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USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Oncology Center of Excellence (OCE) published final guidance on "Submitting Documents Using Real-World Data and Real World Evidence to FDA for Drug and Biological Products".

FDA defines Real-World Data (RWD) and Real World Evidence (RWE) as:


RWD is data relating to patient health status and/or the delivery of health care that is routinely collected from a variety of sources. Eg: Electronic health record (EHR) data


RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD.


This guidance focuses on submissions to FDA that rely on RWD/RWE to support a regulatory decision regarding product effectiveness and/or safety. An IND application, a meeting request, a study protocol, and a final study report are examples of relevant submission types.


The guidance contains a table that represents an example of how sponsors and applicants can identify a submission containing real-world data (RWD)/real-world evidence (RWE) as part of their cover letter accompanying such submissions to FDA.


Click on this LINK to know more about Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products.



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