Drug Safety in the 21st Century
Author | : |
Publisher | : |
Total Pages | : 32 |
Release | : 2000 |
Genre | : |
ISBN | : |
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Author | : |
Publisher | : |
Total Pages | : 32 |
Release | : 2000 |
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Author | : Holly Fernandez Lynch |
Publisher | : Columbia University Press |
Total Pages | : 499 |
Release | : 2015-09-08 |
Genre | : Business & Economics |
ISBN | : 0231540078 |
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Author | : Mark McClellan |
Publisher | : |
Total Pages | : 13 |
Release | : 2007 |
Genre | : |
ISBN | : |
Author | : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions |
Publisher | : |
Total Pages | : 104 |
Release | : 2007 |
Genre | : Medical |
ISBN | : |
Author | : |
Publisher | : DIANE Publishing |
Total Pages | : 102 |
Release | : |
Genre | : |
ISBN | : 9781422320327 |
Author | : William Wang |
Publisher | : CRC Press |
Total Pages | : 347 |
Release | : 2021-12-30 |
Genre | : Mathematics |
ISBN | : 0429949995 |
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Author | : Puja Dudeja |
Publisher | : Academic Press |
Total Pages | : 628 |
Release | : 2016-09-28 |
Genre | : Technology & Engineering |
ISBN | : 0128018461 |
Food Safety in the 21st Century: Public Health Perspective is an important reference for anyone currently working in the food industry or those entering the industry. It provides realistic, practical, and very usable information about key aspects of food safety, while also systematically approaching the matter of foodborne illness by addressing the intricacies of both prevention and control. This book discusses ways to assess risk and to employ epidemiological methods to improve food safety. In addition, it also describes the regulatory context that shapes food safety activities at the local, national, and international levels and looks forward to the future of food safety. Provides the latest research and developments in the field of food safety Incorporates practical, real-life examples for risk reduction Includes specific aspects of food safety and the risks associated with each sector of the food chain, from food production, to food processing and serving Describes various ways in which epidemiologic principles are applied to meet the challenges of maintaining a safe food supply in India and how to reduce disease outbreaks Presents practical examples of foodborne disease incidents and their root causes to highlight pitfalls in food safety management
Author | : Jimmy Jose |
Publisher | : Springer |
Total Pages | : 0 |
Release | : 2024-07-22 |
Genre | : Medical |
ISBN | : 9783031510885 |
The science of drug safety and pharmacovigilance has rapidly evolved in the 21st century. The knowledge and principles it contains are of increasing importance in clinical and practice settings. The aim of this book is to deal with the gap in knowledge about pharmacovigilance and drug safety, including the application of pharmacovigilance knowledge to individual patient cases in clinical practice. A holistic approach is taken with each chapter written from the perspective of a practitioner, industry personnel, researcher, or regulator, creating a synergy between drug safety, pharmacovigilance, and clinical practice. Chapters offer key material on adverse drug reactions, medication errors, prescribing safety, pharmacovigilance as well as data sources used in drug safety and pharmacovigilance. Each chapter is structured as a self-contained learning resource, with learning objectives, and worked cases. The book is suitable for undergraduate healthcare professions, postgraduate students, researchers, clinical practitioners – including those with prescribing responsibilities. It will also be useful for professionals moving from a clinical practice role to a specialist pharmacovigilance role. For those already in a pharmacovigilance role, the book offers insight into the theory and practice of drug safety and pharmacovigilance in clinical settings.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 150 |
Release | : 2008-05-08 |
Genre | : Medical |
ISBN | : 0309110122 |
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.
Author | : United States Senate |
Publisher | : |
Total Pages | : 104 |
Release | : 2019-12-17 |
Genre | : |
ISBN | : 9781675771693 |
Building a 21st century FDA: proposals to improve drug safety and innovation: hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, second session, on examining proposals to improve drug safety and innovation, and S. 3807, to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug s