The Reagan-Udall Foundation for the FDA, in collaboration with the 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In November of 2021, the Food and Drug Administration (FDA) issued draft guidance titled Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (Guidance for Industry).

This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. This guidance does not provide recommendations on choice of study design or type of statistical analysis when analyzing data from registries.

FDA issued this draft guidance as part of a series of RWD guidance documents to help satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and to meet a Prescription Drug User Fee Act commitment to issue guidance about the use of RWE in regulatory decision making. 

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Agency considers comments before working on the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by February 28, 2022; more information on submitting comments to the FDA is available here.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.