Download or read book Food and Drug Administration s Review Process for Products to Treat Rare Diseases and Neglected Tropical Diseases written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2017-12-24 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C.
Download or read book Food and Drug Administration s Review Process for Products to Treat Rare Diseases and Neglected Tropical Diseases written by United States Senate and published by . This book was released on 2019-09-08 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases: hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C.
Download or read book Food and Drug Administration s Review Process for Products to Treat Rare Diseases and Neglected Tropical Diseases written by United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2011 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration s Review Process for Products to Treat Rare Diseases and Neglected Tropical Diseases written by United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2011 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Rare Diseases written by Marcia Crosse and published by . This book was released on 2016-05-04 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Almost 7,999 rare diseases, most of which are serious or life-threatening, affect more than 25 million Americans. About half of all rare diseases affect children, and few of these diseases have viable treatments. To encourage the development of drugs to treat or prevent rare pediatric diseases, the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 authorized FDA to award a priority review voucher to a drug sponsor upon approval of that sponsor's drug to treat a rare pediatric disease. A drug sponsor can later redeem the voucher when submitting another new drug application to treat any disease or condition in adults or children, or sell or transfer the voucher to another sponsor. A voucher entitles a sponsor to a 6-month priority review by FDA rather than the 10-month standard review. This report examined what is known abut the effectiveness of the pediatric voucher program. Table and figure. This is a print on demand report.
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.
Download or read book Skin Related Neglected Tropical Diseases Skin NTDs A New Challenge written by Roderick J. Hay and published by MDPI. This book was released on 2019-07-31 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Nanopharmaceutical Advanced Delivery Systems written by Vivek Dave and published by John Wiley & Sons. This book was released on 2020-12-29 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book First WHO Model List of Essential In Vitro Diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 2010 with total page 1490 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Economic Dimensions of Personalized and Precision Medicine written by Ernst R. Berndt and published by University of Chicago Press. This book was released on 2019-04-22 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement of PPM is a challenge in traditional clinical, reimbursement, and regulatory landscapes because it is costly to develop and introduces a wide range of scientific, clinical, ethical, and socioeconomic issues. PPM raises a multitude of economic issues, including how information on accurate diagnosis and treatment success will be disseminated and who will bear the cost; changes to physician training to incorporate genetics, probability and statistics, and economic considerations; questions about whether the benefits of PPM will be confined to developed countries or will diffuse to emerging economies with less developed health care systems; the effects of patient heterogeneity on cost-effectiveness analysis; and opportunities for PPM’s growth beyond treatment of acute illness, such as prevention and reversal of chronic conditions. This volume explores the intersection of the scientific, clinical, and economic factors affecting the development of PPM, including its effects on the drug pipeline, on reimbursement of PPM diagnostics and treatments, and on funding of the requisite underlying research; and it examines recent empirical applications of PPM.
Download or read book Working to Overcome the Global Impact of Neglected Tropical Diseases written by World Health Organization. Department of Control of Neglected Tropical Diseases and published by World Health Organization. This book was released on 2010 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Equity Social Determinants and Public Health Programmes written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Global Health and the Future Role of the United States written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-05 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: While much progress has been made on achieving the Millenium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency â€" both within the U.S. government and across the global health field.
Download or read book Drug Repurposing written by Farid A. Badria and published by BoD – Books on Demand. This book was released on 2020-12-02 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
