The FDA is continually publishing and updating guidance to allow for and encourage the generation of RWE specifically for regulatory decisions. Recently they issued new guidelines for industry: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products in August 2023.

These guidelines cover the incorporation of RWE in both pre- and post-market regulatory decisions regarding the effectiveness and safety of a drug and focus primarily on non-interventional studies. 

Click here to download our quick visual summary of the resources referenced in that guidance.