Download or read book Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings written by and published by . This book was released on 2008 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidance for FDA Advisory Committee Members and FDA Staff written by and published by . This book was released on 2008 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Download or read book Guidance for the Public FDA Advisory Committee Members and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees written by and published by . This book was released on 2008 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Optimizing the Process for Establishing the Dietary Guidelines for Americans written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-12-16 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal guidance on nutrition and diet is intended to reflect the state of the science and deliver the most reliable recommendations possible according to the best available evidence. This guidance, updated and presented every 5 years in the Dietary Guidelines for Americans (DGA), serves as the basis for all federal nutrition policies and nutrition assistance programs, as well as nutrition education programs. Despite the use of the guidelines over the past 30 years, recent challenges prompted Congress to question the process by which food and nutrition guidance is developed. This report assesses the process used to develop the guidelines; it does not evaluate the substance or use of the guidelines. As part of an overall, comprehensive review of the process to update the DGA, this first report seeks to discover how the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints for the purpose of informing the 2020 cycle.
Download or read book Foundations of EU Food Law and Policy written by Alberto Alemanno and published by Routledge. This book was released on 2016-04-15 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents the viewpoints of academics, food lawyers, industry and consumer representatives as well as those of EU policymakers on the first ten years of activity of one of the most prominent European agencies. Its broader purpose, however, is to discuss the future role played by EFSA within the rapidly-evolving area of EU food law and policy. By revisiting and discussing the milestones in the history of EFSA, the collection provides forward-looking views of food leaders and practitioners on the future scientific and regulatory challenges facing the European Union. In particular, by presenting a critical assessment of the agency’s activities within its different areas of work, the book offers readers a set of innovative tools for evaluating policy recommendations and better equips experts and the public to address pressing regulatory issues in this emotive area of law and policy. Despite its celebratory mood, the book’s focus is more about the future than the past of EU food law and policy. Each chapter discusses how EFSA’s role has evolved and identifies what it should have done differently while presenting an overall assessment of how the agency has discharged its mandate.
Download or read book Federal Register written by and published by . This book was released on 2013 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register Index written by and published by . This book was released on 2006 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer. This book was released on 2015-08-27 with total page 563 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.
Download or read book FDA in the Twenty First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 2007-02-27 with total page 346 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.
Download or read book Federal Register written by and published by . This book was released on 2008-08 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Download or read book Pediatric Bioethics written by Geoffrey Miller and published by Cambridge University Press. This book was released on 2010 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume offers a theoretical and practical overview of the ethics of pediatric medicine. It serves as a fundamental handbook and resource for pediatricians, nurses, residents in training, graduate students, and practitioners of ethics and healthcare policy. Written by a team of leading experts, Pediatric Bioethics addresses those difficult ethical questions concerning the clinical and academic practice of pediatrics, including an approach to recognizing boundaries when confronted with issues such as end of life care, life-sustaining treatment, extreme prematurity, pharmacotherapy, and research. Thorny topics such as what constitutes best interests, personhood, or distributive justice and public health concerns such as immunization and newborn genetic screening are also addressed.
