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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 5, 2022

July 29, 2024

Center for Drug Evaluation and Research

1c6ec306-023c-4065-80cd-a01e6993d76b

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