Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
Research Review Subcommittee
September 29, 2005 Meeting
Date and Time:
The meeting will be held on September 29, 2005; 8:00 am to 4:00 pm.
Location:
Holiday Inn-Select, 8120 Wisconsin Avenue, Bethesda, MD. 20814, (301) 652-2000.
Contact Persons:
Gail Dapolito or Sheila D. Langford, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting.
Agenda:
The Subcommittee will listen to presentations about the research program at the Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER). The program is intended to provide dynamic, responsive, cutting edge research to contribute to OCTGT's regulatory mission and facilitate development of safe and effective biological products. The Subcommittee will discuss the program and make recommendations that will be publicly discussed at a future meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. Information regarding CBER's scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the internet at: http://www.fda.gov/cber/inside/mission.htm. Information regarding FDA's Critical Path to New Medical Products is available to the public on the internet at http://www.fda.gov/oc/initiatives/criticalpath/.
Oral Presentations:
Between approximately 11:20 am and 12:20 pm oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before September 22, 2005.
Closed Committee Deliberations:
From approximately 1:20 to 4:00 pm the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) (6)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c) (4)). The Subcommittee will discuss internal research programs in the Office of Cellular, Tissue and Gene Therapies, CBER.
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