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Author: Suzanne Parisian Publisher: ISBN: Category : 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.
Author: Suzanne Parisian Publisher: ISBN: Category : 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.
Author: Fran Hawthorne Publisher: John Wiley & Sons ISBN: 1118040066 Category : Business & Economics Languages : en Pages : 393
Book Description
The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher: ISBN: Category : Medical Languages : en Pages : 100
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?
Author: Katherine Eban Publisher: HarperCollins ISBN: 0063054108 Category : Medical Languages : en Pages : 512
Book Description
A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 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.
Author: Suzanne Parisian
Author: Suzanne Parisian
Author: Fran Hawthorne
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
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Author: United States. Congress. Senate. Committee on Appropriations
Author: deafness
Author: Katherine Eban