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Complete Response Letters Drug Review Policy

Complete Response Letters: US FDA Trying To Identify Subsets For Public Release

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Executive Summary

Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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