GUIDANCE DOCUMENT
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry Draft Guidance for Industry November 2021
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2021-D-1146
- Docket Number:
- FDA-2021-D-1146
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchOncology 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, the Food and Drug Administration (FDA) created a framework for a Real-World Evidence (RWE) Program to evaluate the potential use of real-world evidence 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.