Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products December 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2021-D-1146
• 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, was intended to accelerate medical product development and bring innovations and advances 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).   In response to the requirements in section 505F, FDA created a framework for a Real-World Evidence (RWE) Program to evaluate 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 postapproval study requirements.  In the context of this program, this guidance provides considerations for sponsors proposing to design a new registry or use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety.  This guidance does not provide recommendations on choice of study design or statistical methods used to analyze data from registries.

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