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How To Save A Drug: Iressa’s Return Relied On Consistency Across Totality Of Evidence

Executive Summary

Drug Review Profile of the second life of AstraZeneca’s Iressa shows how FDA adapts to imperfect but improving information without putting undue burden on sponsors – and how the agency recently applied a similar iterative approach to another EGFR inhibitor, Astellas and Genentech’s Tarceva.

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