March 7, 2023
Open to all ISPOR Members and Non-members
Title: FDA Patient-Focused Drug Development (PFDD) Guidance - Part 2
9:00AM EST | 2:00PM UTC | 3:00PM CET
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Description
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series highlights the four methodological guidance documents, which includes two finalized guidances (1 and 2), a draft guidance (3), and guidance that is under development (4.)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• Discuss draft guidance 3, for which a public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.
Resources
It is suggested to review these resources prior to participating in the webinar.
- Assessment of the Use of Patient Experience Data in Regulatory Decision-Making | FDA
- Guidance Overview - FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
- Draft Guidance 3 - Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Click here to view FDA Patient-Focused Drug Development (PFDD) Guidance - Part 1.
- Finalized Guidance 1 - Collecting Comprehensive and Representative Input
- Finalized Guidance 2 - Methods to Identify What is Important to Patients
Moderator:
Eleanor Perfetto, BS, MS, PhD, Professor, Department of Practice, Science, and Health Outcomes Research, University of Maryland, Baltimore, MD, USA
Speakers:
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.