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Epidemiology guidance

Executive Summary

FDA is considering developing a guidance on the use of epidemiological data in order to facilitate post-marketing surveillance. The document would advise industry on the analysis of large safety databases. The expansion of funding for post-market drug surveillance activities is under discussion as part of the fourth renewal of the Prescription Drug User Fee Act next year (1"The Pink Sheet" Nov. 21, 2005, p. 3)...

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