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.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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