Biotech Values

[Biowatch]

DNDN advisory panel

This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.

Name of Committee: Cellular, Tissue, and Gene Therapies Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on March 29, 2007, from 8
a.m. to approximately 6:30 p.m. and on March 30, 2007 from 8 a.m. to
approximately 3 p.m.
Address: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http:....
Select Docket No. 2007N-0061,

``Sipuleucel-T Dendreon,'' and follow prompts to submit your statement.
Written comments should be submitted to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852, by close of business on March 22, 2007.
All comments received will be posted without change, including any
personal information provided. Comments received on or before March 22,
2007, will be provided to the committee before or at the meeting.
Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD, Grand Ballroom. [Implies wifi available.]
Contact Person: Gail Dapolito or Rosanna L. Harvey, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-1289,
FAX: [phone], 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 March 29, 2007, in open session, the committee will
discuss Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the
treatment of men with asymptomatic metastatic hormone refractory
prostate cancer. The committee will also hear overviews of research
programs in the Division of Cellular and Gene Therapies, Center for
Biologics Evaluation and Research. On March 30, 2007, in open session,
the committee will discuss the draft document entitled ``Guidance for
Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic Reconstitution in
Patients with Hematological Malignancies.'' For a copy of the draft
guidance visit http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http:...

The committee
will also discuss scientific issues regarding minimally manipulated,
unrelated allogeneic peripheral blood stem cells.
FDA intends to make background material available to the public no
later than 1 business day 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. Background material is
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http:...
click on
the year 2007 and scroll down to the appropriate advisory committee
link.
http://www.fda.gov/ohrms/dockets/ac/07acdocs.htm

Procedure: On March 29, 2007, from 8 a.m. to approximately 5:30
p.m., and on March 30, 2007, from 8 a.m. to approximately 3 p.m., the
meeting is open to the public. 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 March 15, 2007. Oral presentations from the public will be
scheduled between approximately 11:30 a.m. and 12:30 p.m. on March 29,
2007, and between 10 a.m. and 11 a.m. on March 30, 2007. Those desiring
to make 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 March 7, 2007. 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 March 8, 2007.

Closed Committee Deliberations: On March 29, 2007, at approximately
5:30 p.m., 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)). The committee will discuss a report of
intramural research programs in the Division of Cellular and Gene
Therapies.

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 Gail Dapolito at
least 7 days in advance of the meeting.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3712.htm