FDA Invites Public Comments on Real-World Evidence (RWE) Program Draft Guidance for Non-Interventional Studies

The Food and Drug Administration (FDA) is inviting comments on a draft guidance regarding the Real-World Evidence (RWE) Program. The deadline for submitting comments is June 20, 2024. According to 21 CFR 10.115(g)(5), comments can be made on any guidance at any time, but to ensure that the FDA considers your comment on a draft guidance, it is recommended to submit either online or written comments before the deadline. If submitting written comments, they can be mailed to the Dockets Management at the Food and Drug Administration.

The RWE Program is a series of guidance documents aimed at providing clarity on how real-world evidence can be used in regulatory decision-making. The draft guidance under this program is identified by the docket number FDA-2023-D-5470 and was issued by the Guidance Issuing Office, including the Oncology Center of Excellence, Center for Biologics Evaluation and Research, and Center for Drug Evaluation and Research. This guidance is intended to fulfill a mandate under the FD&C Act to provide guidance on the use of RWE in regulatory decision-making.

The draft guidance contains recommendations for sponsors who are considering submitting a non-interventional study, also known as an observational study, to FDA to demonstrate substantial evidence of effectiveness and/or evidence of safety of a drug. This guidance was created in response to stakeholders’ interest in using non-interventional studies to support the effectiveness or safety of drugs. The draft guidance is current as of March 19, 2024.