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- W2000669270 abstract "Drug registration is an interactive process between regulatory authorities and sponsor, resulting in a decision. Contrary to common belief, it is not a stand-alone judgement made at a given time point by these regulatory authorities. In the planning of trials aimed at supporting a Marketing Authorization Application, multiple contacts and interactions between sponsor and regulatory authorities can occur, mostly through requests for scientific advice. The final opinion coined by the Committee for Medicinal Products for Human Use of the European Medicines Agency also derives from extensive discussions with sponsors." @default.
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- W2000669270 date "2008-02-01" @default.
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- W2000669270 title "Open-label trials and drug registration: a European regulator’s view" @default.
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- W2000669270 doi "https://doi.org/10.1111/j.1538-7836.2008.02835.x" @default.
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