FDA Guidance — RWD/RWE
The CDER/CBER Real-World Evidence guidance trail from the foundational 2018 framework through the 2024 EHR & claims data guidance, plus the May 2019 submission-identification draft.
- 2024· Final guidance
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
Guidance on evaluating EHR and medical claims data for use in clinical studies intended to support drug and biologic regulatory decisions.
Open on FDA.gov ↗ - 2023· Final guidance
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
General considerations guidance covering how FDA thinks about clinical studies that use RWD and produce RWE.
Open on FDA.gov ↗ - 2023· Final guidance
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
Registry-focused guidance for sponsors proposing new or existing registries in regulatory settings.
Open on FDA.gov ↗ - 2022· Final guidance
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
Final version of the submission-identification guidance for INDs, NDAs, and BLAs containing RWD/RWE intended to support a regulatory decision.
Open on FDA.gov ↗ - 2019· Draft guidance (May 2019)
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
The May 2019 draft focused on helping sponsors identify RWD/RWE-containing submissions so FDA could track them internally.
Open on FDA.gov ↗ - 2018· Framework
Framework for FDA’s Real-World Evidence Program
Foundational FDA framework explaining how CDER and CBER would evaluate RWE for drugs and biologics under the RWE Program.
Open on FDA.gov ↗