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Hamburg Details Some Sequestration Impact On FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Commissioner says allowing the sequester would slow implementation of FDASIA provisions and reduce some overseas inspections.

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With the implementation of across-the-board spending cuts, FDA will be unable to add the hundreds of new employees needed to meet the goals of user-fee and other programs, a paucity that could damage the agency for years to come.

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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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