Zdrowie i gospodarka · 27/10/2017

FDA Announces Public Workshop to Inform Patient-Focused Drug Development Guidance

The FDA is hosting a public workshop to discuss methodological approaches for collecting patient experience data to inform regulatory decision-making, with the goal of developing patient-focused drug development guidance as required by the 21st Century Cures Act and the Prescription Drug User Fee Act (PDUFA VI). The workshop will provide an opportunity for stakeholders to share their input and experiences with data collection methods.