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  1. Real-World Evidence

Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research

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) that contain real-world evidence (RWE). 
 
The goal of this reporting is to describe submissions to FDA containing real-world data (RWD) to generate RWE intended to support or that supported regulatory decision-making about a drug or biological product’s effectiveness or safety. This report is not intended to include all submissions to FDA containing analyses of RWD. To be included in the report, submissions must meet at least one criterion from each category below:

  • Type of Regulatory Submission    
    • Initial protocol submissiona
    • Protocol amendment that adds RWD to a study that did not previously include RWD
    • New drug application (NDA) (original or supplemental)
    • Biologics license application (BLA) (original or supplemental)
    • Final study report to satisfy a postmarketing requirement (PMR) or postmarketing commitment (PMC)
       
  • Role of Studyb     
    • Serve as an adequate and well-controlled study to support effectiveness
    • Serve as confirmatory evidence for approval based on a single adequate and well-controlled study 
    • Provide safety data necessary for approval of an NDA or BLA
    • Satisfy a PMR or PMC
       
  • Contribution of Real-World Data
    • Data for primary endpoint assessment
    • Data for external control arm
    • Safety data necessary for approval of an NDA or BLA or to satisfy a PMR or PMC

See CBER page for information on submissions to CBER containing RWE.

See CDER page for information on submissions to CDER containing RWE.

For more information on FDA’s Real-World Evidence program, see Real-World Evidence or contact CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov.

  • aSubmission of an interventional study protocol to an IND or submission of a non-interventional study protocol to an existing IND or to a pre-IND.  
  • b“Role of study” may be as intended by the sponsor or applicant (e.g., at the time of protocol submission, sponsor intends for the study to serve as an adequate and well-controlled study) or as determined by FDA (e.g., study served as confirmatory evidence for approval of an NDA or BLA).
 
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