Event

The US Food and Drug Administration (FDA) has drafted a fourth Patient-Focused Drug Development (PFDD) guidance document which focuses on “Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making.” The FDA has developed four guidance documents to inform the inclusion of patient experience when developing new medical therapies and products. The PFDD guidance documents are anticipated to be influential in the field of health economics and outcomes research.

In part 1 and 2 of this webinar series, patient representatives and FDA staff presented on the first 3 finalized guidances. In part 3 of the webinar series, an overview of the draft guidance 4 document will be provided including the methods, standards, and technologies for collecting and analyzing clinical outcome assessment (COA) data. Guidance document 4 was recently released and is open for comments. With the public comment period open until July 2023, this webinar will also present ISPOR members with the opportunity to ask questions and provide comments that will help inform ISPOR’s response on the draft guidance 4 document.

Speakers will include an FDA representative to inform on draft guidance 4 and Richard Willke, ISPOR's Chief Science Officer, who will address ISPOR's role and response to the document.

The draft guidance 4 titled “Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making” can be accessed here. In case you missed it, webinar part 1 and part 2 of the series are available on-demand.

Monica Morell, PhD, Statistician, Patient-Focused Statistical Support Team, Division of Biometrics III, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), US FDA, Silver Spring, MD, USA

Richard Willke, PhD, Chief Science Officer, ISPOR, Lawrenceville, NJ, USA

Reservations are on a first-come, first-served basis.