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# Real-World Data, Evidence Guidance Explained
- URL: https://www.fdaweb.com/real-world-data-evidence-guidance-explained/
- Published: 2019-06-11T12:00:00.000Z
- Updated: 2026-09-15T01:32:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144311

CDER Office of Medical Policy health science policy analyst **Lauren Milner** says a new agency draft guidance on submitting documents using real-world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics is needed because the availability of such data and evidence has created interest within research and medical communities to enhance clinical research and support regulatory decision-making. In an agency [Webinar](https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biologics-overview?utm%5Fcampaign=SBIA%3A%20Recorded%20Webinar%20Submitting%20RWE&utm%5Fmedium=email&utm%5Fsource=Eloqua) on the draft, Milner also said the 21st Century Cures Act requires the agency to establish a program to evaluate potential use of RWE to **(1)** help support approval of new indications for approved drugs, and **(2)** help support or satisfy postapproval study requirements.

“CDER and CBER intend to identify and track certain types of submissions using RWE to inform FDA’s RWE program under the Cures Act and to help FDA understand the scope and use of RWE submitted to support regulatory decisions regarding safety and/or effectiveness,” Milner said. She said the agency hopes the draft guidance will help maintain a dialog and mutual learning with external stakeholders on their individual efforts in RWE.

According to Milner, the draft is intended to encourage sponsors and applicants who are using RWD to generate RWE as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. The guidance applies to submissions under INDs, NDAs, and BLAs.