A Public Webinar
Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry

 

November 4, 2021

1:30-2:30 pm ET

In September, 2021, the Food and Drug Administration (FDA) issued draft guidance titled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products."

FDA issued this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to help satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to meeting a Prescription Drug User Fee Amendments goal to issue guidance about the use of RWE in regulatory decision making. This draft guidance is intended to provide sponsors, researchers, and other interested stakeholders with recommendations when proposing to use data from electronic health records (EHRs) or medical claims data in clinical studies to help support a regulatory decision for effectiveness or safety.

This event is part of a series of webinars hosted by the Reagan-Udall Foundation for the FDA, in collaboration with the FDA. Attendees will have an opportunity to hear from the FDA during the session as well as submit questions when registering for the webinar.

To ensure that the Agency considers comments before working the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by November 29, 2021; more information on submitting comments to the FDA is available here.

Read the draft guidance

This webinar is part of a series hosted by the Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food and Drug Administration (FDA). This series is supported by the FDA of the U.S. Department of Health and Human Services (HHS) as part of an award of $56,097 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.