CONTEXT: This is a great article on just how valuable RWR / RWE is becoming for regulators worldwide as they will invariably follow the FDA’s lead | Be honest if the number of product approvals with RWE as a key part of the submission surprised you, not to mention the variety of ways in which the data is used, from nesting prospective RCTs within RWD sources to control rms for novel devices| The future is here and it’s Real!
IMPACT: High
READ TIME: 5 mins
Quality Level Mean [1 – 10]: 9
1. “FDA has published an analysis of 90 examples of the use of real-world evidence (RWE) to support regulatory decision making.”
2. “That experience has persuaded FDA to try to encourage more use of RWE by sharing examples of its successful application.”
3. “FDA also addresses the use of RWE in two humanitarian device exemptions filings.”
4. “FDA cited the use of RWE as the primary source of clinical evidence and the nesting of prospective, randomized trials within real-world data sources (RWD) as examples of how applicants used the evidence.”
5. “Jeff Shuren, CDRH director, and Daniel Caños, director of the center’s Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, set out how RWE use has benefited FDA and the groups it serves in a blog post.”
Source URL: https://www.medtechdive.com/news/fda-real-world-evidence-use-abbott-medtronic/596846/