GUIDELINE Step 4 Final
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
ABSTRACT — EDITORS' SUMMARY
Selective approach to safety data collection in late-stage trials. Referenced by E6(R3) for proportionate safety data collection.
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PDF · CANONICAL LINK https://www.fda.gov/media/163670/download ↗ RELATED · SAME AUTHORITY