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# Real-World Evidence Regulatory Guidance
- URL: https://www.fdaweb.com/real-world-evidence-regulatory-guidance/
- Published: 2023-08-30T12:00:00.000Z
- Updated: 2026-09-14T18:53:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155207

FDA has published a guidance, *Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products*, to discuss the applicability of the IND regulations to various clinical study designs that use real-world data (RWD). The [document](https://www.fda.gov/media/171667/download?ref=fdaweb.com) also clarifies the agency’s expectations concerning clinical studies using RWD submitted to FDA in support of a regulatory decision on the effectiveness and safety of a drug, as part of an NDA or BLA. The guidance focuses primarily on clinical study designs that are non-interventional.

FDA says issuing the guidance partially fulfills a Federal Food, Drug, and Cosmetic Act (FFDCA) mandate to issue a guidance about using real-world evidence to help support approval of a new indication for a drug already approved under Section 505(c) of the FFDCA or to help support post-approval study requirements.