Food And Drug Administration S Review Process For Products To Treat Rare Diseases And Neglected Tropical Diseases
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United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Author : United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher : Unknown Page : 64 pages File Size : 51,8 Mb Release : 2011 Category : Medical ISBN : UCSD:31822037823424
Food and Drug Administration's Review Process for Products to Treat Rare Diseases and Neglected Tropical Diseases by United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Pdf
Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Publisher : National Academies Press Page : 442 pages File Size : 40,7 Mb Release : 2011-04-03 Category : Medical ISBN : 9780309158060
Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf
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 : World Health Organization Publisher : World Health Organization Page : 211 pages File Size : 41,5 Mb Release : 2015-08-05 Category : Medical ISBN : 9789241564861
Investing to Overcome the Global Impact of Neglected Tropical Diseases by World Health Organization Pdf
"The presence, or absence, of neglected tropical diseases (NTDs) can be seen as a proxy for poverty and for the success of interventions aimed at reducing poverty. Today, coverage of the public-health interventions recommended by the World Health Organization (WHO) against NTDs may be interpreted as a proxy for universal health coverage and shared prosperity - in short, a proxy for coverage against neglect. As the world's focus shifts from development to sustainable development, from poverty eradication to shared prosperity, and from disease-specific goals to universal health coverage, control of NTDs will assume an important role towards the target of achieving universal health coverage, including individual financial risk protection. Success in overcoming NTDs is a "litmus test" for universal health coverage against NTDs in endemic countries. The first WHO report on NTDs (2010) set the scene by presenting the evidence for how these interventions had produced results. The second report (2013) assessed the progress made in deploying them and detailed the obstacles to their implementation. This third report analyses for the first time the investments needed to achieve the scale up of implementation required to achieve the targets of the WHO Roadmap on NTDs and universal coverage against NTDs. INVESTING TO OVERCOME THE GLOBAL IMPACT OF NEGLECTED TROPICAL DISEASES presents an investment strategy for NTDs and analyses the specific investment case for prevention, control, elimination and eradication of 12 of the 17 NTDs. Such an analysis is justified following the adoption by the Sixty-sixth World Health Assembly in 2013 of resolution WHA6612 on neglected tropical diseases, which called for sufficient and predictable funding to achieve the Roadmap's targets and sustain control efforts. The report cautions, however, that it is wise investment and not investment alone that will yield success. The report registers progress and challenges and signals those that lie ahead. Climate change is expected to increase the spread of several vector-borne NTDs, notably dengue, transmission of which is directly influenced by temperature, rainfall, relative humidity and climate variability primarily through their effects on the vector. Investments in vector-borne diseases will avoid the potentially catastrophic expenditures associated with their control. The presence of NTDs will thereby signal an early warning system for climate-sensitive diseases. The ultimate goal is to deliver enhanced and equitable interventions to the most marginalized populations in the context of a changing public-health and investment landscape to ensure that all peoples affected by NTDs have an opportunity to lead healthier and wealthier lives."--Publisher's description.
Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Robert Giffin,Sally Robinson,Theresa Wizemann
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Robert Giffin,Sally Robinson,Theresa Wizemann Publisher : National Academies Press Page : 151 pages File Size : 50,9 Mb Release : 2009-02-17 Category : Medical ISBN : 9780309178167
Breakthrough Business Models by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Robert Giffin,Sally Robinson,Theresa Wizemann Pdf
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.
The Oxford Handbook of Intellectual Property Law by Rochelle C. Dreyfuss,Justine Pila Pdf
We live in an age in which expressive, informational, and technological subject matter are becoming increasingly important. Intellectual property is the primary means by which the law seeks to regulate such subject matter. It aims to promote innovation and creativity, and in doing so to support solutions to global environmental and health problems, as well as freedom of expression and democracy. It also seeks to stimulate economic growth and competition, accounting for its centrality to EU Internal Market and international trade and development policies. Additionally, it is of enormous and increasing importance to business. As a result there is a substantial and ever-growing interest in intellectual property law across all spheres of industry and social policy, including an interest in its legal principles, its social and normative foundations, and its place and operation in the political economy. This handbook written by leading academics and practitioners from the field of intellectual property law, and suitable for both a specialist legal readership and an intelligent but non-specialist legal and non-legal readership, provides a comprehensive account of the following areas: - The foundations of IP law, including its emergence and development in different jurisdictions and regions; - The substantive rules and principles of IP; and - Important issues arising from the existence and operation of IP in the political economy.
Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Publisher : National Academies Press Page : 366 pages File Size : 40,8 Mb Release : 2012-09-03 Category : Medical ISBN : 9780309224086
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Pdf
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.
Skin-Related Neglected Tropical Diseases (Skin-NTDs): A New Challenge by Roderick J. Hay,Kingsley Asiedu Pdf
This book is a printed edition of the Special Issue Skin-Related Neglected Tropical Diseases (Skin-NTDs)—A New Challenge that was published in TropicalMed
Author : Joel I. Shalowitz Publisher : John Wiley & Sons Page : 720 pages File Size : 43,5 Mb Release : 2019-09-04 Category : Medical ISBN : 9780470631522
The U.S. Healthcare System by Joel I. Shalowitz Pdf
Provides a diverse, multi-faceted approach to health care evaluation and management The U.S. Health Care System: Origins, Organization and Opportunities provides a comprehensive introduction and resource for understanding healthcare management in the United States. It brings together the many “moving parts” of this large and varied system to provide both a bird’s-eye view as well as relevant details of the complex mechanisms at work. By focusing on stakeholders and their interests, this book analyzes the value propositions of the buyers and sellers of healthcare products and services along with the interests of patients. The book begins with a presentation of frameworks for understanding the structure of the healthcare system and its dynamic stakeholder inter-relationships. The chapters that follow each begin with their social and historical origins, so the reader can fully appreciate how that area evolved. The next sections on each topic describe the current environment and opportunities for improvement. Throughout, the learning objectives focus on three areas: frameworks for understanding issues, essential factual knowledge, and resources to keep the reader keep up to date. Healthcare is a rapidly evolving field, due to the regulatory and business environments as well as the advance of science. To keep the content current, online updates are provided at: www.HealthcareInsights.MD. This website also offers a weekday blog of important/interesting news and teaching notes/class discussion suggestions for instructors who use the book as a text. The U.S. Health Care System: Origins, Organization and Opportunities is an ideal textbook for healthcare courses in MBA, MPH, MHA, and public policy/administration programs. In piloting the content, over the past several years the author has successfully used drafts of chapters in his Healthcare Systems course for MBA and MPH students at Northwestern University. The book is also useful for novice or seasoned suppliers, payers and providers who work across the healthcare field and want a wider or deeper understanding of the entire system.
Drug repurposing or drug repositioning is a new approach to presenting new indications for common commercial and clinically approved existing drugs. For example, chloroquine, an old antimalarial drug, showed promising results for treating COVID-19, interfering with MDR in several types of cancer, and chemosensitizing human leukemic cells.This book focuses on the hypothesis, risk/benefits, and economic impacts of drug repurposing on drug discovery in dermatology, infectious diseases, neurological disorders, cancer, and orphan diseases. It brings together up-to-date research to provide readers with an informative, illustrative, and easy-to-read book useful for students, clinicians, and the pharmaceutical industry.
Nanopharmaceutical Advanced Delivery Systems by Vivek Dave,Nikita Gupta,Srija Sur Pdf
The book provides a single volume covering detailed descriptions about various delivery systems, their principles and how these are put in use for the treatment of multiple diseases. It is divided into four sections where the first section deals with the introduction and importance of novel drug delivery system. The second section deals with the most advanced drug delivery systems like microbubbles, dendrimers, lipid-based nanoparticles, nanofibers, microemulsions etc., describing the major principles and techniques of the preparations of the drug delivery systems. The third section elaborates on the treatments of diverse diseases like cancer, topical diseases, tuberculosis etc. The fourth and final section provides a brief informative description about the regulatory aspects of novel drug delivery system that is followed in various countries.
Author : World Health Organization Publisher : World Health Organization Page : 73 pages File Size : 55,9 Mb Release : 2019-05-16 Category : Medical ISBN : 9789241210263
First WHO Model List of Essential In Vitro Diagnostics by World Health Organization Pdf
The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Author : World Health Organization Publisher : World Health Organization Page : 302 pages File Size : 52,7 Mb Release : 2010 Category : Health & Fitness ISBN : 9789241563970
Equity, Social Determinants and Public Health Programmes by World Health Organization Pdf
1. Introduction and methods of work.-- 2. Alcohol: equity and social determinants.-- 3. Cardiovascular disease: equity and social determinants.-- 4. Health and nutrition of children: equity and social determinants.-- 5. Diabetes: equity and social determinants.-- 6. Food safety: equity and social determinants.-- 7. Mental disorders: equity and social determinants.-- 8. Neglected tropical diseases: equity and social determinants.-- 9. Oral health: equity and social determinants.-- 10. Unintended pregnancy and pregnancy outcome: equity and social determinants.-- 11. Tobacco use: equity and social determinants.-- 12. Tuberculosis: the role of risk factors and social determinants.-- 13. Violence and unintentional injury: equity and social determinants.-- 14. Synergy for equity.
World Health Organization. Department of Control of Neglected Tropical Diseases,World Health Organization
Author : World Health Organization. Department of Control of Neglected Tropical Diseases,World Health Organization Publisher : World Health Organization Page : 184 pages File Size : 50,6 Mb Release : 2010 Category : Medical ISBN : 9789241564090
Working to Overcome the Global Impact of Neglected Tropical Diseases by World Health Organization. Department of Control of Neglected Tropical Diseases,World Health Organization Pdf
"Neglected tropical diseases (NTDs) blight the lives of a billion people worldwide and threaten the health of millions more. These ancient companions of poverty weaken impoverished populations, frustrate the achievement of health in the Millennium Development Goals and impede global health and economies has convinced governments, donors, the pharmaceutical industry and other agencies, including nongovernmental organizations (NGOs), to invest in preventing and controlling this diverse group of diseases. Global efforts to control "hidden" diseases, such as dracunculiasis (guinea-worm disease), leprosy, gains including the imminent eradication of dracunculiasis. Since 1989 (when most endemic countries began reporting monthly from each endemic village), the number of new dracunculiasis cases has fallen from 892 055 in 12 endemic countries to 3190 in 4 countries in 2009, a decrease of more than 99%. The World Health Organization (WHO) recommends five public-health strategies for the prevention and control of NTDs: preventive chemotherapy; intensified case-management; vector control; the provision of safe water, sanitation and hygiene; and veterinary public health (that is, applying veterinary sciences to ensure the health and well-being of humans). Although one approach and delivered locally." - p. vii
Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by World Intellectual Property Organization Pdf
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
