2022-19494: Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drug and Biological Products; Guidance for Industry; Availability
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products." To facilitate FDA's internal tracking of submissions to the Agency that include real-world data (RWD) and real- world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA's substantive review of the RWD/RWE submitted as part of the Agency's standard review process. This guidance finalizes the draft guidance entitled "Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics" issued on May 9, 2019.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →