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On May 4, 2023, the U.S. Food and Drug Administration (FDA) is hosting a webinar for patients, industry, and other interested stakeholders to discuss and answer questions about the draft guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making.

Webinar Materials:

This webpage will be updated as webinar materials are developed.

Background:

Guidance 4 is the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

Guidance 4 focuses on methods, standards, and technologies for collecting and analyzing COA data, including selecting COA-based endpoints and determining clinically meaningful differences in these endpoints.

Public Docket:

Interested stakeholders are invited to submit comments on the draft guidance to the public docket. The public docket will close on July 5, 2023.

Related Information:

CDER Patient-Focused Drug Development