Development Of Fda Regulated Medical Products

Author : Elaine Whitmore
Publisher : Quality Press
ISBN 13 : 0873892216
Total Pages : 257 pages
Book Rating : 4.16/5 ( download)

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Download or read book Development of FDA-Regulated Medical Products written by Elaine Whitmore and published by Quality Press. This book was released on 2012-02-15 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. "I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients!" Joseph P. Sener, P.E.

Author : Elaine Whitmore
Publisher : ASQ Quality Press
ISBN 13 : 9780873894166
Total Pages : 186 pages
Book Rating : 4.62/5 ( download)

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Download or read book Product Development Planning for Health Care Products Regulated by the FDA written by Elaine Whitmore and published by ASQ Quality Press. This book was released on 1997 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.06/5 ( download)

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Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Author : Joanne S. Hawana
Publisher :
ISBN 13 :
Total Pages : 185 pages
Book Rating : 4.06/5 ( download)

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Download or read book Promotion of FDA-regulated Medical Products written by Joanne S. Hawana and published by . This book was released on 2018 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promotion of FDA-Regulated Medical Products is the update of the 2013 publication, FDA requirements for prescription drug promotion, by John Driscoll.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.58/5 ( download)

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Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Author : Eunjoo Pacifici
Publisher : Academic Press
ISBN 13 : 0128111569
Total Pages : 280 pages
Book Rating : 4.67/5 ( download)

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Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Author : Jonathan S. Kahan
Publisher :
ISBN 13 : 9780996346276
Total Pages : 658 pages
Book Rating : 4.79/5 ( download)

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Download or read book Medical Device Development written by Jonathan S. Kahan and published by . This book was released on 2020 with total page 658 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.01/5 ( download)

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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.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.60/5 ( download)

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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.

Author : Holly Fernandez Lynch
Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.70/5 ( download)

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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.