Author: Suzanne Parisian
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 680
Book Description
Parisian (formerly of the Food and Drug Administration, now a consultant) offers a guide to preparing clinical trials intended for submission to the FDA and for marketing purposes. She also provides an organizational map of the agency, outlining its requirements, procedures, and history, with an emphasis on the implications for medical practice, manufacturing, and marketing. The logic governing the agency and the rationale by which it makes its decisions are included in the coverage. Annotation copyrighted by Book News Inc., Portland, OR.
FDA, Inside & Out
Author: Suzanne Parisian
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 680
Book Description
Parisian (formerly of the Food and Drug Administration, now a consultant) offers a guide to preparing clinical trials intended for submission to the FDA and for marketing purposes. She also provides an organizational map of the agency, outlining its requirements, procedures, and history, with an emphasis on the implications for medical practice, manufacturing, and marketing. The logic governing the agency and the rationale by which it makes its decisions are included in the coverage. Annotation copyrighted by Book News Inc., Portland, OR.
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 680
Book Description
Parisian (formerly of the Food and Drug Administration, now a consultant) offers a guide to preparing clinical trials intended for submission to the FDA and for marketing purposes. She also provides an organizational map of the agency, outlining its requirements, procedures, and history, with an emphasis on the implications for medical practice, manufacturing, and marketing. The logic governing the agency and the rationale by which it makes its decisions are included in the coverage. Annotation copyrighted by Book News Inc., Portland, OR.
FDA's Drug Approval Process
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 100
Book Description
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 100
Book Description
The Food Defect Action Levels
Author:
Publisher:
ISBN:
Category : Food adulteration and inspection
Languages : en
Pages : 32
Book Description
Publisher:
ISBN:
Category : Food adulteration and inspection
Languages : en
Pages : 32
Book Description
Bottle of Lies
Author: Katherine Eban
Publisher: HarperCollins
ISBN: 0063054108
Category : Medical
Languages : en
Pages : 523
Book Description
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.
Publisher: HarperCollins
ISBN: 0063054108
Category : Medical
Languages : en
Pages : 523
Book Description
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.
FDA Consumer
Author:
Publisher:
ISBN:
Category : Consumer protection
Languages : en
Pages : 504
Book Description
Publisher:
ISBN:
Category : Consumer protection
Languages : en
Pages : 504
Book Description
FDA in the Twenty-First Century
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499
Book Description
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.
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499
Book Description
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.
Hearings
Author: United States. Congress. Senate. Committee on Appropriations
Publisher:
ISBN:
Category :
Languages : en
Pages : 1690
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 1690
Book Description
Heal Your Child from the Inside Out
Author: Robin Ray Green, L.Ac./MTCM
Publisher: Hay House, Inc
ISBN: 1401948707
Category : Health & Fitness
Languages : en
Pages : 273
Book Description
"With her brilliant mastery of the Chinese Five-Element System, as well as her compassionate understanding from her own experiences as a parent, Robin Ray Green is the perfect guide to show you how to read your child’s individual map. This book is a wonderfully practical and comprehensive ‘user’s manual’ for your child’s optimal health!” — Jean Haner, author of The Five Element Solution, and The Wisdom of Your Child’s Face: Discover Your Child’s True Nature with Chinese Face Reading Drawing from the ancient wisdom of the Five Elements of Traditional Chinese Medicine, Robin Ray Green, L.Ac., MTCM, offers simple solutions for creating a natural healing program that is as unique as your child. Questionnaires and quizzes help you gain an understanding of your child’s 5-Element type —whether it’s Wood, Fire, Earth, Metal or Water —to allow you to diagnose imbalances within the body that create health issues. Once you’ve gained a solid understanding of the 5 Elements and how health conditions are affected by elemental imbalances, nutrition, and lifestyle, you’ll learn simple techniques —such as acupressure, massage, and meditation —that will help your child achieve vibrant health. Ultimately, empowered with this knowledge and a new, holistic perspective on health, you’ll be able to augment Western treatments with time-tested natural solutions to help your child, and your whole family, heal naturally.
Publisher: Hay House, Inc
ISBN: 1401948707
Category : Health & Fitness
Languages : en
Pages : 273
Book Description
"With her brilliant mastery of the Chinese Five-Element System, as well as her compassionate understanding from her own experiences as a parent, Robin Ray Green is the perfect guide to show you how to read your child’s individual map. This book is a wonderfully practical and comprehensive ‘user’s manual’ for your child’s optimal health!” — Jean Haner, author of The Five Element Solution, and The Wisdom of Your Child’s Face: Discover Your Child’s True Nature with Chinese Face Reading Drawing from the ancient wisdom of the Five Elements of Traditional Chinese Medicine, Robin Ray Green, L.Ac., MTCM, offers simple solutions for creating a natural healing program that is as unique as your child. Questionnaires and quizzes help you gain an understanding of your child’s 5-Element type —whether it’s Wood, Fire, Earth, Metal or Water —to allow you to diagnose imbalances within the body that create health issues. Once you’ve gained a solid understanding of the 5 Elements and how health conditions are affected by elemental imbalances, nutrition, and lifestyle, you’ll learn simple techniques —such as acupressure, massage, and meditation —that will help your child achieve vibrant health. Ultimately, empowered with this knowledge and a new, holistic perspective on health, you’ll be able to augment Western treatments with time-tested natural solutions to help your child, and your whole family, heal naturally.
Diagnostic Ultrasound Imaging: Inside Out
Author: Thomas L. Szabo
Publisher: Academic Press
ISBN: 012396542X
Category : Science
Languages : en
Pages : 829
Book Description
Diagnostic Ultrasound Imaging provides a unified description of the physical principles of ultrasound imaging, signal processing, systems and measurements. This comprehensive reference is a core resource for both graduate students and engineers in medical ultrasound research and design. With continuing rapid technological development of ultrasound in medical diagnosis, it is a critical subject for biomedical engineers, clinical and healthcare engineers and practitioners, medical physicists, and related professionals in the fields of signal and image processing. The book contains 17 new and updated chapters covering the fundamentals and latest advances in the area, and includes four appendices, 450 figures (60 available in color on the companion website), and almost 1,500 references. In addition to the continual influx of readers entering the field of ultrasound worldwide who need the broad grounding in the core technologies of ultrasound, this book provides those already working in these areas with clear and comprehensive expositions of these key new topics as well as introductions to state-of-the-art innovations in this field. - Enables practicing engineers, students and clinical professionals to understand the essential physics and signal processing techniques behind modern imaging systems as well as introducing the latest developments that will shape medical ultrasound in the future - Suitable for both newcomers and experienced readers, the practical, progressively organized applied approach is supported by hands-on MATLAB® code and worked examples that enable readers to understand the principles underlying diagnostic and therapeutic ultrasound - Covers the new important developments in the use of medical ultrasound: elastography and high-intensity therapeutic ultrasound. Many new developments are comprehensively reviewed and explained, including aberration correction, acoustic measurements, acoustic radiation force imaging, alternate imaging architectures, bioeffects: diagnostic to therapeutic, Fourier transform imaging, multimode imaging, plane wave compounding, research platforms, synthetic aperture, vector Doppler, transient shear wave elastography, ultrafast imaging and Doppler, functional ultrasound and viscoelastic models
Publisher: Academic Press
ISBN: 012396542X
Category : Science
Languages : en
Pages : 829
Book Description
Diagnostic Ultrasound Imaging provides a unified description of the physical principles of ultrasound imaging, signal processing, systems and measurements. This comprehensive reference is a core resource for both graduate students and engineers in medical ultrasound research and design. With continuing rapid technological development of ultrasound in medical diagnosis, it is a critical subject for biomedical engineers, clinical and healthcare engineers and practitioners, medical physicists, and related professionals in the fields of signal and image processing. The book contains 17 new and updated chapters covering the fundamentals and latest advances in the area, and includes four appendices, 450 figures (60 available in color on the companion website), and almost 1,500 references. In addition to the continual influx of readers entering the field of ultrasound worldwide who need the broad grounding in the core technologies of ultrasound, this book provides those already working in these areas with clear and comprehensive expositions of these key new topics as well as introductions to state-of-the-art innovations in this field. - Enables practicing engineers, students and clinical professionals to understand the essential physics and signal processing techniques behind modern imaging systems as well as introducing the latest developments that will shape medical ultrasound in the future - Suitable for both newcomers and experienced readers, the practical, progressively organized applied approach is supported by hands-on MATLAB® code and worked examples that enable readers to understand the principles underlying diagnostic and therapeutic ultrasound - Covers the new important developments in the use of medical ultrasound: elastography and high-intensity therapeutic ultrasound. Many new developments are comprehensively reviewed and explained, including aberration correction, acoustic measurements, acoustic radiation force imaging, alternate imaging architectures, bioeffects: diagnostic to therapeutic, Fourier transform imaging, multimode imaging, plane wave compounding, research platforms, synthetic aperture, vector Doppler, transient shear wave elastography, ultrafast imaging and Doppler, functional ultrasound and viscoelastic models
Hearing aids inside out
Author: deafness
Publisher: Aldo Press
ISBN:
Category : Health & Fitness
Languages : en
Pages : 112
Book Description
Are you frequentely requesting people to repeat their comments to you? Is the volume button on your telephone turned to the highest notch? Don't enjoy music with low volume?
Publisher: Aldo Press
ISBN:
Category : Health & Fitness
Languages : en
Pages : 112
Book Description
Are you frequentely requesting people to repeat their comments to you? Is the volume button on your telephone turned to the highest notch? Don't enjoy music with low volume?