U.S. flag An official website of the United States government
  1. Home
  2. Advisory Committees
  3. Advisory Committee Calendar
  4. October 12, 2017: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement - 10/12/2017 - 10/12/2017
  1. Advisory Committees

Advisory Committee Meeting

Event Title
October 12, 2017: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement
October 12, 2017

Scheduled

Date:
October 12, 2017
Time:
08:30 AM - 05:00 PM EDT
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States



Center Date Time Location
CBER October 12, 2017 8:30 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue,
Silver Spring, MD 20903
Building 31 Conference Center,
the Great Room (Rm. 1503)

Agenda
On October 12, 2017, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Biologics License Application (BLA) 125610, voretigene neparvovec, submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.

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 Advisory Committee calendar main page. Scroll down to the appropriate advisory committee meeting link.

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 October 4, 2017.
  • Oral presentations from the public will be scheduled on October 12, 2017 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 September 26, 2017. 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 September 27, 2017.

For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link: https://collaboration.fda.gov/ctgtac101217.

Contact Information

  • 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. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend.  Webcast will be available at 8:30 a.m. on October 12, 2017 by using the following link. https://collaboration.fda.gov/ctgtac101217. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Prabhakara Atreya or Joanne Lipkind at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures 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

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 FDA Advisory Committee Information 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 disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures 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).