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oversight of imported food. The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by …Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million … illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and …
Persistent link: https://www.econbiz.de/10014181189
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Governments and firms often use committees of experts to help them make complexdecisions, but conflicts of interest could bias experts' recommendations. We focus on whetherfinancial ties to drug companies bias FDA drug advisory committee (AC) members' voting ondrug approval recommendations. We...
Persistent link: https://www.econbiz.de/10012934325
government's legislative powers. With trials and marketing of compounds and pharmaceuticals carried out in different countries …
Persistent link: https://www.econbiz.de/10014213862
of the Food and Drug Administration that the drug is both safe and effective. Congress approved this requirement in 1962 … at the heart of the safe and effective regulatory promise. We locate in the Food, Drug and Cosmetic Act an obligation for …
Persistent link: https://www.econbiz.de/10014058315
sound regulation meant to protect and accurately inform consumers and not just respond to consumer demand, food regulation …, consumers increasingly make choices not necessarily based on the nutrition label, but on other messages and labels on food, such … expectations leading to consumer deception. The deception may be caused by a shift from regulating food products to regulating the …
Persistent link: https://www.econbiz.de/10014137541
Persistent link: https://www.econbiz.de/10000619953
regulation. The growing public-private partnerships in research and drug development and their impact on the regulatory control … of pharmaceuticals are in this context the target of much criticism. Ensuring the safety and efficacy of pharmaceuticals … pharmaceutical products to illustrate this point. We also describe how drug regulation in Canada is connected to other domestic and …
Persistent link: https://www.econbiz.de/10012752017
Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective … been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug … innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively …
Persistent link: https://www.econbiz.de/10012754003
The U.S. Food and Drug Administration (FDA) balances risks and benefits before approving pharmaceuticals, as …
Persistent link: https://www.econbiz.de/10014148944