Posted by Michael Wonder on 08 Dec 2016
Real world evidence — what is it and what can it tell us?
7 December 2016 - The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.
Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, writing alongside FDA Commissioner Robert Califf and Janet Woodcock, director of the Center for Drug Evaluation and Research, begin their piece by taking a step back and calling the meaning of the term RWE “elusive.”
