antibiotics all contribute to the development and spread of antibiotic-resistant bacteria. The book explores a range of policy options that would encourage patients, health care providers, and managed care organizations to serve as more responsible stewards of existing antibiotics as well as proposals that would give pharmaceutical firms greater incentives to develop new antibiotics and avoid overselling. If the problem continues unaddressed, antibiotic resistance has the potential to derail the health care system and return us to a world where people of all ages routinely die from simple infections. As a basis for future research and a spur to a critically important dialogue, Extending the Cure is a fundamental first step in addressing this public health crisis. The Extending the Cure project is funded in part by the Robert Wood Johnson Foundation through its Pioneer Portfolio.
