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FDA has a longstanding history of leveraging real-world data RWD, also referred to as real-world evidence RWE, for monitoring and assessing the postmarket safety of approved pharmaceutical products. Historically, RWE was utilized more sparingly to support effectiveness evaluations; however, advancements in RWD avlability and analysis have significantly enhanced its potential for generating robust and meaningful RWE that can inform FDA's regulatory decision-making.
Recognizing this opportunity, FDA is committed to maximizing the utility of fit-for-purpose RWD for the generation of RWE that will drive the development of therapeutic products and enhance regulatory oversight throughout their lifecycle.
Definitions
Real-world data encompass patient health status and healthcare delivery information collected regularly from diverse sources such as electronic medical records, insurance clms databases, disease registries, and other repositories of data capable of reflecting health outcomes.
Real-world evidence represents clinical insights on a product's usage impact - including potential benefits and risks - derived through the analysis of RWD.
The 21st Century Cures Act of 2016 was designed to accelerate the development of medical innovations and expedite their delivery to patients in need. In response, FDA developed a framework in 2018 that outlines how RWE can be used to support approval for new indications under section 505c of the FDC Act or to satisfy post-approval study requirements for drugs.
This framework exts beyond drug and biological products authorized under section 505c, ming to cover biologics licensed under the Public Health Service Act as well.
Across FDA's various centers, RWD and RWE are incorporated into dly operations based on their respective regulatory responsibilities:
For more information about these efforts within CDERCBER, visit this page.
To learn more about how electronic health records EHRs are utilized in clinical research at the Oncology Center of Excellence, see this dedicated webpage.
The Advancing RWE Program is also described here - a commitment related to Prescription Drug User Fee Act VII that emphasizes the integration of RWD and RWE into regulatory decision-making processes for drug approvals.
FDA on various aspects of utilizing RWD and RWE:
Framework for FDA's Real-World Evidence Program
Use of Electronic Health Records in Clinical Studies
Assessing EHRs and Medical Clms Data to Support Regulatory Decisions for Drugs and Biologics
Standards for Data Submissions Contning RWD
Evaluating Registries for Regulatory Decision-Making Purposes
Guidelines on the Integration of Real-World Evidence into Regulatory Processes for Drugs and Biological Products
Tips for Document Submission Utilizing RWE in Drug and Biologics Approval Applications
Considerations for Designing External Control Trials
Integrating Randomized Controlled Trials in Routine Clinical Practice
Incorporation of RWE in Medical Device Evaluation
Role of RWD and RWE in Assessing New Animal Drug Efficacy
A wealth of additional resources are avlable, including:
The Sentinel Initiative - A surveillance system for monitoring drug safety post-market.
The National Evaluation System for health Technology NEST - An effort to evaluate medical devices' performance.
that while this document is accessible online, we recomm visiting the individual center pages or contacting [email protected] directly for more detled inquiries on RWE.
Content last updated: 09192024
Regulated Product Categories
Biological Products
Drugs
Medical Devices
Tobacco Products
Relevant Regulatory Laws and Regulations
21st Century Cures Act of 2016 Cures Act
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FDA Real World Evidence Program Drug Approval with RWE Integration 21st Century Cures Act Compliance EHRs and Medical Claims Data Utilization Regulatory Decision Making Based on RWD Sentinel Initiative for Postmarket Surveillance