Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry August 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2021-D-1214
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Oncology Center of Excellence

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this section, FDA created a framework for a program (RWE Program) to evaluate the potential use of real-world evidence (RWE) in regulatory decision-making.

FDA is issuing this guidance as part of its RWE Program to satisfy, in part, the mandate under section 505F of the FD&C Act to issue guidance about the use of RWE to help support approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support postapproval study requirements.

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