7-9 March 2023
To facilitate FDA’s internal tracking of submissions that include real-world data (RWD) and real-world evidence (RWE), the agency published a guidance on how to identify the use of RWD / RWE in submission cover letters. The cover letter should describe the purpose of using RWD / RWE, types of study designs that include RWD / RWE, and RWD sources used to generate RWE. The guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that contain RWD / RWE intended to support a regulatory decision regarding product safety and / or effectiveness.
According to the FDA,
Examples of study designs that may be included in regulatory submissions are:
The agency recommends that sponsors and applicants not identify submissions that contain RWD / RWE if those data are not intended to support product labeling. For example, submissions using RWD only to generate hypotheses or to plan a clinical trial (e.g., to identify potential trial participants), studies incorporating RWD only in exploratory modeling or simulations, studies using RWD only to validate an endpoint, or studies using RWD only in the qualification process for Drug Development Tools should not be identified in submissions to FDA.
More information is available in FDA´s guidance document Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products.