Real-World Data Webinar Series:
Data Standards for Drug and Biological Product Submissions Containing Real-World Data – Draft Guidance for Industry
Friday, December 3, 2021
1:00-2:00 pm Eastern
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). 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In October 2021, the Food and Drug Administration (FDA) issued draft guidance titled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data."
This guidance provides recommendations to sponsors for complying with section 745A(a) of the Federal Food and Drug, and Cosmetic Act (FD&C Act) when submitting real-world data (RWD) as study data in applicable drug submissions using standards specified in FDA’s Data Standards Catalog.
FDA issued this draft guidance as part of a series of “RWD" guidance documents to help satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and to meet a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 RWD 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Agency considers comments before working on the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by January 21, 2022; more information on submitting comments to the FDA is available here.