Strategy And Science At The Fda
DOWNLOAD
Download Strategy And Science At The Fda PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Strategy And Science At The Fda book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Strategy And Science At The Fda
DOWNLOAD
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
DOWNLOAD
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.
Fda Science And Mission At Risk
DOWNLOAD
Author : Barry Leonard
language : en
Publisher: DIANE Publishing
Release Date : 2009-12
Fda Science And Mission At Risk written by Barry Leonard and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-12 with Health & Fitness categories.
The Food and Drug Admin. (FDA¿s) responsibilities for protecting the health of Americans are far-reaching. This report assesses whether FDA¿s current science and technology was sufficient to protect the nation¿s food and drug supply. The FDA Science Board undertook this review and included outside experts from industry, academia, and other gov¿t. agencies. The report, more than a year in the making, is one of the most comprehensive examinations of the FDA in its history. It concludes that the FDA cannot fulfill its mission because: its scientific base has eroded and its scientific organizational structure is weak; its scientific workforce does not have sufficient capacity and capability; and its information technology infrastructure is inadequate.
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development
DOWNLOAD
Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-04-04
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development 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 2012-04-04 with Medical categories.
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Scientific Advice Meetings
DOWNLOAD
Author : Cf Harrison
language : en
Publisher: Independently Published
Release Date : 2023-10-27
Scientific Advice Meetings written by Cf Harrison and has been published by Independently Published this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-10-27 with categories.
Ensure that your advice meetings lead to a positive outcome. Every drug development program has problems. But sometimes more difficult challenges arise. Ones which require discussion with regulatory authorities such as FDA to solve. It will happen to you. And you will have one chance to get this right. One chance to provide your detailed, scientific arguments to the authority and sway them to your point of view. Success means the development program will continue on down the path of your choice. Failure can lead to cost overruns, delays or even cancellation of the project. Don't waste this chance. Purchase this guide. We will: Provide a step-by-step guide: With in-depth discussion of each part of the process, from initial idea generation through to post-meeting stakeholder management, you can ensure that nothing is missed. Help determine your ideal strategy: Via a comprehensive guide to developing a formalized statement of what you want to achieve, perfect for keeping the team on track and getting management buy-in. Encourage persuasive writing: Information on structuring a briefing book, developing your chain of logic, and the art of writing ensures that you will maximize your chances of success. Help new and experienced professionals: Providing baseline knowledge for those new to the field as well as tips and tricks for late-career experts. How does it manage this? We've included the following chapters: Chapters 1 & 2 provide baseline knowledge for people entering the field, including the role that regulatory authorities play, their expectations, and information on the meeting types offered by FDA, EMA, PMDA and NMPA. Chapter 3 discusses best practice for creating a strategy and formalizing it into a document for team discussions and stakeholder management. Chapters 4 and 5 describes the requirements for the initial application, then the process of creating a persuasive and comprehensive briefing book. Chapters 6 and 7 cover preparation for the meeting - the initial practice rounds, dealing with challenge sessions, interpreting the preliminary feedback, then finalizing your strategy and company presentation. Chapters 8 and 9 describe best practices for the meeting itself and the activities which need to occur after it has been held. Finally several appendices discuss writing skills for persuasive documents, review best practice, and problem solving skills. Sounds helpful for your current situation? Then take a look today.
Development Of Fda Regulated Medical Products
DOWNLOAD
Author : Elaine Whitmore
language : en
Publisher: Quality Press
Release Date : 2012-02-15
Development Of Fda Regulated Medical Products written by Elaine Whitmore and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-15 with Medical categories.
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.
Food Safety
DOWNLOAD
Author : Lisa Shames
language : en
Publisher: DIANE Publishing
Release Date : 2010-10
Food Safety 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 2010-10 with Technology & Engineering categories.
The U.S. faces challenges to ensuring food safety. First, imported food makes up a substantial and growing portion of the U.S. food supply, with 60% of fresh fruits and vegetables and 80% of seafood coming from across our borders. In recent years, there has been an increase in reported outbreaks of foodborne illness associated with both domestic and imported produce. This report focuses primarily on the FDAs: (1) progress in addressing selected recommend. identified by the FDA Science Board; (2) incorp. of scientific and risk analysis into its oversight of the accuracy of food labeling, fresh produce, and the safety of dietary supplements; and (3) a new computer screening tool that may improve its efforts to screen imports using a risk-based approach.
Enhancing Food Safety
DOWNLOAD
Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-12-04
Enhancing Food Safety written by National Research Council 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 2010-12-04 with Medical categories.
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.
Mastering And Managing The Fda Maze Second Edition
DOWNLOAD
Author : Gordon Harnack
language : en
Publisher: Quality Press
Release Date : 2014-04-14
Mastering And Managing The Fda Maze Second Edition written by Gordon Harnack and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-14 with Business & Economics categories.
The number of FDA regulations and the agencys increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firms employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
Advancing Regulatory Science For Public Health
DOWNLOAD
Author : Barry Leonard
language : en
Publisher: DIANE Publishing
Release Date : 2011
Advancing Regulatory Science For Public Health written by Barry Leonard and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Health & Fitness categories.
This is a print on demand edition of a hard to find publication. Recent breakthroughs in science and tech. -- ranging from sequencing of the human genome to advances in the application of nanotech. to new medical products -- may transform our ability to prevent, diagnose and treat disease. Similarly, advances in research and IT enable us to more efficiently identify microbial pathogens, track food contamination outbreaks and determine where foods and other FDA-regulated products are produced or manufactured, how they are transported, where they go and who uses them. This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA to strengthen the field, both within the agency and throughout the Nation. Illustrations.