The eRulemaking Program
07/24/2026 | Press release | Distributed by Public on 07/24/2026 06:59
Hearings, Meetings, Proceedings, etc.: Cellular, Tissue, and Gene Therapies Advisory Committee; Biologics License Application 125827, from Replimune, Inc. for Vusolimogene[...]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-7231]
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 30, 2026. The amendment is being made to reflect a change in the DATES , ADDRESSES , and SUPPLEMENTARY INFORMATION : Procedure portion of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Cicely Reese; Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver Spring, MD 20993-0002, 301-796-9025, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION:
In the Federal Register of June 30, 2026, meeting notice and citation, 91 FR 42203, FDA announced that a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee would be held on July 30, 2026. On page 42203, in the second column, the DATES portion of the document is changed to read as follows:
The meeting will be held on July 30, 2026, from 9:30 a.m. to 4:30 p.m. Eastern Time. Online public viewing will be available at the following link on the day of the meeting at: https://youtube.com/live/7x4xuKJti1o?feature=share.
On page 42203, in the second column, the ADDRESSES portion of the document is changed to read as follows: The meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. The public will also have the option to participate, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On page 42204, in the second column, the SUPPLEMENTARY INFORMATION : Procedure portion of the document is changed to read as follows: Oral presentations from the public will be scheduled between approximately 12:35 p.m. and 2:05 p.m. Eastern Time.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ) and 21 CFR part 14, relating to the advisory committees.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-15017 Filed 7-23-26; 8:45 am]
BILLING CODE 4164-01-P
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