Skip to main content
eScholarship
Open Access Publications from the University of California
Refine Search

UC Comment Letters

UC Office of the President

UC Comments on FDA's Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability (Docket No. FDA-2021-D-1214, December 9, 2021)

Abstract

This comment letter responds to the FDA’s draft guidance on the use of real-world data and real-world evidence to support regulatory decision-making for drugs and biological products. UC recommends clarifying that certain non-interventional studies using existing real-world data do not require IRB review and further aligning FDA requirements with the Common Rule by permitting appropriate exemptions from IRB review for minimal-risk research, thereby reducing administrative burden while maintaining human-subject protections.


Top