Cellular, Tissue and Gene Therapies Advisory Committee
February 9-10, 2006 Meeting
Date and Time:
The meeting will be held on February 9, 2006, 8:00 a.m. to 5:30 p.m.; and February 10, 2006, 8:00 a.m. to 1:00 p.m.
Location:
Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD, (301) 977-8900.
Contact Persons:
Gail Dapolito or Rosanna Harvey, 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:
On February 9, 2006, in open session, the Committee will conduct a scientific discussion of potency measurements for cellular, tissue and gene transfer products. On February 10, in the open session, the Committee will 1) discuss the National Toxicology Program on Retroviral Mutagenesis and 2) receive a brief update on the recent review of the research program of the Office of Cellular, Tissue and Gene Therapies, FDA.
Oral Presentations:
Between approximately 1:30 and 2:00 p.m. on February 9; and 9:40 and 10:10 a.m. on February 10, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 2, 2006.
Closed Committee Deliberations:
On February 10, from approximately 11:30 to 1:00 p.m. the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)); and where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The Committee will discuss the report of the Research Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee related to a review of the research program in the Office of Cellular, Tissue and Gene Therapies.
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