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US FDA Looks To Standardize Premarketing Safety Assessments

Executive Summary

Ellis Unger tells the Pink Sheet that Premarket Safety Assessment Working Group is overseeing various projects aimed at bringing more standardization to NDA and BLA safety assessments across applications and review divisions, while also bolstering the quality of those reviews; initiatives include development of queries that group similar types of adverse events together and standardizing the safety information requested at pre-NDA meetings.

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