November 18, 2015: Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee Meeting Announcement

Center	Date	Time	Location
CBER	November 18, 2015	8 a.m. to 5 p.m.	FDA White Oak Campus, White Oak Conference Center, Building 31, Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD 20993

Agenda

The committees will discuss the safety and efficacy of Biologics License Application (BLA) 125593, Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics Inc. The proposed indication (use) for this product is treatment of non-muscle invasive bladder cancer (NMIBC) at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Materials for this meeting will be available at the 2015 Cellular, Tissue and Gene Therapies committee meetings main page.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before November 2, 2015.
Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 12:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 16, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 22, 2015.

Webcast Information

CBER plans to provide a free of charge, live webcast of the November 18, 2015, joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee. While CBER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The link for the webcast is available at:https://collaboration.fda.gov/ctgtacodac111815/.

Contact Information

Janie Kim, 301-796-9016, e-mail: janie.kim@fda.hhs.gov
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.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs.

If you require special accommodations due to a disability, please contact Janie Kim at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions; visitor parking and security can be accessed at the Public meetings at White Oak main page.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site forprocedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Official FR Notice

Advisory Committee Calendar > November 18, 2015: Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee Meeting Announcement