CDER Patient-Focused Drug Development
Public Meeting on Patient-Focused Drug Development for Nonhealing Chronic Wounds
On August 25, 2026, FDA is hosting a hybrid public meeting on Patient-Focused Drug Development (PFDD) for Nonhealing Chronic Wounds. This meeting will provide FDA and other key stakeholders, including medical product developers, health care providers, and academic researchers, the opportunity to hear directly from patients, patient representatives, and care partners about their experiences with nonhealing chronic wounds, including how the wounds and associated wound care affect their daily life, what matters most to them, their current approaches for managing or treating their nonhealing chronic wounds, and what they consider when determining whether to participate in a clinical trial.
There will be three sessions focused on: (1) health effects and daily impacts, (2) current approaches to treatment, and (3) perspectives on clinical trials. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and care partner participants in the audience. Panelists are also welcome to participate in the facilitated discussion.
Meeting Logistics and Registration
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Date: August 25, 2026
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Time: 10:00 a.m. – 4:30 p.m. ET
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Registration: https://www.fda.gov/pfddchronicwounds
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Location:
- Attend In Person or Online
- Virtual: Via Webcast
- In Person: FDA White Oak Campus, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993
Panelists
Patients or care partners interested in providing comments as part of the panel discussion are asked to indicate their interest when they register for the meeting. A member of our PFDD Staff will contact them via email. Panelists will be confirmed prior to the meeting and will be invited to a brief one-on-one call with our team to help prepare for their role in the discussion.
The event information webpage will be updated as meeting materials become available.
FDA encourages participants to submit written comments to the public docket by October 26, 2026.
Reminder: Impacts of PFDD Meetings; Request for Information and Comments Due June 30, 2026
FDA issued a request for information and comments to collect examples about how previous PFDD meetings have impacted stakeholders’ drug development efforts.
In response to stakeholder requests to better understand the outcomes of PFDD meetings, FDA is seeking to collect information about their impacts outside of specific regulatory decisions. The Agency recognizes that there are many significant outcomes, such as community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas, that can occur in forums to which FDA is not typically a party. Similarly, changes made by medical product developers in response to patient input may not be communicated to FDA outside of a formal regulatory submission.
FDA invites input from all interested parties, including patient organizations, medical product developers, healthcare providers, and academic researchers. FDA encourages written comments to the public docket by June 30, 2026.
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