FDA Patient-Focused Drug Development (PFDD) Guidance - Part 2

March 7, 2023

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Title: FDA Patient-Focused Drug Development (PFDD) Guidance - Part 2

Tuesday, March 7, 2023
9:00AM EST | 2:00PM UTC | 3:00PM CET

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Please join us for the second webinar of this two-part webinar series. The FDA is developing Patient-Focused Drug Development (PFDD) guidance documents to inform the inclusion of patient experience when developing new medical therapies and products. This webinar series highlights the four methodological guidance documents, which includes two finalized guidances (1 and 2), a draft guidance (3), and guidance that is under development (4.) The PFDD guidance documents are anticipated to be influential in the field of health economics and outcomes research. In this webinar series, we will hear from patient representatives and FDA staff to learn what is covered in this guidance series and what these new guidances mean for patient-focused drug development and the HEOR community.

Learning Objectives

• Inform the ISPOR membership about the FDA PFDD initiative in general, the four PFDD guidance documents more specifically, and the various ways PFDD might impact the work they do in HEOR, clinical outcome assessments (COA), regulatory science, and other areas.
• Discuss draft guidance 3, for which a public comment period was recently conducted, and what is required in guidance 4.  
• Provide insights on how the guidance documents can be used.
• Provide insights on the future of PFDD.

It is suggested to review these resources prior to participating in the webinar.

Click here to view FDA Patient-Focused Drug Development (PFDD) Guidance - Part 1.



Eleanor Perfetto, BS, MS, PhD, Professor, Department of Practice, Science, and Health Outcomes Research, University of Maryland, Baltimore, MD, USA


Eric Gascho, BA, Senior Vice President, Policy and Government Affairs, National Health Council, Washington, DC, USA

Robyn Bent, RN, CAPT, Patient Focused Drug Development Program Director, Center for Drug Evaluation and Research (CDER), Food & Drug Administration (FDA), Silver Spring, MD, USA

Michelle Tarver, MD, PhD, Deputy Director, Office of Strategic Partnerships and Technology Innovation Program Director for Patient Science, Digital Health Center of Excellence Center for Devices and Radiological Health (CDRH),  Food & Drug Administration (FDA), Silver Spring, MD, USA

Brought to you by: 
ISPOR Patient-Centered Special Interest Group

Please note:
On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.

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

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