Challenges For The Fda
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Challenges For The Fda
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-11-02
Challenges For The Fda written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-02 with Medical categories.
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
Fda In The Twenty First Century
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Author : Holly Fernandez Lynch
language : en
Publisher: Columbia University Press
Release Date : 2015-09-08
Fda In The Twenty First Century written by Holly Fernandez Lynch and has been published by Columbia University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-08 with Business & Economics categories.
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.
Food And Drug Administration
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Author : Marcia Crosse
language : en
Publisher: DIANE Publishing
Release Date : 2010
Food And Drug Administration written by Marcia Crosse and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
Twenty years ago, it was reported that the FDA was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products -- human drugs, biologics, and medical devices -- marketed for sale in the U.S. Since then, concerns have been raised regarding FDA's ability to meet its oversight responsibilities. This report reviews the resources supporting FDA's medical product oversight responsibilities. It examines trends in: (1) FDA's funding and staffing resources for its medical product oversight responsibilities from FY 1999 through 2008; and (2) FDA's medical product oversight responsibilities during this same period. Charts and tables.
Food And Drug Administration
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Author : Lisa Shames
language : en
Publisher: DIANE Publishing
Release Date : 2010-08
Food And Drug Administration written by Lisa Shames and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-08 with Political Science categories.
Reviews the FDA¿s strategic planning and mgmt. Leading practices in this area include developing strategies to address mgmt. challenges and results-oriented performance measures, aligning activities and resources to strategic goals, and enhancing the use of performance info. The report examined the extent to which: (1) FDA's Strategic Action Plan contains strategies to address its mgmt. challenges, and the progress FDA has reported in addressing those challenges; (2) FDA's annual performance measures are results-oriented; (3) FDA has aligned its activities and resources to support its strategic goals; and (4) FDA managers report using performance info. in decision making and applying key practices to encourage that use. Illustrations.
Combination Products
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Author : Smita Gopalaswamy
language : en
Publisher: CRC Press
Release Date : 2008-04-22
Combination Products written by Smita Gopalaswamy and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-22 with Business & Economics categories.
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
Strategy And Science At The Fda
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Author : Daniel N. Reed
language : en
Publisher: Nova Science Publishers
Release Date : 2012-03
Strategy And Science At The Fda written by Daniel N. Reed and has been published by Nova Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03 with Drugs categories.
FDA's primary responsibility is to protect the American people from unsafe or mislabelled food, drugs, and other medical products and to make sure consumers have access to accurate, science-based information about the products they need and rely on every day. The agency also guides and oversees the development and availability of effective new medical products and new food products that harness the latest advances in science and technology to improve the health and well-being of American consumers. This book explores the FDA's strategic priorities and vision for the future which includes a transformed and integrated global food system, focused on prevention and improved nutrition, as well as an investment in medical science and technology, to ultimately better promote and protect the health of the American people.
Food And Drug Administration
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Author : U S Government Accountability Office (G
language : en
Publisher: BiblioGov
Release Date : 2013-06
Food And Drug Administration written by U S Government Accountability Office (G and has been published by BiblioGov this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06 with categories.
GAO was asked to review the Food and Drug Administration's (FDA) strategic planning and management. Leading practices in this area include developing strategies to address management challenges and results-oriented performance measures, aligning activities and resources to strategic goals, and enhancing the use of performance information. In this report, GAO examined the extent to which (1) FDA's Strategic Action Plan contains strategies to address its management challenges, and the progress FDA has reported in addressing those challenges; (2) FDA's annual performance measures are results-oriented; (3) FDA has aligned its activities and resources to support its strategic goals; and (4) FDA managers report using performance information in decision making and applying key practices to encourage that use. GAO surveyed FDA managers; analyzed reports on FDA to identify its management challenges; reviewed FDA and other documents, prior GAO work, and surveys of federal managers; and interviewed FDA officials.
Fda Checkup
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Author : United States. Congress
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-09-24
Fda Checkup written by United States. Congress and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-24 with categories.
FDA checkup : drug development and manufacturing challenges
Medical Devices
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Author : United States Government Accountability Office
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2018-01-25
Medical Devices written by United States Government Accountability Office and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-25 with categories.
Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections
Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials
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Author : CreateSpace Independent Publishing Platform
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2018-07-03
Challenges To Fda S Ability To Monitor And Inspect Foreign Clinical Trials written by CreateSpace Independent Publishing Platform and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-07-03 with categories.
Challenges to FDA's ability to monitor and inspect foreign clinical trials