FDA has a long history of using what we currently call real-world data (RWD) and real-world evidence (RWE) to monitor and evaluate the postmarket safety of approved drugs. RWE has also been used historically to support effectiveness, but on a more limited basis. Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support FDA regulatory decisions.
FDA is committed to realizing the full potential of fit-for-purpose RWD to generate RWE that will advance the development of therapeutic products and strengthen regulatory oversight of medical products across their lifecycle.
Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.
Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.
FDA’s RWE Activities
The 21st Century Cures Act of 2016 was designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them. In response, FDA created a Framework in 2018 for evaluating the potential use of RWE to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support or satisfy drug post-approval study requirements. In addition to drug and biological products approved under section 505(c), this framework is also intended for application to biological products licensed under the Public Health Service Act.
See OCE RWE page for information on RWD and RWE at the Oncology Center of Excellence.
See Advancing RWE Program page for information describing one of the Prescription Drug User Fee Act VII commitments related to RWE.
- Framework for FDA’s Real-World Evidence Program
- Use of Electronic Health Records in Clinical Investigations
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products
- Data Standards for Drug and Biological Production Submissions Containing Real-World Data
- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
- Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
- Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
- Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
- Sentinel Initiative
- National Evaluation System for health Technology (NEST)
- Digital Health Technologies (DHTs) for Drug Development
For more information on RWE, please visit the individual Center pages or contact CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov.