US FDA Looks To Standardize Premarketing Safety Assessments
US FDA Looks To Standardize Premarketing Safety Assessments
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A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.
Publisher: Pinksheet
- Description
Pink Sheet spoke with Ellis Unger of the Premarket Safety Assessment Working Group at the United States Food and Drug Administration who says the group is overseeing projects aimed at bringing more standardization to NDA and BLA safety assessments across application and review divisions. Standardizations that could bring changes to how sponsors classify clinical trial adverse events and the types of information companies routinely are asked to submit to the agency. Unger says the initiative started in January 2017 and is part of the Center for Drug Evaluation and Research’s broader effort to modernize the new drug review process.
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