martes, 30 de abril de 2024

E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials

https://www.fda.gov/media/177957/download?attachment=&utm_medium=email&utm_source=govdelivery E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials DECEMBER 2022 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e19-selective-approach-safety-data-collection-specific-late-stage-pre-approval-or-post-approval?utm_medium=email&utm_source=govdelivery CDER Center for Clinical Trial Innovation (C3TI) https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti?utm_medium=email&utm_source=govdelivery

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