While vaccination rates have soared and cases of preventable infections have plummeted, an increasingly vocal cross section of Americans have questioned the safety and necessity of vaccines. In Vaccine Nation, Elena Conis explores this complicated history and its consequences fo…
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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 syst…
"This book 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, q…
"Government regulation of toxic substances varies dramatically between the United States and Canada. In Risk, Science, and Politics Kathryn Harrison and George Hoberg analyse these differences and evaluate the strengths and weaknesses of two very different regulatory styles." "T…
Declining health standards and the threat of infectious disease outbreaks have raised questions about China's internal transition: why did the same reform-induced dynamics produce an economic miracle, but fail to reproduce the same success in the health sector? This book examine…
The lack of significant improvement in people's health status and other mounting health challenges in China raise a puzzling question about the country's internal transition: why did the reform-induced dynamics produce an economic miracle, but fail to reproduce the success Mao h…
"The AIDS epidemic has posed more urgent historical questions than any other disease of modern times. How have societies responded to epidemics in the past? Why did the disease emerge when and where it did? How has it spread among members of particular groups? And how will the p…
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 th…