US FDA Guidance On Endpoints Incorporating Clinical Outcome Assessments Fulfills Patient-Focused Commitment

 
• By Bridget Silverman

Stakeholders can weigh in during 4 May 2023 webinar as US FDA rounds out a PDUFA VI commitment with a draft of the fourth of four methodological guidances on patient-focused drug development.

Doctor woman sitting with male patient at the desk
• Source: Shutterstock

The growing uptake of patient experience data in clinical development programs is reflected in the fourth of four methodological guidance document on patient-focused drug development, a draft guidance on “Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making” that touches on a wide range of issues and considerations that have arisen in the course of the maturation of patient-focused drug development from a set of goals to an increasingly established aspect of new drug applications.

The new PFDD document poses situations and points to consider drawn from the FDA’s experience with patient experience data in...

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