Latest News
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5 February 2013
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A new paper published in the journal Clinical Pharmacology & Therapeutics by two of the US Food and Drug Administration's (FDA) top drug regulatory officials argues that the market seems unable or
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Regulatory Update
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9 July 2012
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The European Commission adopted a Decision on 6 July to establish an independent expert panel to advise the Commission on “effective ways” to make Member State healthcare systems economically
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Latest News
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20 April 2012
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Draft legislation to reauthorize a number of bills funding the US Food and Drug Administration (FDA) through user fees includes a provision to add economic considerations to the agency’s mission,
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In Focus
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1 November 2011
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This month’s theme is economics and regulatory strategy. Although it is still common for many regulatory professionals to be concerned only with the pure scientific/regulatory side of their work, as the profession has evolved over the years, the ambit of advice they provide has expanded—and with it, their need for knowledge of the entire product lifecycle, from the glimmer in an inventor’s eye, through research, trials, approval and even marketing. Many of these stages require an eye to the economics of product development, launch and even postmarket events.
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