The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), is hosting a series of free, public webinars for FDA-issued guidance related to real-world data (RWD) and real-world evidence (RWE). Webinar attendees will have an opportunity to hear from the FDA during the session as well as submit questions when registering for the webinar. 

In December 2021, the FDA issued draft guidance titled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.”

This guidance discusses the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize RWD and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug (e.g., as part of a new drug application or a biologics license application) that are not subject to the IND regulations. 

FDA issued this draft guidance as part of a series of documents to help satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE to help support approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support post-approval study requirements.

To ensure that the Agency considers comments before working on the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by March 8, 2022; more information on submitting comments to the FDA is available here. 

For more information and to register please visit the event page on the FDA Foundation website.