Fda In The Twenty First Century

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FDA in the Twenty-First Century

Author : Holly Fernandez Lynch
Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.2/5 (315 download)

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Book Synopsis FDA in the Twenty-First Century by : Holly Fernandez Lynch

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.

The Poison Squad

Author : Deborah Blum
Publisher : Penguin
ISBN 13 : 0525560289
Total Pages : 370 pages
Book Rating : 4.5/5 (255 download)

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Book Synopsis The Poison Squad by : Deborah Blum

Download or read book The Poison Squad written by Deborah Blum and published by Penguin. This book was released on 2018-09-25 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: A New York Times Notable Book The inspiration for PBS's AMERICAN EXPERIENCE film The Poison Squad. From Pulitzer Prize winner and New York Times-bestselling author Deborah Blum, the dramatic true story of how food was made safe in the United States and the heroes, led by the inimitable Dr. Harvey Washington Wiley, who fought for change By the end of nineteenth century, food was dangerous. Lethal, even. "Milk" might contain formaldehyde, most often used to embalm corpses. Decaying meat was preserved with both salicylic acid, a pharmaceutical chemical, and borax, a compound first identified as a cleaning product. This was not by accident; food manufacturers had rushed to embrace the rise of industrial chemistry, and were knowingly selling harmful products. Unchecked by government regulation, basic safety, or even labelling requirements, they put profit before the health of their customers. By some estimates, in New York City alone, thousands of children were killed by "embalmed milk" every year. Citizens--activists, journalists, scientists, and women's groups--began agitating for change. But even as protective measures were enacted in Europe, American corporations blocked even modest regulations. Then, in 1883, Dr. Harvey Washington Wiley, a chemistry professor from Purdue University, was named chief chemist of the agriculture department, and the agency began methodically investigating food and drink fraud, even conducting shocking human tests on groups of young men who came to be known as, "The Poison Squad." Over the next thirty years, a titanic struggle took place, with the courageous and fascinating Dr. Wiley campaigning indefatigably for food safety and consumer protection. Together with a gallant cast, including the muckraking reporter Upton Sinclair, whose fiction revealed the horrific truth about the Chicago stockyards; Fannie Farmer, then the most famous cookbook author in the country; and Henry J. Heinz, one of the few food producers who actively advocated for pure food, Dr. Wiley changed history. When the landmark 1906 Food and Drug Act was finally passed, it was known across the land, as "Dr. Wiley's Law." Blum brings to life this timeless and hugely satisfying "David and Goliath" tale with righteous verve and style, driving home the moral imperative of confronting corporate greed and government corruption with a bracing clarity, which speaks resoundingly to the enormous social and political challenges we face today.

FDA Regulatory Affairs

Author : Douglas J. Pisano
Publisher : CRC Press
ISBN 13 : 1040061974
Total Pages : 466 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano

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

Food Safety in the 21st Century

Author : Puja Dudeja
Publisher : Academic Press
ISBN 13 : 0128018461
Total Pages : 628 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Food Safety in the 21st Century by : Puja Dudeja

Download or read book Food Safety in the 21st Century written by Puja Dudeja and published by Academic Press. This book was released on 2016-09-28 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food Safety in the 21st Century: Public Health Perspective is an important reference for anyone currently working in the food industry or those entering the industry. It provides realistic, practical, and very usable information about key aspects of food safety, while also systematically approaching the matter of foodborne illness by addressing the intricacies of both prevention and control. This book discusses ways to assess risk and to employ epidemiological methods to improve food safety. In addition, it also describes the regulatory context that shapes food safety activities at the local, national, and international levels and looks forward to the future of food safety. - Provides the latest research and developments in the field of food safety - Incorporates practical, real-life examples for risk reduction - Includes specific aspects of food safety and the risks associated with each sector of the food chain, from food production, to food processing and serving - Describes various ways in which epidemiologic principles are applied to meet the challenges of maintaining a safe food supply in India and how to reduce disease outbreaks - Presents practical examples of foodborne disease incidents and their root causes to highlight pitfalls in food safety management

Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

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.

Reputation and Power

Author : Daniel Carpenter
Publisher : Princeton University Press
ISBN 13 : 1400835119
Total Pages : 825 pages
Book Rating : 4.4/5 (8 download)

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Book Synopsis Reputation and Power by : Daniel Carpenter

Download or read book Reputation and Power written by Daniel Carpenter and published by Princeton University Press. This book was released on 2014-04-24 with total page 825 pages. Available in PDF, EPUB and Kindle. Book excerpt: How the FDA became the world's most powerful regulatory agency The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested. Some images inside the book are unavailable due to digital copyright restrictions.

Innocent Casualties

Author : Elaine Feuer
Publisher : Blue Danube Publishing
ISBN 13 : 0988969130
Total Pages : 257 pages
Book Rating : 4.9/5 (889 download)

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Book Synopsis Innocent Casualties by : Elaine Feuer

Download or read book Innocent Casualties written by Elaine Feuer and published by Blue Danube Publishing. This book was released on 2013-10-03 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innocent Casualties is a well-documented expose that blows the whistle on the FDA and its 40-year war on alternative healing that may be costing hundreds of thousands of Americans the access to the very medicines that can save their lives. Innocent Casualties manages to make the blood boil in righteous anger, because it makes the FDA’s abuse of power so personal. Ms. Feuer takes the reader step-by-step through the nonsensical tactics, deceit, and police mentality, by disclosing the cunning and underhanded means used by the FDA to appear to be serving the people while actually abetting the cause of the international drug cartel.

3D Printing of Pharmaceuticals

Author : Abdul W. Basit
Publisher : Springer
ISBN 13 : 3319907557
Total Pages : 246 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis 3D Printing of Pharmaceuticals by : Abdul W. Basit

Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2018-08-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Bottle of Lies

Author : Katherine Eban
Publisher : HarperCollins
ISBN 13 : 0063054108
Total Pages : 523 pages
Book Rating : 4.0/5 (63 download)

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Book Synopsis Bottle of Lies by : Katherine Eban

Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a new postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine

Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Antibody-Drug Conjugates

Author : Jeffrey Wang
Publisher : Springer
ISBN 13 : 3319130811
Total Pages : 248 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Antibody-Drug Conjugates by : Jeffrey Wang

Download or read book Antibody-Drug Conjugates written by Jeffrey Wang and published by Springer. This book was released on 2015-03-05 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.

Lesser Known Monsters of the 21st Century

Author : Kim Fu
Publisher : Tin House Books
ISBN 13 : 1953534066
Total Pages : 232 pages
Book Rating : 4.9/5 (535 download)

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Book Synopsis Lesser Known Monsters of the 21st Century by : Kim Fu

Download or read book Lesser Known Monsters of the 21st Century written by Kim Fu and published by Tin House Books. This book was released on 2022-02-01 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The strange and wonderful define Kim Fu’s story collection, where the line between fantasy and reality fades in and out, elusive and beckoning." —The New York Times Book Review A LitHub, ALTA, and PureWow Best Book of the Month A BuzzFeed and WIRED Pick for a Book You Need to Read This Winter In the twelve unforgettable tales of Lesser Known Monsters of the 21st Century, the strange is made familiar and the familiar strange, such that a girl growing wings on her legs feels like an ordinary rite of passage, while a bug-infested house becomes an impossible, Kafkaesque nightmare. Each story builds a new world all its own: a group of children steal a haunted doll; a runaway bride encounters a sea monster; a vendor sells toy boxes that seemingly control the passage of time; an insomniac is seduced by the Sandman. These visions of modern life wrestle with themes of death and technological consequence, guilt and sexuality, and unmask the contradictions that exist within all of us. Mesmerizing, electric, and wholly original, Kim Fu’s Lesser Known Monsters of the 21st Century blurs the boundaries of the real and fantastic, offering intricate and surprising insights into human nature.

FDA Regulatory Affairs

Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)

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Book Synopsis FDA Regulatory Affairs by : David Mantus

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.

Enhancing Food Safety

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Enhancing Food Safety by : National Research Council

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.

The Cure in the Code

Author : Peter W Huber
Publisher : Basic Books
ISBN 13 : 0465069819
Total Pages : 306 pages
Book Rating : 4.4/5 (65 download)

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Book Synopsis The Cure in the Code by : Peter W Huber

Download or read book The Cure in the Code written by Peter W Huber and published by Basic Books. This book was released on 2013-11-12 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Never before have two revolutions with so much potential to save and prolong human life occurred simultaneously. The converging, synergistic power of the biochemical and digital revolutions now allows us to read every letter of life's code, create precisely targeted drugs to control it, and tailor their use to individual patients. Cancer, diabetes, Alzheimer's and countless other killers can be vanquished -- if we make full use of the tools of modern drug design and allow doctors the use of modern data gathering and analytical tools when prescribing drugs to their patients. But Washington stands in the way, clinging to outdated drug-approval protocols developed decades ago during medicine's long battle with the infectious epidemics of the past. Peter Huber, an expert in science, technology, and public policy, demonstrates why Washington's one-size-fits-all drug policies can't deal with diseases rooted in the complex molecular diversity of human bodies. Washington is ill-equipped to handle the torrents of data that now propel the advance of molecular medicine and is reluctant to embrace the statistical methods of the digital age that can. Obsolete economic policies, often rationalized as cost-saving measures, stifle innovation and suppress investment in the medicine that can provide the best cures at the lowest cost. In the 1980s, an AIDS diagnosis was a death sentence, until the FDA loosened its throttling grip and began streamlining and accelerating approval of life-saving drugs. The Cure in the Code shows patients, doctors, investors, and policy makers what we must now do to capture the full life-saving and cost-saving potential of the revolution in molecular medicine. America has to choose. At stake for America is the power to lead the world in mastering the most free, fecund, competitive, dynamic, and intelligent natural resource on the planet -- the molecular code that spawns human life and controls our health.

Bad Bug Book

Author : Mark Walderhaug
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781495203619
Total Pages : 292 pages
Book Rating : 4.2/5 (36 download)

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Book Synopsis Bad Bug Book by : Mark Walderhaug

Download or read book Bad Bug Book written by Mark Walderhaug and published by Createspace Independent Publishing Platform. This book was released on 2014-01-14 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Bad Bug Book 2nd Edition, released in 2012, provides current information about the major known agents that cause foodborne illness.Each chapter in this book is about a pathogen—a bacterium, virus, or parasite—or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses.A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference.The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services.