Event

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Open to all ISPOR Members and Non-members

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

Thursday, February 2, 2023
10:00AM EST | 3:00PM UTC | 4:00PM CET

 
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Description

This is part one of a two-part webinar series. The FDA is developing Patient-Focused Drug Development (PFDD) guidance to inform the inclusion of patient experience when developing new medical therapies and products. This is a four-part guidance series, with two final guidances released, a third draft guidance released and a fourth guidance under development. The PFDD guidance is anticipated to be influential in the field of health economics and outcomes research. In this webinar series, we will hear from patients and FDA staff to learn what is covered in this guidance series and what these new guidances mean for patient-focused drug development.

Learning Objectives

• Inform the ISPOR membership about the FDA PFDD initiative in general and the four PFDD Guidances more specifically, and the various ways PFDD might impact the work they do in HEOR, COA, regulatory science, and other areas.
• Provide background on what led up to the legislation that mandated guidance preparation.
• Provide insights on how the guidances can be used.
• Understand the impact and importance of the Use of Patient Experience Data in Regulatory Decision-Making and its integration. 

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
• Finalized Guidance 1 - Collecting Comprehensive and Representative Input
• Finalized Guidance 2 - Methods to Identify What is Important to Patients
• Draft Guidance 3 -  Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments

Moderator:

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

Speakers:

Annie Kennedy, Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, Washington, DC, USA

Selena Daniels, PharmD, PhD, Clinical Outcome Assessment Team Leader, Food & Drug Administration (FDA), Washington, DC, 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.