In this issue of "Value & Outcomes Spotlight" focused on Regulatory Policy and Real-World Evidence, Ruth Trzcienski, Compliance Director at inVentiv Health, talks about "FDA issues and their involvement with PhRMA and payers. Other articles follow on patient access to medications and assessing the value of medical devices by Claudine Sap├Ęde and Nneka Onwudiwe, respectively."

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