FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PATIENT-LEVEL DATA FOR DRUGS AND BIOLOGICAL PRODUCTS SUBMISSIONS CONTAINING REAL-WORLD DATA AND REAL-WORLD EVIDENCE; REQUEST FOR INFORMATION

WASHINGTON, Nov. 12 -- Food and Drug Administration has issued a notice called: Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence; Request for Information.

The notice was published in the Federal Register on Nov. 12 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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...