FDA Meetings

2026 FDA Patient-Focused Drug Development (PFDD) Meeting for Nonhealing Chronic Wounds

On August 25, 2026, the U.S. Food and Drug Administration (FDA) is hosting a hybrid meeting, Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds. The PFDD will be used by the FDA to obtain input from patients, patient representatives, and care partners about their experiences with nonhealing wounds, including daily impact, management and treatment, and consider when determining whether to participate in a clinical trial. The meeting is public and includes an opportunity for voluntary community participation through written comments and attendance.

We encourage you to participate in this process by submitting a public comment and attending the meeting either in-person or virtually via the webcast. Attendees will have dedicated opportunities to share experiences and insights during the multiple open discussion portions of the agenda. Register to attend here.

Submit Your Written Comment

It’s important that all members of the sickle cell community get their stories heard. Submit your comments and share this information with your friends and family:

• Submit by October 26, 2026
• Submit online: HERE
• Include the following information: Docket ID FDA-2026-N-5057 for Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments, Meeting Date: August 25, 2026

For more information about submitting a written comment, click the button below to view our guide.

2023 Cellular, Tissue, and Gene Therapies Advisory Committee

On October 31st, 2023, the U.S. Food and Drug Administration (FDA) convened the Cellular, Tissue, and Gene Therapies Advisory Committee to discuss exagamglogene autotemcel (exa-cel), a gene therapy for the treatment of Sickle Cell Disease (SCD) for patients between the ages of 12 and 35. The Advisory Committee Meeting will be used by FDA to obtain independent expert advice on scientific, technical, and policy matters. The meeting was public and included an opportunity for voluntary community participation through written and oral comments. 

The meeting was broadcasted live on Youtube. Click the button below to watch the meeting.