FDA spells out how to use clinical outcome assessment measures in patient-focused drug development

FDA guidance published late last month aims to help stakeholders incorporate patient experience data through the use of clinical outcome assessment measures.

As part of its initiative to support patient-focused drug development, the agency published draft guidance June 29 on how to incorporate clinical outcome assessments (COAs) into endpoints for regulatory decision-making. The document is the third in a series of four guidances on PFDD. ...