The Food and Drug Administration (FDA or Agency), is announcing a request for information (RFI) from interested parties to share perspectives on patient-level data access related to the use of real-world evidence (RWE) in regulatory decision-making for drugs and biological product submissions. The purpose of this RFI is to solicit input from interested parties on innovative solutions to address the challenges in submitting patient-level data for real-world data (RWD) analyzed in clinical studies included in a marketing application. Interested parties may include regulated industry, health information technology (HIT) vendors, academic medical centers, electronic data capture vendors, patient advocates, and other interested parties.
← Back