FDA Advisory Committee Meetings

2023 Cellular, Tissue, and Gene Therapies Advisory Committee

On October 31st, 2023, the U.S. Food and Drug Administration (FDA) will convene 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 is public and includes an opportunity for voluntary community participation through written and oral comments. 

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

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 24, 2023
• Submit online: HERE (step-by-step instructions are available in the webinar below)
• Include the following information: Docket No. FDA–2023–N–1190 for “Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”

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Resources

We’ve created a few resources to help guide you through the submission process:

• Written Comments Guide – Sick Cells has created a guide to help explain how you can submit your comments and suggested content to include. Click the button below to view the guide.

• Webinar – Sick Cells’ Mariah Scott explains what an FDA Advisory Committee Meeting is and the step-by-step process to submit comments. View the recording below or on our Youtube channel.

Still have questions? Contact Mariah Scott at mscott@sickcells.org