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        Science and Research Special Topics

Real-World Evidence

                        
                Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence Home
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          Science and Research Special Topics
          Real-World EvidenceScience and Research Special Topics Real-World Evidence
  	
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    PrintFDA 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.

Definitions

**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.

Multiple FDA centers incorporate RWD and RWE into daily activities based on the nature of their work and the scope of their regulations:

See CBER/CDER page for more information.

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.

**Selected Guidance**

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 DrugsOther Resources

Sentinel Initiative
	National Evaluation System for health Technology (NEST)
	Digital Health Technologies (DHTs) for Drug Development**Contact Information**

For more information on RWE, please visit the individual Center pages or contact CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov.

                                                                                  Content current as of:
      02/05/2023
                  
                   
Regulated Product(s)
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			     			  			     TobaccoLaw(s) & Regulation(s)
			  21st Century Cures Act of 2016Real-World Evidence                
                          

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