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systems of regulation and liability operate complementarily. The question is why two legal tools that are meant to achieve and … between the two. At present we have two separate sets of rules that operate independently: pre-marketing regulation with post …
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manufacturer) on pharmaceutical regulation in a North-South framework with a firm's endogenous decision to export to the South … via reimbursement limits. Parallel trade may relax regulation in the source country of parallel imports (South) and … intensify regulation in the destination country (North): In the source country, parallel trade may relax regulation both under a …
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The U.S. Food and Drug Administration (FDA) balances risks and benefits before approving pharmaceuticals, as rationality would require. But powerful behavioral biases that lead to the mishandling of uncertainty also influence its approval process. The FDA places inordinate emphasis on errors of...
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In this article we analyse the market for drugs in health care markets where third payers (an insurance company or a government agency) bear the cost and we suggest a common and transparent methodology to set the price for new drugs as well as active principles for which an alternative already...
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