FDA - Submitting Documents Using Real-World Data and Real-World Evidence

The FDA has issued a new guidance document, titled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.”

This guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format.  FDA will use this information for internal tracking purposes only.  This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license application (BLAs) that contain RWE used to support regulatory decisions regarding safety and/or effectiveness. 

For the purposes of this guidance, FDA defines RWD and RWE as follows: RWD are data relating to patient health status and/or the delivery of health care that are routinely collected from a variety of sources. RWE is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.

For details, see: https://www.fda.gov/media/124795/download

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology