Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

On 16 June 2020 the FDA announced the availability of the final guidance for industry, FDA staff, and other stakeholders.

This guidance is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents that FDA is developing to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.