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Notice2022-22795

Advancing Real-World Evidence Program

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
October 20, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the Advancing Real-World Evidence (RWE) Program to fulfill FDA's commitment under the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022.

Indexed from Federal Register on October 20, 2022.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.