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Nov 6, 20232 min read

USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation

Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...

Apr 5, 20231 min read

USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision

Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...