PDUFA VII and the FDA Advancing Real-World Evidence Program: an interview with Lucy Vereshchagina, PhRMA

Following reauthorization of the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII) at the end of September and the FDA’s subsequent launch of the Advancing Real-World Evidence (RWE) Program, we speak with Lucy Vereshchagina, Vice President in Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA) to learn more about these important milestones. Please can you introduce yourself and briefly overview your career? I’m Vice President in Science and Regulatory Advocacy at PhRMA. I joined PhRMA in March 2012 as Senior Director, Scientific & Regulatory Affairs. Before joining PhRMA, I spent over 12...