Revio is pleased to announce the upcoming 76th Cellular, Tissue, and Gene Therapies Advisory Committee scheduled for October 31, 2023, from 9:00am – 5:00pm ET. Before diving into the agenda and scope of this meeting, we will start by explaining what these meetings with the Agency are.
What is an advisory committee?
The Agency relies on many advisory committees to help them make sound decisions based on the best scientific advice. These committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
The FDA has 49 technical and scientific advisory committees and panels that include scientific experts and members of the public. Each committee typically includes a consumer representative and an industry representative and based on the meeting topic, a patient representative who provides the patient or caregiver experience for a particular disease, condition, or medical product. The FDA uses advisory committees to:
- Get advice from experts who work outside the agency.
- Work toward an open and transparent government.
- Encourage patients, health care providers, and other interested people to share their views during the open public hearing or by submitting comments to the open docket.
Please see, Advisory Committees Give FDA Critical Advice and the Public a Voice for more information.
The meeting will utilize an online teleconferencing and/or video conferencing platform to deliver presentations, ensuring they are accessible through captioning and recorded for later reference. The committee will convene to deliberate and provide suggestions concerning biologics license application (BLA) 125787. The application pertains to exagamglogene autotemcel (exa-cel) and seeks approval for its use in treating sickle cell disease in individuals aged 12 years and older who experience recurrent vaso-occlusive crises.
The FDA plans to provide the public with background materials at least two business days before the meeting. In case the material cannot be posted on the FDA’s website before the meeting, it will be made available to the public during the advisory committee meeting and subsequently posted on the FDA’s website after the meeting concludes.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Furthermore, oral presentations from the public will be scheduled between approximately 12:35 p.m. and 1:35 p.m. Eastern Time on October 31, 2023. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2023-N-1190. Additionally, the docket will close on October 30, 2023.
The online web conference meeting will be available at the following link: https://youtube.com/live/M90IjjxOdQg
For more information regarding the FDA’s cellular, tissue and gene therapies advisory committee meeting, or for detailed instructions on how to submit comments, you can check the official press release here!
Also, we have a dedicated webpage to bring you the latest updates, guidance and developments. You can also follow us on LinkedIn.
We hope you find this useful and of interest. If you would like to discuss any of these updates with the team at REVIO, please get in touch here