FDA Issues Draft Guidance on Patient-Focused Drug Development

April 5, 2023 -The U.S. Food and Drug Administration has issued a draft guidance, "Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision- Making." This guidance is the fourth in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making.

This guidance is intended to help clinical trial sponsors in medical product development. The guidance focuses on clinical outcome assessments (COA) issues associated with clinical trial (study) endpoints, design, conduct and analysis and is most relevant to those designing and conducting trials using COAs as well as analyzing and interpreting the trial data.

For more information on the draft guidance and how to submit comments, please see the Federal Register notice here.