Cellular, Tissue and Gene Therapies Advisory Committee
April 10 & 11, 2008 Meeting
Date and Time:
The meeting will be held on April 10, 2008 from 9 a.m. to approximately 6 p.m. and on April 11, 2008 from 8 a.m. to approximately 12 noon.
Location:
Hilton DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, MD, Grand Ballroom.
Contact Persons:
Gail Dapolito or Danielle Cubbage, Food and Drug Administration, 1401 Rockville Pike, HFM-71, Rockville, MD 20853, 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 April 10, 2008, the Committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On April 11, 2008, the Committee will meet to discuss updates on 1) research management related to the September 29, 2005 review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; 2) FDA's Somatic Cell Therapy Letter; and 3) recently released FDA Guidance documents.
Oral Presentations:
Oral presentations from the public will be scheduled on April 10 between approximately 1:45 p.m. and 2:15 p.m. and on April 11 between approximately 10:15 a.m. and 10:45 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 26, 2008.