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BioPharmaceutical Regulation

FDA Talking To Industry About Releasing “Complete Response” Letters

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Commissioner Hamburg says conversations are underway with industry to allow the agency to release its reasons for not approving a product, in part so others will not waste funds repeating known failures. FDA is also working to remove user fee revenue from sequestration.

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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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