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Praise For INSIDE THE FDA
"A clear-eyed, thoughtful look at an agency that regulates a quarter of the U.S. economy and, more than any other, has the safety of the American public in its hands. Inside the FDA makes plain how powerful and controversial the Food and Drug Administration has become. People seeking to understand the government's role in health care and the biotech revolution would be wise to read Ms. Hawthorne's book."
—Elizabeth MacBride Health-care writer and former managing editor of Crain's New York Business
"Controversy lives on the FDA's doorstep, and it knocks loudly— as it did recently with Vioxx—when a drug it approves is involved in consumer deaths. Fran Hawthorne has written a vivid and compelling account of the pressures from politicians, industry, and consumers; the scientific uncertainties; the risk-reward compromises; and the constantly changing legal landscape that influences the agency's life-and-death decisions. Since these pressures are not likely to diminish, it is all but inevitable that another Vioxx will slip past the scientists of this powerful, public-spirited but imperfect institution."
—Clem Morgello Former senior editor and columnist at Newsweek, and former senior editor at Dun's Review
Praise for The Merck Druggernaut
"[Hawthorne] understands and communicates the incredible complexity of discovering new drugs and introducing them to the market."
—The New York Times
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Chapter One: Case Study - Chasing Cancer.
Chapter Two: Beyond Science.
Chapter Three: The First 100 Years.
Chapter Four: “You Don’t Know Which Agency Is in Charge”.
Chapter Five: Truckloads of Paper.
Chapter Six: Case Study – The Return of Thalidomide.
Chapter Seven: How Picky Is the FDA?
Chapter Eight: How Powerful Is Industry?
Chapter Nine: Case Study — The Death of Monica George.
Chapter Ten: When Consumers Get Angry.
Chapter Eleven: A Political Pawn.
Chapter Twelve: FDA and DNA.
Chapter Thirteen: The FDA Meets Madison Avenue.
Chapter Fourteen: Frivolous Drugs?
Chapter Fifteen: The Next 100 Years.
Posted August 19, 2012
Posted June 12, 2006
Posted September 18, 2005
'Inside the FDA' is a thoughtful, balanced, and well-researched look inside the controversial and troubled Food and Drug Administration. Author Fran Hawthorne is an experienced business journalist and her skills are evident here. Digging into the FDA's complex and conflicting world, the book provides an informative picture of FDA's bureaucratic, political, and scientific drivers. Ms. Hawthorne does an excellent job of laying out what the FDA is suppose to do, what is really does, and where and why it fails. It makes for a great read.Was this review helpful? Yes NoThank you for your feedback. Report this reviewThank you, this review has been flagged.
Posted May 7, 2012
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