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BioPharmaceutical United States Approvals

Estimated FDA User Fee Review Goals For Pending NDAs/BLAs

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Estimated user fee goals for FDA action on publicly disclosed NDAs, BLAs and efficacy supplements are calculated based on the date of receipt and assignment to standard or priority review. Resubmissions with significant new data or analyses have a 6-month goal. FDA may extend review goals.

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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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