FDA outlines Advancing RWE pathway, reviews guidance and submission pitfalls At an FDA Grand Rounds, Dr. Marie Bradley described the Advancing Real World Evidence pathway (launched under PDUFA VII), guidance development, common reasons RWE submissions fail, and operational advice for sponsors seeking early consultation.

Dr. Marie Bradley reveals critical insights on the FDA's new Advancing Real World Evidence pathway, sharing essential guidance for sponsors to avoid common submission pitfalls.

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