US FDA's Patient Experience Data Guidance Calls More Attention To Burdens Of Surveys

New language in the final version of a US Food and Drug Administration guidance on patient-focused drug development emphasizes a more patient-centric view about the burdens of collecting survey data, and ensuring such questions are accessible to those with disabilities and in a culturally appropriate language.

The guidance, “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients,” is the second in a series of four methodological documents on collection and submission of patient experience data and other relevant information to be used for medical product development and regulatory decision-making. The guidances were required under the 21st Century Cures Act and the sixth iteration of the prescription drug user fee program (PDUVA VI)