Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research
In accordance with PDUFA VII reauthorization commitments, the FDA is reporting aggregate and anonymized data regarding submissions containing Real-World Evidence (RWE) to both CBER and CDER.
Sponsors and manufacturers submitting drug and biologic applications that utilize Real-World Evidence to support regulatory decisions.
This reporting initiative indicates a formalization of how the FDA tracks the utility and frequency of RWE in the regulatory lifecycle. For industry professionals, this suggests that RWE is becoming a standardized component of the submission landscape, necessitating robust data collection and anonymization protocols. The transparency provided by aggregate reports may eventually offer insights into which therapeutic areas or submission types are successfully leveraging RWE.
Regulatory and clinical teams should continue to document RWE methodologies clearly in submissions, as these will likely be subject to the FDA's internal aggregate tracking and reporting under PDUFA VII commitments. Data management teams should ensure RWE datasets are structured to facilitate reviewer assessment.
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
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