FDA Announces 4 Grant Awards for Projects Exploring the Use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making: Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Announces 4 Grant Awards for Projects Exploring the Use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making As part of the agency's real-world evidence (RWE) efforts, the U.S. Food and Drug Administration is announcing four grant awards (RFA-FD-20-020) to examine the use of real-world data (RWD) to generate RWE in regulatory decision-making. Through this awards program, the agency seeks to encourage innovative approaches to further explore the use of RWD while ensuring that scientific evidence supporting marketing approvals meet FDA's high evidentiary standards. As directed by the 21st Century Cures Act, FDA is exploring the potential use of RWD and RWE to support the approval of new drug indications or post-approval study requirements for approved drugs. In December 2018, FDA published a strategic RWE Framework in support of this goal. Read More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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