08/08/2023
Photo by John Adams on Unsplash
The US Food and Drug Administration (FDA) recently updated their website to include a Frequently Asked Questions pageequently Asked Questions page for their Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program was announced in October 2022 and is intended to support new labeling claims, a new indication for an approved drug, or to satisfy post approval requirements. The Program was an FDA commitment under PDUFA VII, approved as part of the FDA User Fee Reauthorization Act of 2022. RWE provides valuable information on the safety and efficacy of a product when it is used as intended, outside the constraints of a clinical trial.
One of the goals of the Advancing RWE Program is to help sponsors know how to generate RWE to support new labeling claims or new indications for approved products, or to meet post approval requirements, while complying with regulatory requirements. Sponsors are selected for the Program and meet with the FDA early in the process before protocol development. Sponsors can submit requests to be included in the Program, but spots are limited. Considerations for the Program include the potential adequacy of the study design, if data is fit for purpose, and if diversity is promoted (e.g., indications, data sources, study designs, etc.). The Program is optional.
The FAQ page was added after the FDA reviewed questions received during the first submission cycle. It is expected that additional questions with answers will be added. Some questions of note are:
Question 1 summary: Is participation in the Advancing RWE Program limited to already approved products?
Answer 1 summary: It is likely that products that have not been approved would not have enough RWE to support effectiveness.
Question 2: “Are RWE proposals intended to support the approval of a medical device eligible to participate in the Advancing RWE Program?”
Answer 2 summary: The Program is open for products that fall under PDUFA and therefore not applicable for medical devices.
The following RWE blogs go into more detail about the history of RWE including the 2018 FDA Framework for RWE developed in response to the requirement in the 21st Century Cures Act, which intended to encourage advancement and innovation to the clinical trial landscape.
For more information on the FDA’s framework for RWE, visit our blog “FDA Framework for Use of Real-World Evidence.”
In September 2021, the FDA published a draft guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products.” Read our blog HERE for more information.
In October 2021, the FDA published a draft guidance “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” Read our blog HERE for more information.
In December 2021, the FDA published a draft guidance “Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.” Read our blog HERE for more information.
In September 2022, the FDA released a final guidance “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products” Read our blog HERE for more information.
- The Clinical Pathways Team
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