Drugs

RWD, RWE Submission Guidance

FDA has published a final guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products, encouraging sponsors and applicants to identify in their submission cover letters certain uses of real-world data (RWD) and real-world evidence (RWE). The document says that following the recommendations will facilitate FDA’s internal tracking of submissions that contain RWD and RWE.

The guidance does not address the agency’s substantive review of the RWD/RWE submitted as part of the standard review process, FDA says. It applies to submissions for INDs, NDAs, and BLAs that contain RWD/RWE intended to support a regulatory decision about product safety and/or effectiveness.

For purposes of the guidance, FDA defines RWD as data relating to patient health status and/or health care delivery that are routinely collected from sources such as electronic health record data, medical claims data, product or disease registry data, data obtained from digital health technologies, and data gathered from other sources that can inform on health status such as questionnaires. It defines RWE as the clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome