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 FDA Advisory Committees Process for Recruiting Members and Evaluating Potential Conflicts of Interest written by and published by DIANE Publishing. This book was released on with total page 67 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 FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Download or read book Bending Science written by Thomas O. McGarity and published by . This book was released on 2010 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: With alarming stories drawn from the public record, McGarity and Wagner describe how advocates attempt to bend science or 'spin' findings. They reveal an immense range of tools available to shrewd partisans determined to manipulate research.
Download or read book Public Health Reports written by and published by . This book was released on 2008 with total page 878 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 Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-10-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download or read book Food Safety written by Lisa Shames and published by DIANE Publishing. This book was released on 2010-06 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA is not required to review substances, such as spices and preservatives, added to food that are Generally Recognized as Safe (GRAS) for their intended use. A few substances previously considered GRAS have later been banned; and concerns have been raised about the safety of other GRAS substances, including materials manufactured at a tiny scale to take advantage of novel properties. This report reviewed the extent to which: (1) FDA's oversight of new GRAS determinations helps ensure the safety of these substances; (2) FDA ensures the continued safety of current GRAS substances; and (3) FDA's approach to regulating engineered nano-materials in GRAS substances helps ensure the safety of the food supply. Illus.
Download or read book Public Health Reports written by and published by . This book was released on 2008 with total page 860 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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:
Download or read book Is the U S Department of Veterans Affairs Meeting the Pharmaceutical Needs of Veterans written by United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Health and published by . This book was released on 2010 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 The Food and Drug Administration s Critical Mission and Challenges for the Future written by United States. Congress. House. Committee on Oversight and Government Reform and published by . This book was released on 2007 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Doubt Is Their Product written by David Michaels and published by Oxford University Press. This book was released on 2008-04-23 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Doubt is our product," a cigarette executive once observed, "since it is the best means of competing with the 'body of fact' that exists in the minds of the general public. It is also the means of establishing a controversy." In this eye-opening expose, David Michaels reveals how the tobacco industry's duplicitous tactics spawned a multimillion dollar industry that is dismantling public health safeguards. Product defense consultants, he argues, have increasingly skewed the scientific literature, manufactured and magnified scientific uncertainty, and influenced policy decisions to the advantage of polluters and the manufacturers of dangerous products. To keep the public confused about the hazards posed by global warming, second-hand smoke, asbestos, lead, plastics, and many other toxic materials, industry executives have hired unscrupulous scientists and lobbyists to dispute scientific evidence about health risks. In doing so, they have not only delayed action on specific hazards, but they have constructed barriers to make it harder for lawmakers, government agencies, and courts to respond to future threats. The Orwellian strategy of dismissing research conducted by the scientific community as "junk science" and elevating science conducted by product defense specialists to "sound science" status also creates confusion about the very nature of scientific inquiry and undermines the public's confidence in science's ability to address public health and environmental concerns Such reckless practices have long existed, but Michaels argues that the Bush administration deepened the dysfunction by virtually handing over regulatory agencies to the very corporate powers whose products and behavior they are charged with overseeing. In Doubt Is Their Product Michaels proves, beyond a doubt, that our regulatory system has been broken. He offers concrete, workable suggestions for how it can be restored by taking the politics out of science and ensuring that concern for public safety, rather than private profits, guides our regulatory policy. Named one of the best Sci-Tech books of 2008 by Library Journal!
